Natural History of Pain After Shoulder Arthroplasty Condu... | NCT03021096

Natural History of Pain After Shoulder Arthroplasty Condu... | NCT03021096 | Trialant

Arms/Interventions Module

Name	Type	Description	Arm Group Labels	Other Names
Surveys	Other	The study is just using validated surveys to assess pain and mood states after surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Numeric Rating Scale Pain Scores at Post-operative Day 14	Quantifying patients' pain at a sub-acute time point after surgery at rest and with movement. The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".	14 days after surgery for each patient

Secondary Outcomes

Measure	Description	Time Frame
Numeric Rating Scale (NRS) Pain With Movement and at Rest.	The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". A lower score is a better outcome.	Days 1 day (POD0), 3 days(POD3), 7 days(POD7) and 3 months(POD90) after surgery

Contacts/Locations Module

Name	Affiliation	Role
Jacques YaDeau, MD, PhD	Hospital for Special Surgery, New York	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Hospital for Special Surgery		New York	New York	10021	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25050091	Background	Goon AK, Dines DM, Craig EV, Gordon MA, Goytizolo EA, Lin Y, Lin E, YaDeau JT. A clinical pathway for total shoulder arthroplasty-a pilot study. HSS J. 2014 Jul;10(2):100-6. doi: 10.1007/s11420-014-9381-0. Epub 2014 Mar 8.
26814246	Background	YaDeau JT, Gordon MA, Goytizolo EA, Lin Y, Fields KG, Goon AK, Holck G, Miu TW, Gulotta LV, Dines DM, Craig EV. Buprenorphine, Clonidine, Dexamethasone, and Ropivacaine for Interscalene Nerve Blockade: A Prospective, Randomized, Blinded, Ropivacaine Dose-Response Study. Pain Med. 2016 May;17(5):940-60. doi: 10.1093/pm/pnv010. Epub 2015 Dec 14.

Arm/Group Information

ID	Title	Description
FG000	Total Shoulder Surgery Patients	In the operating room, patients received intravenous sedation of up to 5 mg of midazolam, 10 to 20 mg of ketamine, and propofol as deemed appropriate. An ultrasound-guided interscalene peripheral nerve block was performed in the operating room, before surgery, using 25 mL bupivacaine, 0.5%, with added 100 mg clonidine, 2 mg preservative free dexamethasone, and 150 mg buprenorphine. During the procedure, patients received either intravenous sedation with a propofol infusion, or general anesthesia with propofol induction, either laryngeal mask airway or endotracheal tube insertion, and general anesthesia maintenance with titrated propofol and 1% sevoflurane. For the intravenous sedation and general anesthesia groups, patients received ketamine (total of 50 mg), ondansetron (4 mg), famotidine (20 mg), dexamethasone (4 mg) and ketorolac (15 mg) during surgery. For postoperative analgesia, patients received intravenous acetaminophen (1000 mg every 6 hours, four total doses) and intravenous ketorolac (15 mg every 8 hours, for three postoperative doses in addition to one dose in the operating room) followed by oral acetaminophen (650 mg every 6 hours for 3 days) and oral meloxicam (7.5-15 mg per day). Oral opioids were available on demand, based on patient description of pain to the nursing staff as mild, moderate, or severe. Each patient also received intravenous patient-controlled analgesia of hydromorphone.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG000108 subjects
COMPLETED		FG000102 subjects
NOT COMPLETED		FG0006 subjects

Type	Comment	Reasons
Lost to Follow-up		FG0004 subjects
Protocol Violation		FG0002 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Total Shoulder Surgery Patients	In the operating room, patients received intravenous sedation of up to 5 mg of midazolam, 10 to 20 mg of ketamine, and propofol as deemed appropriate. An ultrasound-guided interscalene peripheral nerve block was performed in the operating room, before surgery, using 25 mL bupivacaine, 0.5%, with added 100 mg clonidine, 2 mg preservative free dexamethasone, and 150 mg buprenorphine. During the procedure, patients received either intravenous sedation with a propofol infusion, or general anesthesia with propofol induction, either laryngeal mask airway or endotracheal tube insertion, and general anesthesia maintenance with titrated propofol and 1% sevoflurane. For the intravenous sedation and general anesthesia groups, patients received ketamine (total of 50 mg), ondansetron (4 mg), famotidine (20 mg), dexamethasone (4 mg) and ketorolac (15 mg) during surgery. For postoperative analgesia, patients received intravenous acetaminophen (1000 mg every 6 hours, four total doses) and intravenous ketorolac (15 mg every 8 hours, for three postoperative doses in addition to one dose in the operating room) followed by oral acetaminophen (650 mg every 6 hours for 3 days) and oral meloxicam (7.5-15 mg per day). Oral opioids were available on demand, based on patient description of pain to the nursing staff as mild, moderate, or severe. Each patient also received intravenous patient-controlled analgesia of hydromorphone.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

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

Numeric Rating Scale Pain Scores at Post-operative Day 14

Quantifying patients' pain at a sub-acute time point after surgery at rest and with movement.

The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".

Posted

Mean

Standard Deviation

score on a scale

14 days after surgery for each patient

ID	Title	Description
OG000	Total Shoulder Surgery Patients	In the operating room, patients received intravenous sedation of up to 5 mg of midazolam, 10 to 20 mg of ketamine, and propofol as deemed appropriate. An ultrasound-guided interscalene peripheral nerve block was performed in the operating room, before surgery, using 25 mL bupivacaine, 0.5%, with added 100 mg clonidine, 2 mg preservative free dexamethasone, and 150 mg buprenorphine. During the procedure, patients received either intravenous sedation with a propofol infusion, or general anesthesia with propofol induction, either laryngeal mask airway or endotracheal tube insertion, and general anesthesia maintenance with titrated propofol and 1% sevoflurane. For the intravenous sedation and general anesthesia groups, patients received ketamine (total of 50 mg), ondansetron (4 mg), famotidine (20 mg), dexamethasone (4 mg) and ketorolac (15 mg) during surgery. For postoperative analgesia, patients received intravenous acetaminophen (1000 mg every 6 hours, four total doses) and intravenous ketorolac (15 mg every 8 hours, for three postoperative doses in addition to one dose in the operating room) followed by oral acetaminophen (650 mg every 6 hours for 3 days) and oral meloxicam (7.5-15 mg per day). Oral opioids were available on demand, based on patient description of pain to the nursing staff as mild, moderate, or severe. Each patient also received intravenous patient-controlled analgesia of hydromorphone.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Total Shoulder Surgery Patients	In the operating room, patients received intravenous sedation of up to 5 mg of midazolam, 10 to 20 mg of ketamine, and propofol as deemed appropriate. An ultrasound-guided interscalene peripheral nerve block was performed in the operating room, before surgery, using 25 mL bupivacaine, 0.5%, with added 100 mg clonidine, 2 mg preservative free dexamethasone, and 150 mg buprenorphine. During the procedure, patients received either intravenous sedation with a propofol infusion, or general anesthesia with propofol induction, either laryngeal mask airway or endotracheal tube insertion, and general anesthesia maintenance with titrated propofol and 1% sevoflurane. For the intravenous sedation and general anesthesia groups, patients received ketamine (total of 50 mg), ondansetron (4 mg), famotidine (20 mg), dexamethasone (4 mg) and ketorolac (15 mg) during surgery. For postoperative analgesia, patients received intravenous acetaminophen (1000 mg every 6 hours, four total doses) and intravenous ketorolac (15 mg every 8 hours, for three postoperative doses in addition to one dose in the operating room) followed by oral acetaminophen (650 mg every 6 hours for 3 days) and oral meloxicam (7.5-15 mg per day). Oral opioids were available on demand, based on patient description of pain to the nursing staff as mild, moderate, or severe. Each patient also received intravenous patient-controlled analgesia of hydromorphone.

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Dr Jacques Yadeau	Hospital for Special Surgery, Anesthesiology	2126061036		Yadeauj@hss.edu

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Apr 15, 2022	Sep 13, 2024	Prot_SAP_000.pdf

Condition Browse Module

ID	Term
D003288	Contusions
D010149	Pain, Postoperative

ID	Term
D014949	Wounds, Nonpenetrating
D014947	Wounds and Injuries
D011183	Postoperative Complications
D010335	Pathologic Processes

Intervention Browse Module

ID	Term
D011795	Surveys and Questionnaires

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Secondary

Numeric Rating Scale (NRS) Pain With Movement and at Rest.

some patients did not fill out questionnaire or were lost to follow up.

Posted

Mean

Standard Deviation

score on a scale

Days 1 day (POD0), 3 days(POD3), 7 days(POD7) and 3 months(POD90) after surgery

ID	Title	Description
OG000	Total Shoulder Surgery Patients	In the operating room, patients received intravenous sedation of up to 5 mg of midazolam, 10 to 20 mg of ketamine, and propofol as deemed appropriate. An ultrasound-guided interscalene peripheral nerve block was performed in the operating room, before surgery, using 25 mL bupivacaine, 0.5%, with added 100 mg clonidine, 2 mg preservative free dexamethasone, and 150 mg buprenorphine. During the procedure, patients received either intravenous sedation with a propofol infusion, or general anesthesia with propofol induction, either laryngeal mask airway or endotracheal tube insertion, and general anesthesia maintenance with titrated propofol and 1% sevoflurane. For the intravenous sedation and general anesthesia groups, patients received ketamine (total of 50 mg), ondansetron (4 mg), famotidine (20 mg), dexamethasone (4 mg) and ketorolac (15 mg) during surgery. For postoperative analgesia, patients received intravenous acetaminophen (1000 mg every 6 hours, four total doses) and intravenous ketorolac (15 mg every 8 hours, for three postoperative doses in addition to one dose in the operating room) followed by oral acetaminophen (650 mg every 6 hours for 3 days) and oral meloxicam (7.5-15 mg per day). Oral opioids were available on demand, based on patient description of pain to the nursing staff as mild, moderate, or severe. Each patient also received intravenous patient-controlled analgesia of hydromorphone.

Units	Counts
Participants	OG000102

Title

Denominators

Categories

NRS POD1 at rest

- ParticipantsOG000101

Title	Measurements
	OG0001.6± 2.1

NRS POD1 with movement

- ParticipantsOG000

Secondary

Opioid Consumption (in Past 24 Hours)

Measured in milligrams taken. A lower consumption is a better outcome.

some patients were lost to follow up.

Posted

Median

Inter-Quartile Range

oral morphine equivalents (mg)

Days 1 day, 3 days, 7 days after surgery

ID	Title	Description
OG000	Total Shoulder Surgery Patients	In the operating room, patients received intravenous sedation of up to 5 mg of midazolam, 10 to 20 mg of ketamine, and propofol as deemed appropriate. An ultrasound-guided interscalene peripheral nerve block was performed in the operating room, before surgery, using 25 mL bupivacaine, 0.5%, with added 100 mg clonidine, 2 mg preservative free dexamethasone, and 150 mg buprenorphine. During the procedure, patients received either intravenous sedation with a propofol infusion, or general anesthesia with propofol induction, either laryngeal mask airway or endotracheal tube insertion, and general anesthesia maintenance with titrated propofol and 1% sevoflurane. For the intravenous sedation and general anesthesia groups, patients received ketamine (total of 50 mg), ondansetron (4 mg), famotidine (20 mg), dexamethasone (4 mg) and ketorolac (15 mg) during surgery. For postoperative analgesia, patients received intravenous acetaminophen (1000 mg every 6 hours, four total doses) and intravenous ketorolac (15 mg every 8 hours, for three postoperative doses in addition to one dose in the operating room) followed by oral acetaminophen (650 mg every 6 hours for 3 days) and oral meloxicam (7.5-15 mg per day). Oral opioids were available on demand, based on patient description of pain to the nursing staff as mild, moderate, or severe. Each patient also received intravenous patient-controlled analgesia of hydromorphone.

Units	Counts
Participants	OG000102

Title

Denominators

Categories

POD1

Title	Measurements
	OG00017.5(3.9 to 50.1)

POD3

Title	Measurements
	OG00030(7.4 to 63.2)

POD7

Secondary

Opioid Related Symptom Distress Scale

The Opioid-Related Symptom Distress Scale (ORSDS) is calculated by taking the average of the three symptom distress dimensions. Frequency will be assessed using a 4 point scale: 1, rarely 2, occasionally 3, frequently 4, almost constantly with 1 being the lowest and 4 being the highest. Severity is assessed using a 4 point scale: 1, slight 2, moderate 3, severe 4, very severe with 1 being the lowest and 4 being the highest. Bothersomeness is assessed using a 5 point scale: 1, not at all 2, a little bit 3, somewhat 4, quite a bit 5, very much with 1 being the lowest and 5 being the highest.

A higher score indicates worse outcomes. The total score for each participant is calculated and the median score for all participants is reported.

Posted

Median

Inter-Quartile Range

score on a scale

Day 1 after surgery

ID	Title	Description
OG000	Total Shoulder Surgery Patients	In the operating room, patients received intravenous sedation of up to 5 mg of midazolam, 10 to 20 mg of ketamine, and propofol as deemed appropriate. An ultrasound-guided interscalene peripheral nerve block was performed in the operating room, before surgery, using 25 mL bupivacaine, 0.5%, with added 100 mg clonidine, 2 mg preservative free dexamethasone, and 150 mg buprenorphine. During the procedure, patients received either intravenous sedation with a propofol infusion, or general anesthesia with propofol induction, either laryngeal mask airway or endotracheal tube insertion, and general anesthesia maintenance with titrated propofol and 1% sevoflurane. For the intravenous sedation and general anesthesia groups, patients received ketamine (total of 50 mg), ondansetron (4 mg), famotidine (20 mg), dexamethasone (4 mg) and ketorolac (15 mg) during surgery. For postoperative analgesia, patients received intravenous acetaminophen (1000 mg every 6 hours, four total doses) and intravenous ketorolac (15 mg every 8 hours, for three postoperative doses in addition to one dose in the operating room) followed by oral acetaminophen (650 mg every 6 hours for 3 days) and oral meloxicam (7.5-15 mg per day). Oral opioids were available on demand, based on patient description of pain to the nursing staff as mild, moderate, or severe. Each patient also received intravenous patient-controlled analgesia of hydromorphone.

Units	Counts
Participants	OG000102

Title

Denominators

Categories

Title	Measurements
	OG0000.3(0.1 to 0.5)

Secondary

Range of Motion

Measure the ability of shoulder movement from 0 to 180 degrees at these follow up visits with the surgeon after surgery.

some patients were lost to follow up or did not answer questionnaire.

Posted

Mean

Standard Deviation

degrees

Day 14 after surgery and 3 months after surgery

ID	Title	Description
OG000	Total Shoulder Surgery Patients	In the operating room, patients received intravenous sedation of up to 5 mg of midazolam, 10 to 20 mg of ketamine, and propofol as deemed appropriate. An ultrasound-guided interscalene peripheral nerve block was performed in the operating room, before surgery, using 25 mL bupivacaine, 0.5%, with added 100 mg clonidine, 2 mg preservative free dexamethasone, and 150 mg buprenorphine. During the procedure, patients received either intravenous sedation with a propofol infusion, or general anesthesia with propofol induction, either laryngeal mask airway or endotracheal tube insertion, and general anesthesia maintenance with titrated propofol and 1% sevoflurane. For the intravenous sedation and general anesthesia groups, patients received ketamine (total of 50 mg), ondansetron (4 mg), famotidine (20 mg), dexamethasone (4 mg) and ketorolac (15 mg) during surgery. For postoperative analgesia, patients received intravenous acetaminophen (1000 mg every 6 hours, four total doses) and intravenous ketorolac (15 mg every 8 hours, for three postoperative doses in addition to one dose in the operating room) followed by oral acetaminophen (650 mg every 6 hours for 3 days) and oral meloxicam (7.5-15 mg per day). Oral opioids were available on demand, based on patient description of pain to the nursing staff as mild, moderate, or severe. Each patient also received intravenous patient-controlled analgesia of hydromorphone.

Units	Counts
Participants	OG000102

Title

Denominators

Categories

14 days after surgery extension

- ParticipantsOG00026

Title	Measurements
	OG00015.8± 5.8

3 months after surgery extension

- ParticipantsOG000

Secondary

Severity of Bruising

Surgeon will assess each individual patient to determine whether bruising occurred and if so, the size and severity of the bruise.

some patients were lost to follow up or did not complete questionnaire. 32 people were reported to have bruising and size (in centimeters) of their bruises were measured.

Posted

Mean

Standard Deviation

Day 14 after surgery

ID	Title	Description
OG000	Total Shoulder Surgery Patients	In the operating room, patients received intravenous sedation of up to 5 mg of midazolam, 10 to 20 mg of ketamine, and propofol as deemed appropriate. An ultrasound-guided interscalene peripheral nerve block was performed in the operating room, before surgery, using 25 mL bupivacaine, 0.5%, with added 100 mg clonidine, 2 mg preservative free dexamethasone, and 150 mg buprenorphine. During the procedure, patients received either intravenous sedation with a propofol infusion, or general anesthesia with propofol induction, either laryngeal mask airway or endotracheal tube insertion, and general anesthesia maintenance with titrated propofol and 1% sevoflurane. For the intravenous sedation and general anesthesia groups, patients received ketamine (total of 50 mg), ondansetron (4 mg), famotidine (20 mg), dexamethasone (4 mg) and ketorolac (15 mg) during surgery. For postoperative analgesia, patients received intravenous acetaminophen (1000 mg every 6 hours, four total doses) and intravenous ketorolac (15 mg every 8 hours, for three postoperative doses in addition to one dose in the operating room) followed by oral acetaminophen (650 mg every 6 hours for 3 days) and oral meloxicam (7.5-15 mg per day). Oral opioids were available on demand, based on patient description of pain to the nursing staff as mild, moderate, or severe. Each patient also received intravenous patient-controlled analgesia of hydromorphone.

Units	Counts
Participants	OG00032

Title

Denominators

Categories

Title	Measurements
	OG0001.5± 1.9

Secondary

Hospital Anxiety and Depression Scale

The Hospital Anxiety and Depression Scale (HADS) measures anxiety and depression in a general medical population of patients. a lower score is a better outcome. Each item on the questionnaire is scored from 0-3 and a person's total score can ranged from 0 = normal and 21 = abnormal for either anxiety or depression.

Scale range:

0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)

A total score for each participant was calculated and then all participants' scores were averaged.

Posted

Mean

Standard Deviation

score on a scale

Day 1 after surgery

ID	Title	Description
OG000	Total Shoulder Surgery Patients	In the operating room, patients received intravenous sedation of up to 5 mg of midazolam, 10 to 20 mg of ketamine, and propofol as deemed appropriate. An ultrasound-guided interscalene peripheral nerve block was performed in the operating room, before surgery, using 25 mL bupivacaine, 0.5%, with added 100 mg clonidine, 2 mg preservative free dexamethasone, and 150 mg buprenorphine. During the procedure, patients received either intravenous sedation with a propofol infusion, or general anesthesia with propofol induction, either laryngeal mask airway or endotracheal tube insertion, and general anesthesia maintenance with titrated propofol and 1% sevoflurane. For the intravenous sedation and general anesthesia groups, patients received ketamine (total of 50 mg), ondansetron (4 mg), famotidine (20 mg), dexamethasone (4 mg) and ketorolac (15 mg) during surgery. For postoperative analgesia, patients received intravenous acetaminophen (1000 mg every 6 hours, four total doses) and intravenous ketorolac (15 mg every 8 hours, for three postoperative doses in addition to one dose in the operating room) followed by oral acetaminophen (650 mg every 6 hours for 3 days) and oral meloxicam (7.5-15 mg per day). Oral opioids were available on demand, based on patient description of pain to the nursing staff as mild, moderate, or severe. Each patient also received intravenous patient-controlled analgesia of hydromorphone.

Units	Counts
Participants	OG000102

Title

Denominators

Categories

Anxiety

Title	Measurements
	OG0004.1± 3.3

Depression

Title	Measurements
	OG0003.9± 2.7

Secondary

PainOUT Questionnaire

The PainOUT questionnaire assess pain intensity, quality of pain, and satisfaction with pain management. The questionnaire measured the following:

Worst pain: On a 0-10 scale, where 0 means "no pain" and 10 means "worst possible pain". Higher scores reflect more severity.
Pain severity: On a scale 0-10, where 0 means "very unsatisfied" and 10 means "very satisfied". Higher scores means more satisfaction.
Interference with sleep: Rated on a 0-10 scale, where 0 means "does not interfere" and 10 means "completely interfere" A higher rating means more interference.
Nausea & Itching: Both rated on a 0-10 scale, where 0 means "none" and 10 means "severe". A higher rating means more severe.
Drowsiness: Rated on a 0-10 scale, where 0 means "not at all" and 10 means "extremely". A higher rating means more severe.

Each question score for each participant was added up and divided by the total number of participants to obtain an average score of 0-10 at each timepoint.

some patients were lost to follow up.

Posted

Mean

Inter-Quartile Range

score on a scale

Day 1 and 14 after surgery

ID	Title	Description
OG000	Total Shoulder Surgery Patients	In the operating room, patients received intravenous sedation of up to 5 mg of midazolam, 10 to 20 mg of ketamine, and propofol as deemed appropriate. An ultrasound-guided interscalene peripheral nerve block was performed in the operating room, before surgery, using 25 mL bupivacaine, 0.5%, with added 100 mg clonidine, 2 mg preservative free dexamethasone, and 150 mg buprenorphine. During the procedure, patients received either intravenous sedation with a propofol infusion, or general anesthesia with propofol induction, either laryngeal mask airway or endotracheal tube insertion, and general anesthesia maintenance with titrated propofol and 1% sevoflurane. For the intravenous sedation and general anesthesia groups, patients received ketamine (total of 50 mg), ondansetron (4 mg), famotidine (20 mg), dexamethasone (4 mg) and ketorolac (15 mg) during surgery. For postoperative analgesia, patients received intravenous acetaminophen (1000 mg every 6 hours, four total doses) and intravenous ketorolac (15 mg every 8 hours, for three postoperative doses in addition to one dose in the operating room) followed by oral acetaminophen (650 mg every 6 hours for 3 days) and oral meloxicam (7.5-15 mg per day). Oral opioids were available on demand, based on patient description of pain to the nursing staff as mild, moderate, or severe. Each patient also received intravenous patient-controlled analgesia of hydromorphone.

Units	Counts
Participants	OG000102

Title

Denominators

Categories

POD1 - Worst pain

- ParticipantsOG00097

Title	Measurements
	OG0002(0 to 5)

POD14 - Worst pain

- ParticipantsOG000

Secondary

Pain Catastrophizing Scale (PCS)

The pain catastrophizing scale (PCS) evaluates a person's pain experience by asking them how they feel and what they think about when they are in pain.

The questionnaire uses a 5-point Likert scale, with answers ranging from 0 (never) to 4. (always). The total score is the sum of the individual item scores and ranges from 0 to 52. A lower score indicates a more positive outcome.

Posted

Mean

Standard Deviation

score on a scale

Day of Surgery

ID	Title	Description
OG000	Total Shoulder Surgery Patients	In the operating room, patients received intravenous sedation of up to 5 mg of midazolam, 10 to 20 mg of ketamine, and propofol as deemed appropriate. An ultrasound-guided interscalene peripheral nerve block was performed in the operating room, before surgery, using 25 mL bupivacaine, 0.5%, with added 100 mg clonidine, 2 mg preservative free dexamethasone, and 150 mg buprenorphine. During the procedure, patients received either intravenous sedation with a propofol infusion, or general anesthesia with propofol induction, either laryngeal mask airway or endotracheal tube insertion, and general anesthesia maintenance with titrated propofol and 1% sevoflurane. For the intravenous sedation and general anesthesia groups, patients received ketamine (total of 50 mg), ondansetron (4 mg), famotidine (20 mg), dexamethasone (4 mg) and ketorolac (15 mg) during surgery. For postoperative analgesia, patients received intravenous acetaminophen (1000 mg every 6 hours, four total doses) and intravenous ketorolac (15 mg every 8 hours, for three postoperative doses in addition to one dose in the operating room) followed by oral acetaminophen (650 mg every 6 hours for 3 days) and oral meloxicam (7.5-15 mg per day). Oral opioids were available on demand, based on patient description of pain to the nursing staff as mild, moderate, or severe. Each patient also received intravenous patient-controlled analgesia of hydromorphone.

Units	Counts
Participants	OG000102

Title

Denominators

Categories

Title	Measurements
	OG00012± 11.9

Secondary

Fibromyalgia Scale. a Lower Score is a Better Outcome.

The symptom severity (SS) scale assesses four symptoms that are thought to be defining in a fibromyalgia diagnosis.

The four symptoms assessed by the criteria are as follows:

Fatigue
Waking from sleep feeling unrefreshed
Cognitive symptoms (including trouble concentrating, confusion, disorientation, and impaired comprehension)
Somatic symptoms (physical sensations such as pain, dizziness, nausea, fainting, or bowel disorders)

Each of the 4 symptoms is graded on a scale of 0 to 3, with 0 indicating no symptoms, 1 indicating mild symptoms, 2 indicating moderate symptoms, and 3 indicating severe symptoms. The sum of the scores for each of the 4 symptoms is summed to produce the SS total score. The SS total score has a minimum score of 0 and a maximum score of 12.

The higher score means worst outcome. The sum score for each participant is calculated and then the average score for all participants is reported.

Posted

Mean

Standard Deviation

score on a scale

Day of Surgery

ID	Title	Description
OG000	Total Shoulder Surgery Patients	In the operating room, patients received intravenous sedation of up to 5 mg of midazolam, 10 to 20 mg of ketamine, and propofol as deemed appropriate. An ultrasound-guided interscalene peripheral nerve block was performed in the operating room, before surgery, using 25 mL bupivacaine, 0.5%, with added 100 mg clonidine, 2 mg preservative free dexamethasone, and 150 mg buprenorphine. During the procedure, patients received either intravenous sedation with a propofol infusion, or general anesthesia with propofol induction, either laryngeal mask airway or endotracheal tube insertion, and general anesthesia maintenance with titrated propofol and 1% sevoflurane. For the intravenous sedation and general anesthesia groups, patients received ketamine (total of 50 mg), ondansetron (4 mg), famotidine (20 mg), dexamethasone (4 mg) and ketorolac (15 mg) during surgery. For postoperative analgesia, patients received intravenous acetaminophen (1000 mg every 6 hours, four total doses) and intravenous ketorolac (15 mg every 8 hours, for three postoperative doses in addition to one dose in the operating room) followed by oral acetaminophen (650 mg every 6 hours for 3 days) and oral meloxicam (7.5-15 mg per day). Oral opioids were available on demand, based on patient description of pain to the nursing staff as mild, moderate, or severe. Each patient also received intravenous patient-controlled analgesia of hydromorphone.

Units	Counts
Participants	OG000102

Title

Denominators

Categories

Title	Measurements
	OG0005.5± 3.4