TAP-patients With Robotic Assisted Lap Prostatectomy

• Sponsor: Pacira Pharmaceuticals, Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01582477
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Months): 4
• Patients Per Site Per Month: 6

Study Details

Study Description

Brief Summary

The purpose of the study is to assess the safety and efficacy of EXPAREL when administered via infiltration into the transversus abdominis plane (TAP) to prolonged postsurgical analgesia in men undergoing robot-assisted laparoscopic prostatectomy.

Condition or Disease	Intervention/Treatment	Phase
Postsurgical Pain; Analgesia; Prostatectomy	Drug: EXPAREL 20 mL; Drug: EXPAREL 40 mL	Phase 4

Detailed Description

Assess the safety and efficacy of EXPAREL when administered via infiltration into the transversus abdominis plane (TAP) to provide prolonged postsurgical analgesia in men undergoing robot-assisted laparoscopic prostatectomy. The primary endpoint is the duration of abdominal analgesia from the infiltration into the TAP as measured by the time to the subject's first postsurgical opioid administration.

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Safety and Efficacy of EXPAREL When Administered by Infiltration Into the Transversus Abdominis Plane (TAP) for Prolonged Postsurgical Analgesia in Subjects Undergoing Robot-assisted Laparoscopic Prostatectomy
• Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EXPAREL 20 mL (undiluted) 20 mL (266 mg) undiluted EXPAREL with 133 mg infiltrated on each the right and left side of the abdomen.	Drug: EXPAREL 20 mL; EXPAREL 266 mg (undiluted); Other Names: bupivacaine liposome injectable suspension
Active Comparator: EXPAREL 40 mL (diluted) 20 mL (266 mg) EXPAREL diluted with an equal volume of preservative-free 0.9% normal saline to a total of 40 mL and infiltrated equally to the right and left side of the abdomen.	Drug: EXPAREL 40 mL; EXPAREL 266 mg diluted with preservative-free 0.9% normal saline to 40 mL.; Other Names: bupivacaine liposome injectable suspension

Outcome Measures

Primary Outcome Measures

1. The Duration of Abdominal Analgesia From Infiltration Into the TAP [First postsurgical administration of an opioid]

Secondary Outcome Measures

1. Subject Reported Postsurgical Pain [1, 2, 6, 12, 24, 48, 72, 96 hours and 10 days after TAP]

   11-point numeric rating scale (NRS) (0-10, where 0=no pain, 10=worst possible pain)

2. Physician/Healthcare Professional Assessed Postsurgical Pain [1, 2, 6, 12, 24 hours after TAP]

   11-point NRS (0-10, 0=no pain, 10=worst possible pain)

3. Total Postsurgical Oxycodone/Acetaminophen Consumption From Hospital Discharge Through Hour 96. [48, 72, 96 hours]

   Number of pills

4. Incidence of Prespecified Opioid-related Adverse Events [Until hospital discharge order was written, anticipated at 24 hours.]

   Number of subjects

5. Overall Rating of Subject Satisfaction With Postsurgical Pain Control [24 hours, 72 hours, and day 10]

   Mean of subject satisfaction offered on a 5-point Likert scale (1 = extremely dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = extremely satisfied)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• male subjects, aged 18-75.

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

• Undergoing robot-assisted laparoscopic prostatectomy performed by a single surgeon (Ingolf Tuerk, MD).

• Subjects must be physically and mentally able to participate in the study and complete all study assessments.

• Subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the TAP infiltration.

Exclusion Criteria:

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

• Inability to tolerate oxycodone with acetaminophen (e.g. Percocet).

• Any subject whose anatomy or surgical procedure in the opinion of the Investigator might preclude the potential successful performance of a TAP.

• Any subject who in the opinion of the Investigator might be harmed or be a poor candidate for participation in the study.

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Steward St. Elizabeth's	Brighton	Massachusetts	United States	02135

Sponsors and Collaborators

• Pacira Pharmaceuticals, Inc

Investigators

• Principal Investigator: Andrew Sternlicht, MD, Steward St. Elizabeth's

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pacira Pharmaceuticals, Inc
• ClinicalTrials.gov Identifier: NCT01582477
• Other Study ID Numbers: MA402S23B701
• First Posted: Apr 20, 2012
• Last Update Posted: Jun 14, 2021
• Last Verified: Jun 1, 2021

• Keywords provided by Pacira Pharmaceuticals, Inc: TAP, robot-assisted prostatectomy
• Additional relevant MeSH terms: Pain, Postoperative; Bupivacaine

Study Results

Participant Flow

Arm/Group Title	EXPAREL 20 mL	EXPAREL 40 mL
Arm/Group Description	Group receiving EXPAREL 20 mL	Group receiving EXPAREL 40 mL
Period Title: Overall Study
STARTED	12	12
COMPLETED	12	12
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	EXPAREL 20 mL	EXPAREL 40 mL	Total
Arm/Group Description	Group receiving EXPAREL 20 mL	Group receiving EXPAREL 40 mL	Total of all reporting groups
Overall Participants	12	12	24
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	6 50%	9 75%	15 62.5%
>=65 years	6 50%	3 25%	9 37.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.7 (7.24)	61.7 (7.01)	61.2 (6.99)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	12 100%	12 100%	24 100%
Region of Enrollment (participants) [Number]
United States	12 100%	12 100%	24 100%

Outcome Measures

1. Primary Outcome

Title	The Duration of Abdominal Analgesia From Infiltration Into the TAP
Time Frame	First postsurgical administration of an opioid

Outcome Measure Data

Analysis Population Description

Per protocol

Arm/Group Title	EXPAREL 20 mL	EXPAREL 40 mL
Arm/Group Description	Group receiving EXPAREL 20 mL	Group receiving EXPAREL 40 mL
Measure Participants	12	12
Median (Inter-Quartile Range) [hours]	0.39	0.44

2. Secondary Outcome

Title	Subject Reported Postsurgical Pain
Description	11-point numeric rating scale (NRS) (0-10, where 0=no pain, 10=worst possible pain)
Time Frame	1, 2, 6, 12, 24, 48, 72, 96 hours and 10 days after TAP

Outcome Measure Data

Analysis Population Description

Number analyzed in one or more rows differs from overall number analyzed in the instances that participant did not complete the assessment.

Arm/Group Title	EXPAREL 20 mL	EXPAREL 40 mL
Arm/Group Description	Group receiving EXPAREL 20 mL	Group receiving EXPAREL 40 mL
Measure Participants	12	12
1 hour after TAP	4.4 (2.57)	5.3 (2.35)
2 hours after TAP	3.1 (1.5)	3.9 (2.15)
6 hours after TAP	2.4 (1.57)	3.0 (2.10)
12 hours after TAP	2.5 (2.12)	2.2 (1.60)
24 hours after TAP	1.8 (1.75)	2.5 (1.68)
48 hours after TAP	2.0 (1.54)	2.5 (2.61)
72 hours after TAP	1.8 (1.64)	1.9 (1.83)
96 hours after TAP	1.1 (1.08)	1.7 (2.06)
Day 10 after TAP	0.00 (0.00)	1.0 (1.55)

3. Secondary Outcome

Title	Physician/Healthcare Professional Assessed Postsurgical Pain
Description	11-point NRS (0-10, 0=no pain, 10=worst possible pain)
Time Frame	1, 2, 6, 12, 24 hours after TAP

Outcome Measure Data

Analysis Population Description

Number analyzed in one or more rows differs from overall number analyzed in the instances that participant did not complete the assessment.

Arm/Group Title	EXPAREL 20 mL	EXPAREL 40 mL
Arm/Group Description	Group receiving EXPAREL 20 mL	Group receiving EXPAREL 40 mL
Measure Participants	12	12
1 hour after TAP	4.2 (2.33)	5.3 (2.35)
2 hours after TAP	2.9 (1.56)	3.9 (2.15)
6 hours after TAP	2.4 (1.57)	3.0 (2.10)
12 hours after TAP	2.6 (2.07)	2.2 (1.33)
24 hours after TAP	1.8 (1.75)	2.5 (1.68)

4. Secondary Outcome

Title	Total Postsurgical Oxycodone/Acetaminophen Consumption From Hospital Discharge Through Hour 96.
Description	Number of pills
Time Frame	48, 72, 96 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EXPAREL 20 mL	EXPAREL 40 mL
Arm/Group Description	Group receiving EXPAREL 20 mL	Group receiving EXPAREL 40 mL
Measure Participants	12	12
48 hours	1.9 (2.11)	2.2 (2.12)
72 hours	2.8 (3.21)	3.4 (3.75)
96 hours	3.7 (4.25)	4.8 (5.33)

5. Secondary Outcome

Title	Incidence of Prespecified Opioid-related Adverse Events
Description	Number of subjects
Time Frame	Until hospital discharge order was written, anticipated at 24 hours.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EXPAREL 20 mL	EXPAREL 40 mL
Arm/Group Description	Group receiving EXPAREL 20 mL	Group receiving EXPAREL 40 mL
Measure Participants	12	12
Number [Number of subjects]	0	0

6. Secondary Outcome

Title	Overall Rating of Subject Satisfaction With Postsurgical Pain Control
Description	Mean of subject satisfaction offered on a 5-point Likert scale (1 = extremely dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = extremely satisfied)
Time Frame	24 hours, 72 hours, and day 10

Outcome Measure Data

Analysis Population Description

Number analyzed in one or more rows differs from overall number analyzed in the instances that participant did not complete the assessment.

Arm/Group Title	EXPAREL 20 mL	EXPAREL 40 mL
Arm/Group Description	Group receiving EXPAREL 20 mL	Group receiving EXPAREL 40 mL
Measure Participants	12	12
24 hours- satisfied	4 33.3%	5 41.7%
24 hours- extremely satisfied	8 66.7%	7 58.3%
72 hours - satisfied	4 33.3%	4 33.3%
72 hours - extremely satisfied	7 58.3%	7 58.3%
Day 10 - satisfied	3 25%	4 33.3%
Day 10- extremely satisfied	8 66.7%	7 58.3%

Adverse Events

Arm/Group Title	EXPAREL 20 mL		EXPAREL 40 mL
Arm/Group Description	Group receiving EXPAREL 20 mL		Group receiving EXPAREL 40 mL
All Cause Mortality
	EXPAREL 20 mL		EXPAREL 40 mL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	EXPAREL 20 mL		EXPAREL 40 mL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/12 (25%)		0/12 (0%)
General disorders
Pyrexia	1/12 (8.3%)	1	0/12 (0%)	0
Vascular disorders
Post-procedural Hematoma	1/12 (8.3%)	1	0/12 (0%)	0
Pulmonary Embolism	1/12 (8.3%)	1	0/12 (0%)	0
Other (Not Including Serious) Adverse Events
	EXPAREL 20 mL		EXPAREL 40 mL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		1/12 (8.3%)
Musculoskeletal and connective tissue disorders
Joint Stiffness	0/12 (0%)	0	1/12 (8.3%)	1
Joint Swelling	0/12 (0%)	0	1/12 (8.3%)	1

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.