TRANSCEND: EXPAREL Administered by Infiltration Into the TAP for Prolonged Postsurgical Analgesia in Lower Abdominal Surgeries

• Sponsor: Pacira Pharmaceuticals, Inc (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01919190
• Collaborator: (none)
• Enrollment: 67
• Locations: 13
• Arms: 2
• Duration (Months): 6
• Patients Per Site: 5.2
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

The purpose of this prospective, blinded assessor, randomized trial is to assess opioid use and patient-reported outcomes of EXPAREL as a foundation in postsurgical pain therapy in Transversus Abdominis Plane (TAP) infiltration in lower abdominal surgical procedures.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: EXPAREL; Drug: Placebo	Phase 4

Detailed Description

The purpose of this prospective, blinded assessor, randomized trial is to assess opioid use and patient-reported outcomes of EXPAREL as a foundation in postsurgical pain therapy in Transversus Abdominis Plane (TAP) infiltration in lower abdominal surgical procedures; primary endpoint signal seen during pre-specified interim analysis.

Study Design

• Study Type: Interventional
• Actual Enrollment: 67 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Assessing the Impact of EXPAREL(R) on Opioid Use and Patient Reported Outcomes When Administered by Infiltration Into the Transversus Abdominis Plane (TAP) Under Ultrasound Guidance for Prolonged Postsurgical Analgesia in Lower Abdominal Surgeries
• Study Start Date: Aug 1, 2013
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: EXPAREL EXPAREL (266mg/20 ml) with 40 mL of 0.9% normal saline for a total volume of 60 mL, 30 mL to be administered to the right TAP and 30 mL to be administered to the left TAP	Drug: EXPAREL; TAP with EXPAREL; Other Names: bupivacaine liposome injectable suspension.
Sham Comparator: Placebo The placebo control will be established using a grade-2 sham, no infiltration will occur	Drug: Placebo; Placebo; Other Names: Placebo using grade-2 sham, no infiltration

Outcome Measures

Primary Outcome Measures

1. Total Opioid Consumption Post Surgery (Cumulative Total) Until Discharge Readiness or Post Surgery Day 4 [From surgery through 4 days postsurgery]

   Total Opioid Consumption Post Surgery (cumulative total) Until Discharge Readiness or Post Surgery Day 4

2. Overall Benefit of Analgesic Score (OBAS) at Day 3 [Postsurgical day 1 through day 3]

   Severity of postsurgical pain, satisfaction with pain management, and impact of opioid-related symptom distress measured using the Overall Benefit of Analgesic Score (OBAS) - primary endpoint is mean difference in OBAS at Day 3. (0=minimal pain and 4=maximum imaginable pain)

Secondary Outcome Measures

1. Extent and Degree of Anesthetic Blockade [Prior to TAP, immediately postoperatively, and daily through discharge or Day 4]

   Extent and degree of anesthetic blockage measured using a 5-point sensation scale.

2. Severity of Postsurgical Pain [Immediately in PACU postsurgery and prior to pain medication until discharge (or Day 4)]

   Severity of postsurgical pain measured using an 11-point numerical rating scale (NRS 0-10).

3. Quality of Recovery [Daily through Post Op Day 4]

   Measured using the Quality of Recovery 15 questionnaire (QoR-15)

4. Frequency of Patient Calls Post-discharge [Post-discharge through 4 days postsurgery]

   Frequency of patient calls post-discharge related to pain and unscheduled hospital/surgeon visits

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Males and females >18 years of age

• American Society of Anesthesiologists (ASA) physical status 1-3

• Undergoing either lower abdominal surgery defined as Laparoscopic Hysterectomy (female), Laparoscopic Myomectomy (female), Laparoscopic Colectomy (male/female)

• Physically and mentally able to give full informed consent to participate in this study and complete all study assessments within the timeframes required (including electronic diaries should patient be discharged prior to day 4)

• Capable of returning the diary after POD 4 by mail (preferably) or upon follow up visit.

Exclusion Criteria:

• History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics.

• Any patient whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful local administration of EXPAREL.

• Patients who have received any investigational drug within 30 days prior to EXPAREL administration, or planned administration of another investigational product or procedure during their participation in this study.

• Any chronic condition requiring use of opioids for treatment of a medical condition for 2 weeks or more prior to surgery.

• Confirmed pregnancy at time of enrollment or breast feeding (females of child-bearing potential).

• Patients that would constitute a contraindication to participation in the study, or cause inability to comply with the study requirements.

• Any patient with diagnosed or potential metastatic disease.

• Any condition that in the investigator's opinion might be harmed or be a poor candidate for participation in the study (such as patients requiring long acting opioids as part of the induction medications).

• Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®)

• History of suspected or known addiction to, or abuse of, illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Florida Hospital	Winter Park	Florida	United States	32792
2	Memorial Health University Medical Center	Savannah	Georgia	United States	31404
3	Northwestern University	Chicago	Illinois	United States	60208
4	University of Louisville	Louisville	Kentucky	United States	40202
5	Berkshire Medical Center	Pittsfield	Massachusetts	United States	01210
6	University of Minnesota	Minneapolis	Minnesota	United States	55404
7	Montefiore Medical Center	Bronx	New York	United States	10467
8	Duke University	Durham	North Carolina	United States	27705
9	Fairview Hospital	Cleveland	Ohio	United States	44111
10	The Ohio State University	Columbus	Ohio	United States	43210
11	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107
12	UPMC St. Margaret's Hospital	Pittsburgh	Pennsylvania	United States	15215
13	St. John Hospital	Houston	Texas	United States	77081

Sponsors and Collaborators

• Pacira Pharmaceuticals, Inc

Investigators

• Study Director: Kay Warnott, RN, Pacira Pharmaceuticals, Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pacira Pharmaceuticals, Inc
• ClinicalTrials.gov Identifier: NCT01919190
• Other Study ID Numbers: MSE402
• First Posted: Aug 8, 2013
• Last Update Posted: Jul 2, 2021
• Last Verified: Jun 1, 2021

• Additional relevant MeSH terms: Bupivacaine

Study Results

Participant Flow

Arm/Group Title	EXPAREL	Placebo
Arm/Group Description	EXPAREL (266 mg/20 mL) with 40 mL of 0.9% normal saline for a total volume of 60 mL, 30 mL to be administered to the right TAP and 30 mL to be administered to the left TAP. EXPAREL	The placebo control was established using a grade-2 sham; no infiltration occurred. Placebo
Period Title: Overall Study
STARTED	33	34
COMPLETED	30	34
NOT COMPLETED	3	0

Baseline Characteristics

Arm/Group Title	EXPAREL	Placebo	Total
Arm/Group Description	EXPAREL (266 mg/20 mL) with 40 mL of 0.9% normal saline for a total volume of 60 mL, 30 mL to be administered to the right TAP and 30 mL to be administered to the left TAP. EXPAREL	The placebo control was established using a grade-2 sham; no infiltration occurred. Placebo	Total of all reporting groups
Overall Participants	33	34	67
Age, Customized (participants) [Number]
Under 75	32 97%	33 97.1%	65 97%
Over 75	1 3%	1 2.9%	2 3%
Sex: Female, Male (Count of Participants)
Female	27 81.8%	28 82.4%	55 82.1%
Male	6 18.2%	6 17.6%	12 17.9%
Region of Enrollment (participants) [Number]
United States	33 100%	34 100%	67 100%

Outcome Measures

1. Primary Outcome

Title	Total Opioid Consumption Post Surgery (Cumulative Total) Until Discharge Readiness or Post Surgery Day 4
Description	Total Opioid Consumption Post Surgery (cumulative total) Until Discharge Readiness or Post Surgery Day 4
Time Frame	From surgery through 4 days postsurgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EXPAREL	Placebo
Arm/Group Description	EXPAREL (266 mg/20 mL) with 40 mL of 0.9% normal saline for a total volume of 60 mL, 30 mL to be administered to the right TAP and 30 mL to be administered to the left TAP EXPAREL	The placebo control will be established using a grade-2 sham, no infiltration will occur Placebo
Measure Participants	33	34
Mean (Standard Error) [Opioid consumption (mg)]	3.79 (NA)	3.72 (NA)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EXPAREL, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	>0.8
	Comments
	Method	ANCOVA
	Comments

2. Primary Outcome

Title	Overall Benefit of Analgesic Score (OBAS) at Day 3
Description	Severity of postsurgical pain, satisfaction with pain management, and impact of opioid-related symptom distress measured using the Overall Benefit of Analgesic Score (OBAS) - primary endpoint is mean difference in OBAS at Day 3. (0=minimal pain and 4=maximum imaginable pain)
Time Frame	Postsurgical day 1 through day 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EXPAREL	Placebo
Arm/Group Description	EXPAREL (266 mg/20 mL) with 40 mL of 0.9% normal saline for a total volume of 60 mL, 30 mL to be administered to the right TAP and 30 mL to be administered to the left TAP EXPAREL	The placebo control will be established using a grade-2 sham, no infiltration will occur Placebo
Measure Participants	33	34
Least Squares Mean (Standard Error) [units on a scale]	3.05 (0.56)	4.63 (0.56)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	EXPAREL, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0456
	Comments
	Method	Mixed Models Analysis
	Comments

3. Secondary Outcome

Title	Extent and Degree of Anesthetic Blockade
Description	Extent and degree of anesthetic blockage measured using a 5-point sensation scale.
Time Frame	Prior to TAP, immediately postoperatively, and daily through discharge or Day 4

Outcome Measure Data

Analysis Population Description

The analysis was not conducted due to the early termination of this study.

Arm/Group Title	EXPAREL	Placebo
Arm/Group Description	EXPAREL (266mg /20 mL) with 40 mL of 0.9% normal saline for a total volume of 60 mL, 30 mL to be administered to the right TAP and 30 mL to be administered to the left TAP EXPAREL	The placebo control will be established using a grade-2 sham, no infiltration will occur Placebo
Measure Participants	0	0

4. Secondary Outcome

Title	Severity of Postsurgical Pain
Description	Severity of postsurgical pain measured using an 11-point numerical rating scale (NRS 0-10).
Time Frame	Immediately in PACU postsurgery and prior to pain medication until discharge (or Day 4)

Outcome Measure Data

Analysis Population Description

The analysis was not conducted due to the early termination of this study.

Arm/Group Title	EXPAREL	Placebo
Arm/Group Description	EXPAREL (266 mg/20 mL) with 40 mL of 0.9% normal saline for a total volume of 60 mL, 30 mL to be administered to the right TAP and 30 mL to be administered to the left TAP EXPAREL	The placebo control will be established using a grade-2 sham, no infiltration will occur Placebo
Measure Participants	0	0

5. Secondary Outcome

Title	Quality of Recovery
Description	Measured using the Quality of Recovery 15 questionnaire (QoR-15)
Time Frame	Daily through Post Op Day 4

Outcome Measure Data

Analysis Population Description

The analysis was not conducted due to the early termination of this study.

Arm/Group Title	EXPAREL	Placebo
Arm/Group Description	EXPAREL (266 mg/20 mL) with 40 mL of 0.9% normal saline for a total volume of 60 mL, 30 mL to be administered to the right TAP and 30 mL to be administered to the left TAP EXPAREL	The placebo control will be established using a grade-2 sham, no infiltration will occur Placebo
Measure Participants	0	0

6. Secondary Outcome

Title	Frequency of Patient Calls Post-discharge
Description	Frequency of patient calls post-discharge related to pain and unscheduled hospital/surgeon visits
Time Frame	Post-discharge through 4 days postsurgery

Outcome Measure Data

Analysis Population Description

The analysis was not conducted due to the early termination of this study.

Arm/Group Title	EXPAREL	Placebo
Arm/Group Description	EXPAREL (266 mg/20 mL) with 40 mL of 0.9% normal saline for a total volume of 60 mL, 30 mL to be administered to the right TAP and 30 mL to be administered to the left TAP EXPAREL	The placebo control will be established using a grade-2 sham, no infiltration will occur Placebo
Measure Participants	0	0

Adverse Events

Time Frame	10 days
Arm/Group Title	EXPAREL		Placebo
Arm/Group Description	EXPAREL (266 mg/20 mL) with 40 mL of 0.9% normal saline for a total volume of 60 mL, 30 mL to be administered to the right TAP and 30 mL to be administered to the left TAP EXPAREL		The placebo control will be established using a grade-2 sham, no infiltration will occur Placebo
All Cause Mortality
	EXPAREL		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	EXPAREL		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/33 (3%)		1/34 (2.9%)
Blood and lymphatic system disorders
Postoperative anemia exacerbation	0/33 (0%)	0	1/34 (2.9%)	1
Gastrointestinal disorders
Postoperative abdominal hemorrhage	1/33 (3%)	1	0/34 (0%)	0
Investigations
Subtherapeutic international normalized ration (INR)	0/33 (0%)	0	1/34 (2.9%)	1
Other (Not Including Serious) Adverse Events
	EXPAREL		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/34 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.