Analgesic Efficacy of Liposomal Bupivacaine vs. Bupivacaine HCL as a Tap Block After Abdominally Based Autologous Breast Reconstruction

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02662036
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Actual Duration (Months): 24.2
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

This study will evaluate the efficacy of analgesia provided by liposomal bupivacaine (Exparel) when compared to bupivacaine HCL as a transverse abdominis plane (TAP) block in terms of discharge milestones, opioid use, costs, and patient-reported satisfaction at 12, 24, and 72 hours. The investigators propose that Exparel will lower opioid use, length of stay, and overall cost of abdominally-based autologous breast reconstruction, and will lead to greater patient satisfaction.

Condition or Disease	Intervention/Treatment	Phase
Mammaplasty	Drug: Bupivicaine HCL; Drug: Liposomal bupivacaine	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: A Prospective Trial to Assess Analgesic Efficacy of Liposomal Bupivacaine vs. Bupivacaine HCL as a Tap Block After Abdominally Based Autologous Breast Reconstruction
• Actual Study Start Date: Feb 29, 2016
• Actual Primary Completion Date: Feb 26, 2018
• Actual Study Completion Date: Mar 8, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1: Bupivicaine -TAP block of 30 cc of 0.25% bupivicaine	Drug: Bupivicaine HCL; Other Names: Bupivicaine
Experimental: Group 2: Liposomal bupivacaine -TAP block of 266 mg/30 cc liposomal bupivacaine	Drug: Liposomal bupivacaine; Other Names: Exparel

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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)]

2. Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Length of Hospital Stay [Up to day of discharge from hospital, up to 7 days]

3. Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Time Until Ambulation [Up to 2 weeks post-operation]

4. Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Duration of Urinary Catheter [Up to 2 weeks post-operation]

5. Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores [12 hours after surgery]

   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

6. Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores [24 hours after surgery]

   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

7. Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores [48 hours after surgery]

   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

8. Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores [72 hours after surgery]

   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

9. Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Change From Baseline in Patient Satisfaction With Recovery [At post operative day 2, discharge, and at 1-2 week follow-up]

   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

10. Cost of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl When Accounting for Length of Hospital Stay and Use of Other Analgesics [Up to 2 weeks post-operation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Scheduled for abdominal-based autologous breast reconstruction (DIEP, MS-TRAM, or TRAM).

• At least 18 years of age.

• Female.

• Able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

• Cognitive impairment.

• History of abdominal surgery precluding free flap donor site.

• Allergy or intolerance to bupivacaine or "amide" anesthetics.

• Significant preoperative chronic pain (requiring daily narcotics) or neuropathic pain (requiring daily use of pregabalin or gabapentin) within the previous 3 months.

• Pregnant or breastfeeding.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University School of Medicine	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

• Washington University School of Medicine

Investigators

• Principal Investigator: Terence Myckatyn, M.D., Washington University School of Medicine

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 1, 2018

More Information

Additional Information:

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Publications

None provided.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT02662036
• Other Study ID Numbers: 201601064
• First Posted: Jan 25, 2016
• Last Update Posted: Feb 18, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Bupivacaine

Study Results

Participant Flow

Arm/Group Title	Group 1: Bupivicaine	Group 2: Liposomal Bupivacaine
Arm/Group Description	-TAP block of 30 cc of 0.25% bupivicaine	-TAP block of 266 mg/30 cc liposomal bupivacaine
Period Title: Overall Study
STARTED	35	35
COMPLETED	22	22
NOT COMPLETED	13	13

Baseline Characteristics

Arm/Group Title	Group 1: Bupivicaine	Group 2: Liposomal Bupivacaine	Total
Arm/Group Description	-TAP block of 30 cc of 0.25% bupivicaine	-TAP block of 266 mg/30 cc liposomal bupivacaine	Total of all reporting groups
Overall Participants	35	35	70
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	51	47	48.5
Sex: Female, Male (Count of Participants)
Female	35 100%	35 100%	70 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 2.9%	0 0%	1 1.4%
Not Hispanic or Latino	32 91.4%	34 97.1%	66 94.3%
Unknown or Not Reported	2 5.7%	1 2.9%	3 4.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	1 2.9%	1 1.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	4 11.4%	5 14.3%	9 12.9%
White	30 85.7%	28 80%	58 82.9%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 2.9%	1 2.9%	2 2.9%
Region of Enrollment (participants) [Number]
United States	35 100%	35 100%	70 100%
Baseline QoR (score on a scale) [Median (Full Range) ]
Median (Full Range) [score on a scale]	134	140	136

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1: Bupivicaine	Group 2: Liposomal Bupivacaine
Arm/Group Description	-TAP block of 30 cc of 0.25% bupivicaine	-TAP block of 266 mg/30 cc liposomal bupivacaine
Measure Participants	22	22
Intraoperative	99.5	110.0
Postoperative acute care unit	0	10
Postoperative floor	165	138.8
Total	300	283

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1: Bupivicaine, Group 2: Liposomal Bupivacaine
	Comments	Statistical analysis #1 is for intraoperative opioid use
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.76
	Comments
	Method	Mann Whitney U Test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group 1: Bupivicaine, Group 2: Liposomal Bupivacaine
	Comments	Statistical analysis #2 is for postoperative acute care unit opioid use
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.38
	Comments
	Method	Mann Whitney U Test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Group 1: Bupivicaine, Group 2: Liposomal Bupivacaine
	Comments	Statistical analysis #3 is for postoperative floor opioid use
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.69
	Comments
	Method	Mann Whitney U Test
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Group 1: Bupivicaine, Group 2: Liposomal Bupivacaine
	Comments	Statistical analysis #4 is for total opioid use
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.98
	Comments
	Method	Mann Whitney U Test
	Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1: Bupivicaine	Group 2: Liposomal Bupivacaine
Arm/Group Description	-TAP block of 30 cc of 0.25% bupivicaine	-TAP block of 266 mg/30 cc liposomal bupivacaine
Measure Participants	22	22
Postoperative acute care unit	0	0
Floor	1	1
Total	1	1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1: Bupivicaine, Group 2: Liposomal Bupivacaine
	Comments	Statistical analysis #1 is for postoperative acute care unit antiemetic use
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.28
	Comments
	Method	Mann Whitney U Test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group 1: Bupivicaine, Group 2: Liposomal Bupivacaine
	Comments	Statistical analysis #2 is for floor antiemetic use
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.62
	Comments
	Method	Mann Whitney U Test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Group 1: Bupivicaine, Group 2: Liposomal Bupivacaine
	Comments	Statistical analysis #3 is for total antiemetic use
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.50
	Comments
	Method	Mann Whitney U Test
	Comments

3. Secondary Outcome

Title	Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Length of Hospital Stay
Time Frame	Up to day of discharge from hospital, up to 7 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1: Bupivicaine	Group 2: Liposomal Bupivacaine
Arm/Group Description	-TAP block of 30 cc of 0.25% bupivicaine	-TAP block of 266 mg/30 cc liposomal bupivacaine
Measure Participants	22	22
Median (Full Range) [days]	3.56	2.91

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1: Bupivicaine, Group 2: Liposomal Bupivacaine
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.20
	Comments
	Method	Mann Whitney U Test
	Comments

4. Secondary Outcome

Title	Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Time Until Ambulation
Time Frame	Up to 2 weeks post-operation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1: Bupivicaine	Group 2: Liposomal Bupivacaine
Arm/Group Description	-TAP block of 30 cc of 0.25% bupivicaine	-TAP block of 266 mg/30 cc liposomal bupivacaine
Measure Participants	22	22
Median (Full Range) [days]	2.20	1.81

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1: Bupivicaine, Group 2: Liposomal Bupivacaine
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.64
	Comments
	Method	Mann Whitney U Test
	Comments

5. Secondary Outcome

Title	Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Duration of Urinary Catheter
Time Frame	Up to 2 weeks post-operation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1: Bupivicaine	Group 2: Liposomal Bupivacaine
Arm/Group Description	-TAP block of 30 cc of 0.25% bupivicaine	-TAP block of 266 mg/30 cc liposomal bupivacaine
Measure Participants	22	22
Median (Full Range) [days]	1.27	1.02

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1: Bupivicaine, Group 2: Liposomal Bupivacaine
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.38
	Comments
	Method	Mann Whitney U Test
	Comments

6. Secondary Outcome

Title	Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores
Description	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
Time Frame	12 hours after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1: Bupivicaine	Group 2: Liposomal Bupivacaine
Arm/Group Description	-TAP block of 30 cc of 0.25% bupivicaine	-TAP block of 266 mg/30 cc liposomal bupivacaine
Measure Participants	22	22
Median (Full Range) [score on a scale]	2.0	0

7. Secondary Outcome

Title	Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores
Description	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
Time Frame	24 hours after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1: Bupivicaine	Group 2: Liposomal Bupivacaine
Arm/Group Description	-TAP block of 30 cc of 0.25% bupivicaine	-TAP block of 266 mg/30 cc liposomal bupivacaine
Measure Participants	22	22
Median (Full Range) [score on a scale]	2.0	3

8. Secondary Outcome

Title	Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores
Description	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
Time Frame	48 hours after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1: Bupivicaine	Group 2: Liposomal Bupivacaine
Arm/Group Description	-TAP block of 30 cc of 0.25% bupivicaine	-TAP block of 266 mg/30 cc liposomal bupivacaine
Measure Participants	22	22
Median (Full Range) [score on a scale]	2	2

9. Secondary Outcome

Title	Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores
Description	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
Time Frame	72 hours after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1: Bupivicaine	Group 2: Liposomal Bupivacaine
Arm/Group Description	-TAP block of 30 cc of 0.25% bupivicaine	-TAP block of 266 mg/30 cc liposomal bupivacaine
Measure Participants	22	22
Median (Full Range) [score on a scale]	2	0.5

10. Secondary Outcome

Title	Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Change From Baseline in Patient Satisfaction With Recovery
Description	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
Time Frame	At post operative day 2, discharge, and at 1-2 week follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1: Bupivicaine	Group 2: Liposomal Bupivacaine
Arm/Group Description	-TAP block of 30 cc of 0.25% bupivicaine	-TAP block of 266 mg/30 cc liposomal bupivacaine
Measure Participants	22	22
Post-operative day 2	-33	-24
Discharge	-10	-6
1-2 week follow-up	-18.5	-10

11. Secondary Outcome

Title	Cost of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl When Accounting for Length of Hospital Stay and Use of Other Analgesics
Time Frame	Up to 2 weeks post-operation

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group 1: Bupivicaine	Group 2: Liposomal Bupivacaine
Arm/Group Description	-TAP block of 30 cc of 0.25% bupivicaine	-TAP block of 266 mg/30 cc liposomal bupivacaine
Measure Participants	0	0

Adverse Events

Time Frame	Adverse events were tracked from first administration of study drug until 30 days following the day of surgery.
Adverse Event Reporting Description	Only adverse events deemed to be serious, unexpected, severe, and related to the study drug will be recorded. Specifically, bleeding requiring blood transfusion, infection requiring readmission or surgery, life-threatening arrhythmias, would healing problems requiring surgical intervention, and reconstructive failures due to flap loss will be recorded and evaluated for relatedness.
Arm/Group Title	Group 1: Bupivicaine		Group 2: Liposomal Bupivacaine
Arm/Group Description	-TAP block of 30 cc of 0.25% bupivicaine		-TAP block of 266 mg/30 cc liposomal bupivacaine
All Cause Mortality
	Group 1: Bupivicaine		Group 2: Liposomal Bupivacaine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/22 (0%)
Serious Adverse Events
	Group 1: Bupivicaine		Group 2: Liposomal Bupivacaine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/22 (0%)
Other (Not Including Serious) Adverse Events
	Group 1: Bupivicaine		Group 2: Liposomal Bupivacaine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/22 (36.4%)		10/22 (45.5%)
Infections and infestations
Breast reconstruction cellulitis	1/22 (4.5%)		0/22 (0%)
Abdominal wound cellulitis	0/22 (0%)		1/22 (4.5%)
Injury, poisoning and procedural complications
Failed Flap	2/22 (9.1%)		3/22 (13.6%)
Wound dehiscence (abdomen requiring local debridement)	4/22 (18.2%)		1/22 (4.5%)
Medical Flap Necrosis requiring debridement	0/22 (0%)		2/22 (9.1%)
Flap Necrosis	0/22 (0%)		1/22 (4.5%)
Flap hematoma requiring evacuation	0/22 (0%)		2/22 (9.1%)
Abdominal hematoma requiring evacauation	0/22 (0%)		1/22 (4.5%)
Partial Flap Loss	0/22 (0%)		1/22 (4.5%)
Late Flap Loss	0/22 (0%)		1/22 (4.5%)
Delayed Pedicle TRAM Flap	1/22 (4.5%)		0/22 (0%)
Fascial dehiscence/hernia	1/22 (4.5%)		0/22 (0%)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism	1/22 (4.5%)		0/22 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.