Analgesic Efficacy of Liposomal Bupivacaine vs. Bupivacai... | NCT02662036

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1: Bupivicaine	Active Comparator	-TAP block of 30 cc of 0.25% bupivicaine	Drug: Bupivicaine HCL
Group 2: Liposomal bupivacaine	Experimental	-TAP block of 266 mg/30 cc liposomal bupivacaine	Drug: Liposomal bupivacaine

Name	Type	Description	Arm Group Labels	Other Names
Bupivicaine HCL	Drug		Group 1: Bupivicaine	Bupivicaine
Liposomal bupivacaine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Opioid Use During Hospital Stay		Up to day of discharge from hospital (expected hospital stay of 5 days)

Secondary Outcomes

Measure	Description	Time Frame
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Antiemetic Use During the Hospital Stay		Up to day of discharge from hospital (expected hospital stay of 5 days)
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Length of Hospital Stay

Eligibility Module

Name	Affiliation	Role
Terence Myckatyn, M.D.	Washington University School of Medicine	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Washington University School of Medicine		St Louis	Missouri	63110	United States

Label	URL
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine	View source

Results Section

Participant Flow Module

ID	Title	Description
FG000	Group 1: Bupivicaine	-TAP block of 30 cc of 0.25% bupivicaine
FG001	Group 2: Liposomal Bupivacaine	-TAP block of 266 mg/30 cc liposomal bupivacaine

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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	Nov 1, 2018

ID	Title	Description
BG000	Group 1: Bupivicaine	-TAP block of 30 cc of 0.25% bupivicaine
BG001	Group 2: Liposomal Bupivacaine	-TAP block of 266 mg/30 cc liposomal bupivacaine
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00035 BG00135 BG00270

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Median

Full Range

years

Title

Denominators

Categories

Intraoperative

Title	Measurements
	OG00099.5(15 to 220) OG001110.0(42 to 215)

Postoperative acute care unit

Title	Measurements
	OG000

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
OG000 OG001	Statistical analysis #1 is for intraoperative opioid use	Mann Whitney U Test		0.76														Superiority
OG000 OG001	Statistical analysis #2 is for postoperative acute care unit opioid use	Mann Whitney U Test

Secondary

Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Antiemetic Use During the Hospital Stay

Posted

Median

Full Range

Up to day of discharge from hospital (expected hospital stay of 5 days)

ID	Title	Description
OG000	Group 1: Bupivicaine	-TAP block of 30 cc of 0.25% bupivicaine
OG001	Group 2: Liposomal Bupivacaine	-TAP block of 266 mg/30 cc liposomal bupivacaine

Units	Counts
Participants	OG000

Secondary

Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Length of Hospital Stay

Posted

Median

Full Range

days

Up to day of discharge from hospital, up to 7 days

ID	Title	Description
OG000	Group 1: Bupivicaine	-TAP block of 30 cc of 0.25% bupivicaine
OG001	Group 2: Liposomal Bupivacaine	-TAP block of 266 mg/30 cc liposomal bupivacaine

Units	Counts
Participants	OG000

Secondary

Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Time Until Ambulation

Posted

Median

Full Range

days

Up to 2 weeks post-operation

ID	Title	Description
OG000	Group 1: Bupivicaine	-TAP block of 30 cc of 0.25% bupivicaine
OG001	Group 2: Liposomal Bupivacaine	-TAP block of 266 mg/30 cc liposomal bupivacaine

Units	Counts
Participants	OG00022

Secondary

Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Duration of Urinary Catheter

Posted

Median

Full Range

days

Up to 2 weeks post-operation

ID	Title	Description
OG000	Group 1: Bupivicaine	-TAP block of 30 cc of 0.25% bupivicaine
OG001	Group 2: Liposomal Bupivacaine	-TAP block of 266 mg/30 cc liposomal bupivacaine

Units	Counts
Participants	OG00022

Secondary

Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores

Pain scale uses Wong-Baker FACES Pain Rating Scale
The scale uses cartoon faces ranging from 0-10 with 0 meaning no pain and 10 meaning worst possible pain

Posted

Median

Full Range

score on a scale

12 hours after surgery

ID	Title	Description
OG000	Group 1: Bupivicaine	-TAP block of 30 cc of 0.25% bupivicaine
OG001	Group 2: Liposomal Bupivacaine	-TAP block of 266 mg/30 cc liposomal bupivacaine

Units	Counts
Participants	OG000

Secondary

Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores

Pain scale uses Wong-Baker FACES Pain Rating Scale
The scale uses cartoon faces ranging from 0-10 with 0 meaning no pain and 10 meaning worst possible pain

Posted

Median

Full Range

score on a scale

24 hours after surgery

ID	Title	Description
OG000	Group 1: Bupivicaine	-TAP block of 30 cc of 0.25% bupivicaine
OG001	Group 2: Liposomal Bupivacaine	-TAP block of 266 mg/30 cc liposomal bupivacaine

Units	Counts
Participants	OG000

Secondary

Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores

Pain scale uses Wong-Baker FACES Pain Rating Scale
The scale uses cartoon faces ranging from 0-10 with 0 meaning no pain and 10 meaning worst possible pain

Posted

Median

Full Range

score on a scale

48 hours after surgery

ID	Title	Description
OG000	Group 1: Bupivicaine	-TAP block of 30 cc of 0.25% bupivicaine
OG001	Group 2: Liposomal Bupivacaine	-TAP block of 266 mg/30 cc liposomal bupivacaine

Units	Counts
Participants	OG000

Secondary

Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores

Pain scale uses Wong-Baker FACES Pain Rating Scale
The scale uses cartoon faces ranging from 0-10 with 0 meaning no pain and 10 meaning worst possible pain

Posted

Median

Full Range

score on a scale

72 hours after surgery

ID	Title	Description
OG000	Group 1: Bupivicaine	-TAP block of 30 cc of 0.25% bupivicaine
OG001	Group 2: Liposomal Bupivacaine	-TAP block of 266 mg/30 cc liposomal bupivacaine

Units	Counts
Participants	OG000

Secondary

Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Change From Baseline in Patient Satisfaction With Recovery

Quality of Recovery -15 questionnaire
Part A has 10 questions that asks how the participant has been feeling in the last 24 hours with answers ranging from 0=none of the time to 10=all of the time
Part B has 5 questions asking the participant if they have had any of the following including pain, nausea, vomiting, anxiety, and depression) with answers ranging from 0=none of the time to 10=all of the time.
The total score allowed is 150 (range 0-150) with the higher the number the worse the participant is feeling and the lower the number the better the participant is feeling

Posted

Median

Full Range

score on a scale

At post operative day 2, discharge, and at 1-2 week follow-up

ID	Title	Description
OG000	Group 1: Bupivicaine	-TAP block of 30 cc of 0.25% bupivicaine
OG001	Group 2: Liposomal Bupivacaine	-TAP block of 266 mg/30 cc liposomal bupivacaine

Units	Counts
Participants

Secondary

Cost of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl When Accounting for Length of Hospital Stay and Use of Other Analgesics

Data was not collected for this outcome measure. There was no funding to collect or analyze the data. Also it was determined that the concept of cost was highly variable at the hospital and any data that was obtained would lack granular costs on most items. Lacking this granularity would make any results meaningless.

Posted

Up to 2 weeks post-operation

ID	Title	Description
OG000	Group 1: Bupivicaine	-TAP block of 30 cc of 0.25% bupivicaine
OG001	Group 2: Liposomal Bupivacaine	-TAP block of 266 mg/30 cc liposomal bupivacaine

Units	Counts
Participants	OG000

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	Group 1: Bupivicaine	-TAP block of 30 cc of 0.25% bupivicaine	0	22	0	22	8	22
EG001	Group 2: Liposomal Bupivacaine	-TAP block of 266 mg/30 cc liposomal bupivacaine	0	22	0	22	10	22

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Failed Flap	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0002 affected22 at risk EG0013 affected22 at risk
Wound dehiscence (abdomen requiring local debridement)	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0004 affected22 at risk EG0011 affected22 at risk
Medical Flap Necrosis requiring debridement	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected22 at risk EG0012 affected22 at risk
Flap Necrosis	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected22 at risk
Flap hematoma requiring evacuation	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected22 at risk EG0012 affected22 at risk
Breast reconstruction cellulitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0001 affected22 at risk EG0010 affected22 at risk
Abdominal wound cellulitis	Infections and infestations	CTCAE (4.0)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected22 at risk
Abdominal hematoma requiring evacauation	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected22 at risk
Partial Flap Loss	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected22 at risk
Late Flap Loss	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0000 affected22 at risk EG0011 affected22 at risk
Delayed Pedicle TRAM Flap	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected22 at risk EG0010 affected22 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	CTCAE (4.0)	Systematic Assessment	EG0001 affected22 at risk EG0010 affected22 at risk
Fascial dehiscence/hernia	Injury, poisoning and procedural complications	CTCAE (4.0)	Systematic Assessment	EG0001 affected22 at risk EG0010 affected22 at risk