Surgical Pain After Inguinal Hernia Repair (SPAIHR) | NCT00551135

Label	Type	Intervention Names
3	Experimental	Drug: Pregabalin
4	Placebo Comparator	Drug: placebo
2	Experimental	Drug: Pregabalin
1	Experimental	Drug: Pregabalin

Name	Type	Description	Arm Group Labels	Other Names
Pregabalin	Drug	150 mg BID	3
placebo

Measure	Description	Time Frame
Modified Brief Pain Inventory-Short Form (mBPI-sf): Worst Pain 24 Hours Post Surgery	m-BPI-sf: a self-administered 11-point Likert rating scale to rate pain in the past 24 hours. A single item pertains to worst pain in the past 24 hours: range of 0 (no pain) to 10 (worst imaginable pain).	24 hours post surgery

Measure	Description	Time Frame
Numeric Rating Scale (NRS): Current Pain With Movement - Sitting	NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by sitting (sitting in a standardized fashion after being in a fully supine position); range: 0 (no pain) to 10 (worst pain).	Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, and 7 PS; and End of Treatment (EOT [Day 7 PS or Early Termination])

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Birmingham	Alabama	35235	United States
Pfizer Investigational Site

PubMed Identifier	Type	Citation	Retractions
25565885	Derived	Singla NK, Chelly JE, Lionberger DR, Gimbel J, Sanin L, Sporn J, Yang R, Cheung R, Knapp L, Parsons B. Pregabalin for the treatment of postoperative pain: results from three controlled trials using different surgical models. J Pain Res. 2014 Dec 23;8:9-20. doi: 10.2147/JPR.S67841. eCollection 2015.

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	Pregabalin 50 mg	Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
FG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Modified Brief Pain Inventory-Short Form (mBPI-sf): Worst Pain 24 Hours Post Surgery

m-BPI-sf: a self-administered 11-point Likert rating scale to rate pain in the past 24 hours. A single item pertains to worst pain in the past 24 hours: range of 0 (no pain) to 10 (worst imaginable pain).

Modified Intent-to-Treat Population (MITT): all subjects included in intent-to-treat population who took study medication 12 and 2 hours prior to surgery, had no complications during herniorrhaphy, and had the post-surgery primary efficacy measurement. Data from 1 site excluded due to Good Clinical Practices (GCP) deviations.

Posted

Least Squares Mean

Standard Error

scores on scale

24 hours post surgery

ID	Title	Description
OG000	Pregabalin 50 mg	Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
OG001	Pregabalin 150 mg	Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
OG002	Pregabalin 300 mg	Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
OG003	Placebo	Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.

Units	Counts
Participants	OG000102 OG00199 OG002101 OG003

Title

Denominators

Categories

Title	Measurements
	OG0005.2± 0.24 OG0015.4± 0.25 OG0024.7± 0.24 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG002 OG003	LS Means from ANOVA model with terms of treatment, pooled center and baseline worst pain (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.	ANOVA		0.0668	Hochberg's adjustment applied to p-value; Hochberg's adjusted p-value was the primary analysis.					2-Sided								Superiority or Other (legacy)

Secondary

Numeric Rating Scale (NRS): Current Pain With Movement - Sitting

NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by sitting (sitting in a standardized fashion after being in a fully supine position); range: 0 (no pain) to 10 (worst pain).

MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).

Posted

Least Squares Mean

Standard Error

scores on scale

Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, and 7 PS; and End of Treatment (EOT [Day 7 PS or Early Termination])

ID	Title	Description
OG000	Pregabalin 50 mg	Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
OG001	Pregabalin 150 mg	Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
OG002

Secondary

Numeric Rating Scale (NRS): Current Pain With Movement - Walking

NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by walking (rising from sitting position and walking approximately 5 meters or 16 feet at a moderate pace); range: 0 (no pain) to 10 (worst pain).

MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).

Posted

Least Squares Mean

Standard Error

scores on scale

Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, and 7 PS; and End of Treatment (EOT [Day 7 PS or Early Termination])

ID	Title	Description
OG000	Pregabalin 50 mg	Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
OG001	Pregabalin 150 mg	Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
OG002

Secondary

Numeric Rating Scale (NRS): Current Pain With Movement - Coughing

NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by coughing (coughing two times while sitting); range: 0 (no pain) to 10 (worst pain)

MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).

Posted

Least Squares Mean

Standard Error

scores on scale

Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, and 7 PS; and End of Treatment (EOT [Day 7 PS or Early Termination])

ID	Title	Description
OG000	Pregabalin 50 mg	Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
OG001	Pregabalin 150 mg	Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
OG002	Pregabalin 300 mg

Secondary

Numeric Rating Scale (NRS): Current Pain With Movement - Area Under the Curve (AUC) for Sitting, Walking, and Coughing

NRS: a self-administered questionnaire to rate pain. AUC from 1 h PS through 48 h PS for ratings of pain caused by movements of sitting, walking, and coughing; Range: 0 (no pain) to 10 (worst pain).

MITT; 1 site excluded for GCP deviations; n=subjects with analyzable data at observation (pregabalin 50, 150, and 300 mg, and placebo, respectively).

Posted

Least Squares Mean

Standard Error

scores on scale

1 hour through 48 hours post surgery

ID	Title	Description
OG000	Pregabalin 50 mg	Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
OG001	Pregabalin 150 mg	Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
OG002	Pregabalin 300 mg

Secondary

Numerical Rating Scale (NRS): Current Pain at Rest

NRS: a self-administered questionnaire to rate pain. A single item asks participant to rate current pain at rest (preceding pain with movement); range: 0 (no pain) to 10 (worst pain).

MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).

Posted

Least Squares Mean

Standard Error

scores on scale

2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, 7, 8, 9, and 10 PS

ID	Title	Description
OG000	Pregabalin 50 mg	Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
OG001	Pregabalin 150 mg	Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
OG002	Pregabalin 300 mg

Secondary

Numeric Rating Scale (NRS): Current Pain at Rest - Area Under the Curve (AUC)

NRS: a self-administered questionnaire to rate pain. AUC for a single item asking participant to rate current pain at rest (preceding pain with movement); range: 0 (no pain) to 10 (worst pain).

MITT; data from 1 site excluded due to GCP deviations.

Posted

Least Squares Mean

Standard Error

score on scale

1 through 48 hours post surgery (PS)

ID	Title	Description
OG000	Pregabalin 50 mg	Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
OG001	Pregabalin 150 mg	Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
OG002	Pregabalin 300 mg	Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.

Secondary

Numeric Rating Scale (NRS): Average Pain

NRS: a self-administered questionnaire to rate pain. A single item asks participant to rate pain on average in the last 24 hours; range: 0 (no pain) to 10 (worst pain).

MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).

Posted

Least Squares Mean

Standard Error

scores on scale

2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 1, 2, 3, 4, 5, 6, and 7 PS

ID	Title	Description
OG000	Pregabalin 50 mg	Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
OG001	Pregabalin 150 mg	Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
OG002	Pregabalin 300 mg

Secondary

Time From End of Surgery to First Rescue Medication

Rescue medication includes both naproxen and narcotic medication (including tramadol and opioid analgesics). For subjects without use of rescue medication, the time-to-event variable is censored at the Beginning of Taper Visit (Day 7 PS) or at time of withdrawal.

MITT; data from 1 site excluded due to GCP deviations. No descriptive statistics were generated.

Posted

Day 1 through Day 7 post surgery

ID	Title	Description
OG000	Pregabalin 50 mg	Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
OG001	Pregabalin 150 mg	Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
OG002	Pregabalin 300 mg	Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.

Secondary

Time From End of Surgery to Reach a Total Score of at Least 9 on the Post-Anesthetic Discharge Scoring System (PADS)

PADS is a 5-item scale (individual item range: 0-2; higher scores indicating better readiness for hospital discharge). Total score range: 0-10, with 9 or higher indicating eligibility for discharge. End of surgery is time of transfer to post-anesthesia care unit (PACU). Subjects who did not reach a score of 9 on PADS were censored at the date and time of discharge.

MITT; data from 1 site excluded due to GCP deviations. No descriptive statistics were generated.

Posted

Day 1

ID	Title	Description
OG000	Pregabalin 50 mg	Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
OG001	Pregabalin 150 mg	Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
OG002	Pregabalin 300 mg

Secondary

Time From End of Surgery to Discharge From Post-Anesthesia Care Unit (PACU)

MITT; data from 1 site excluded due to GCP deviations. Data not analyzed as planned.

Posted

Day 1

ID	Title	Description
OG000	Pregabalin 50 mg	Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
OG001	Pregabalin 150 mg	Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
OG002	Pregabalin 300 mg	Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
OG003	Placebo

Secondary

Daily Sleep Interference Rating Scale (DSIRS) Score

DSIRS: self-administered 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep [unable to sleep due to pain]) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Performed daily on awakening, prior to taking study medication.

MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).

Posted

Least Squares Mean

Standard Error

scores on a scale

Days 2, 3, 4, 5, 6, 7, 8, 9, and 10 post surgery (PS)

ID	Title	Description
OG000	Pregabalin 50 mg	Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
OG001	Pregabalin 150 mg	Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
OG002

Secondary

Total Cumulative Dose of Opioids and Tramadol Used During and After Surgery

Total cumulative dose of opioids and tramadol administered by any route during surgery and postoperatively. Dose of tramadol calculated as milligrams (mg) of oral morphine equivalent.

MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively). During surgery data not analyzed as planned.

Posted

Least Squares Mean

Standard Error

24, 48, and 72 hours (h) post surgery (PS), and Days 4, 5, 6, and 7 PS

ID	Title	Description
OG000	Pregabalin 50 mg	Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
OG001	Pregabalin 150 mg	Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
OG002	Pregabalin 300 mg

Secondary

Amount of Non-opioid Rescue Medication (Naproxen and Antiemetic Medications) Used During the Study

Total cumulative dose of naproxen calculated in milligrams (mg) from the end of surgery up to and including Day 7 after surgery.

MITT; data from 1 site excluded due to GCP deviations. Amount of antiemetic rescue medications not analyzed as planned.

Posted

Least Squares Mean

Standard Error

End of Surgery through Day 7 post surgery

ID	Title	Description
OG000	Pregabalin 50 mg	Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
OG001	Pregabalin 150 mg	Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
OG002	Pregabalin 300 mg	Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.

Secondary

Total Clinically Meaningful Event (CME) Score and Cumulative Total Distinct CME Score Using the Opioid-Related Symptom Distress Scale (OR-SDS)

OR-SDS: a self-administered assessment of 10 common opioid-related side effects (symptoms). A CME is a severe or very severe symptom (or moderate or greater severity symptom of confusion). The Total Distinct CME score is the sum of CMEs across symptoms (range: 0 [none] to 10 [10 CMEs]); the Cumulative Total Distinct (CT Distinct) CME score is the sum of Total Distinct CME scores at observation and prior observations. The Total CME score is the same as the Total Distinct CME score except that only 1 CME is counted if both nausea and vomiting (or retching) occur (range: 0 [none] to 9 [9 CMEs]).

MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).

Posted

Least Squares Mean

Standard Error

scores on a scale

3, 24, and 72 hours (h) Post-Surgery (PS), and End of Treatment (EOT [Day 7 PS or Early Termination])

ID	Title	Description
OG000	Pregabalin 50 mg	Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
OG001	Pregabalin 150 mg

Secondary

Participants With Clinically Meaningful Events (CMEs) for Individual Symptoms Using the Opioid-Related Symptom Distress Scale (OR-SDS)

MITT; data from 1 site excluded due to GCP deviations.

Posted

Number

participants

3, 24, and 72 hours (h) post surgery (PS), and End of Treatment (EOT [Day 7 PS or Early Termination])

ID	Title	Description
OG000	Pregabalin 50 mg	Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
OG001	Pregabalin 150 mg	Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
OG002	Pregabalin 300 mg

Secondary

Subject Global Evaluation of Study Medication (GESM)

GESM is a self-administered overall impression (global evaluation) of study medication received for pain; 4 categories: poor, fair, good, and excellent.

MITT; data from 1 site excluded due to GCP deviations

Posted

Number

participants

24 hours (h) post surgery (PS) and End of Treatment (EOT [Day 7 PS or Early Termination])

ID	Title	Description
OG000	Pregabalin 50 mg	Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
OG001	Pregabalin 150 mg	Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
OG002	Pregabalin 300 mg	Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.

Secondary

Participants With Wound Healing Complications

Investigator-assigned mutually exclusive categories of: 1) no surgical wound complication, 2) superficial incisional surgical site infection, 3) deep incisional surgical site infection, 4) organ or space surgical site infection, or 5) non-infectious wound healing complication.

Operated subjects within the safety population. Safety population=all randomized subjects administered at least 1 dose of study drug and for whom at least 1 post-baseline safety evaluation was obtained.

Posted

Number

participants

Day 7 post surgery (PS) and up to 30 days PS

ID	Title	Description
OG000	Pregabalin 50 mg	Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
OG001	Pregabalin 150 mg	Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
OG002	Pregabalin 300 mg

Secondary

Participants With Physician Contacts Post-discharge

Number of participants who answered "yes" to the Post-Surgery Contact question: "From the time you were discharged from the hospital, did you have to contact any type of physician because of pain, difficulty getting up and walking about, or difficulty with passing urine?"

MITT; data from 1 site excluded due to GCP deviations

Posted

Number

participants

24 and 72 hours (h) post surgery (PS)

ID	Title	Description
OG000	Pregabalin 50 mg	Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
OG001	Pregabalin 150 mg	Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
OG002	Pregabalin 300 mg	Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.

Secondary

Baseline and Change From Baseline in Anxiety Visual Analog Scale (VAS) Score

Anxiety VAS is a single-item self-administered continuous measure of anxiety using a 100-millimeter (mm) line on which the subject is asked to place a mark indicating the intensity of current anxiety. The score is the distance in mm from the left-most point on the line to the subject's mark; range: 0 (Not at all anxious) at the left-most point to 100 (Extremely anxious) at the right-most point. Performed prior to blood draws.

MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).

Posted

Least Squares Mean

Standard Error

scores on a scale

Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h PS; Days 2, 3, 4, 5, 6, 7, 8, and 9 PS

ID	Title	Description
OG000	Pregabalin 50 mg	Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
OG001	Pregabalin 150 mg	Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.

Secondary

Baseline and Change From Baseline in EuroQol (EQ-5D) Health State Profile Score

EQ-5D is a self-administered questionnaire to assess health-related quality of life in 5 domains (mobility, self care, usual activities, pain or discomfort, and anxiety or depression). Scores from the 5 domains are used to calculate a single index value: the Health State Profile Score; range: 0.0 (death) to 1.0 (perfect health), higher scores indicating better health state.

MITT; data from 1 site excluded due to GCP deviations.

Posted

Least Squares Mean

Standard Error

scores on scales

Baseline and End of Treatment (EOT [Day 7 post surgery or Early Termination])

ID	Title	Description
OG000	Pregabalin 50 mg	Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
OG001	Pregabalin 150 mg	Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
OG002	Pregabalin 300 mg

Secondary

Change From Baseline in Pain Catastrophizing Scale (PCS) Total Score and Subscales

The PCS is a self-administered questionnaire with 13 items, each scored from 0 (not at all) to 4 (all the time) for extent to which participant catastrophizes postoperative pain. Total score is sum of scores for all questions (range: 0 to 52); Subscale scores: Rumination (sum of scores for 4 items; range: 0 to 16); Magnification (sum of scores for 3 items; range: 0 to 12); and Helplessness (sum of scores for 6 items; range: 0 to 24); higher scores mean a greater extent of pain catastrophizing.

MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).

Posted

Least Squares Mean

Standard Error

scores on a scale

3 hours (h) post surgery (PS) and End of Treatment (EOT [Day 7 PS or Early Termination])

ID	Title	Description
OG000	Pregabalin 50 mg	Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
OG001	Pregabalin 150 mg	Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.

Secondary

Relationship Between Baseline and Postoperative Pain Catastrophizing Scale (PCS) Score and Severity of Acute Pain and to Response to Therapy

MITT; data from 1 site excluded due to GCP deviations. Data not analyzed as planned.

Posted

Baseline and Days 1 and 7 post surgery (PS)

ID	Title	Description
OG000	Pregabalin 50 mg	Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
OG001	Pregabalin 150 mg	Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
OG002	Pregabalin 300 mg

Secondary

Baseline and Change From Baseline in Short Form Acute Health Survey 12-Item Version (SF-12v2) Physical Component Summary Score (PCSS) and Mental Component Summary Score (MCSS)

PCSS and MCSS are component summary scores from the self-administered SF-12v2 acute health quality of life, norm-based survey. PCSS range: 4.95 to 76.13; MCSS range: -0.79 to 79.69; lowest scores mean very much below and highest scores mean very much above the general population average.

MITT; data from 1 site excluded due to GCP deviations.

Posted

Least Squares Mean

Standard Error

scores on a scale

Baseline and End of Treatment (EOT [Day 7 post surgery or Early Termination])

ID	Title	Description
OG000	Pregabalin 50 mg	Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
OG001	Pregabalin 150 mg	Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
OG002	Pregabalin 300 mg

Secondary

Participants With Chronic Postoperative Pain

Number of participants who reported surgery-related pain at assessment (by answering 'yes' to a single question: "In the last 24 hours, have you had pain in the area affected by your surgery?")

MITT; data from 1 site excluded due to GCP deviations; n=number of subjects with analyzable data at observation (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively).

Posted

Number

participants

1, 3, and 6 months (mo) post surgery (PS)

ID	Title	Description
OG000	Pregabalin 50 mg	Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
OG001	Pregabalin 150 mg	Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
OG002	Pregabalin 300 mg	Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.

Secondary

Chronic Postoperative Pain: Pain Severity Index Score and Pain Interference Index Score on the Modified Brief Pain Inventory-Short Form (mBPI-sf)

m-BPI-sf: a self-administered 11-point Likert rating scale to rate pain in the past 24 hours. Pain interference index score is mean of 7 individual item scores for interference of pain with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life); range: 0 (does not interfere) to 10 (completely interferes with functional activities). Pain severity index score is mean of 4 individual item scores for pain severity (pain right now, and worst, least, and average pain); range: 0 (no pain) to 10 (worst imaginable pain).

MITT; data from 1 site excluded due to GCP deviations; n=number of subjects who reported surgery-related pain at assessment (pregabalin 50 mg, pregabalin 150 mg, pregabalin 300 mg, and placebo, respectively). Data insufficient for standard deviation calculation at 6 mo PS.

Posted

Mean

Standard Deviation

scores on a scale

1, 3, and 6 months (mo) post surgery (PS)

ID	Title	Description
OG000	Pregabalin 50 mg	Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
OG001	Pregabalin 150 mg

Secondary

Chronic Postoperative Pain: Total Score and Subscale Scores Using the Neuropathic Pain Symptom Inventory (NPSI)

NPSI: a 12-item self-administered questionnaire to assess the characteristics of neuropathic pain on average in the last 24 hours. 5 subscale scores include: burning spontaneous (spont.) pain, pressing spont. pain, paroxysmal pain, evoked pain, and paresthesia or dysesthesia (paresth/dysesth) (range: 0 [no pain] to 10 [worst pain imaginable]); total score calculated from the 5 pain subscores (range: 0 to 0.5), higher scores meaning worse pain.

Posted

Mean

Standard Deviation

scores on a scale

1, 3, and 6 months (mo) post surgery (PS)

ID	Title	Description
OG000	Pregabalin 50 mg	Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
OG001	Pregabalin 150 mg	Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Pregabalin 50 mg	Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.	3	108	46	108
EG001	Pregabalin 150 mg	Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.	1	106	44	106
EG002	Pregabalin 300 mg	Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.	0	103	56	103
EG003	Placebo	Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.	3	108	45	108

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected108 at risk EG0010 affected106 at risk EG0020 affected103 at risk EG0031 affected108 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected108 at risk EG0010 affected106 at risk EG0020 affected103 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected108 at risk EG0010 affected106 at risk EG0020 affected103 at risk EG003
Pyrexia	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected108 at risk EG0010 affected106 at risk EG0020 affected103 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected108 at risk EG0010 affected106 at risk EG0020 affected103 at risk EG003
Amnesia	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected108 at risk EG0011 affected106 at risk EG0020 affected103 at risk EG003
Guillain-Barre syndrome	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected108 at risk EG0010 affected106 at risk EG0020 affected103 at risk EG003
Haematoma	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected108 at risk EG0010 affected106 at risk EG0020 affected103 at risk EG003

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bradycardia	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0003 affected108 at risk EG0010 affected106 at risk EG0020 affected103 at risk EG0031 affected108 at risk
Constipation	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG00021 affected108 at risk EG00122 affected106 at risk EG00227 affected103 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG00021 affected108 at risk EG00118 affected106 at risk EG00214 affected103 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected108 at risk EG0017 affected106 at risk EG0021 affected103 at risk EG003
Fatigue	General disorders	MedDRA 12.0	Systematic Assessment	EG00024 affected108 at risk EG00118 affected106 at risk EG00223 affected103 at risk EG003
Pain	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected108 at risk EG0010 affected106 at risk EG0023 affected103 at risk EG003
Pyrexia	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected108 at risk EG0010 affected106 at risk EG0021 affected103 at risk EG003
Incision site pruritus	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected108 at risk EG0011 affected106 at risk EG0024 affected103 at risk EG003
Disturbance in attention	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG00011 affected108 at risk EG00111 affected106 at risk EG00215 affected103 at risk EG003
Dizziness	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG00015 affected108 at risk EG00120 affected106 at risk EG00229 affected103 at risk EG003
Headache	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0005 affected108 at risk EG0013 affected106 at risk EG0021 affected103 at risk EG003
Somnolence	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG00024 affected108 at risk EG00125 affected106 at risk EG00225 affected103 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0006 affected108 at risk EG0013 affected106 at risk EG0028 affected103 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected108 at risk EG0010 affected106 at risk EG0023 affected103 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG00010 affected108 at risk EG0016 affected106 at risk EG00210 affected103 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected108 at risk EG0013 affected106 at risk EG0022 affected103 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0009 affected108 at risk EG0017 affected106 at risk EG0024 affected103 at risk EG003
Hypotension	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0007 affected108 at risk EG0013 affected106 at risk EG0024 affected103 at risk EG003

ID	Term
D010149	Pain, Postoperative
D006552	Hernia, Inguinal

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D046449	Hernia, Abdominal
D006547	Hernia
D020763	Pathological Conditions, Anatomical

ID	Title	Description
BG000	Pregabalin 50 mg	Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
BG001	Pregabalin 150 mg	Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
BG002	Pregabalin 300 mg	Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
BG003	Placebo	Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
BG004	Total	Total of all reporting groups

ID	Term
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates
D002087	Butyrates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins