TAP Block Catheters vs Liposomal Bupivacaine for Pain Control After Colorectal Surgery

• Sponsor: University of California, Davis (Other)
• Overall Status: Completed
• CT.gov ID: NCT03080142
• Collaborator: (none)
• Enrollment: 86
• Location: 1
• Arms: 2
• Actual Duration (Months): 26.9
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief Summary

This is a prospective randomized study designed to compare the pain control from a single shot of liposomal bupivacaine (Exparel) against transversus abominus plane (TAP) catheters with ropivicaine bolus in patients undergoing elective colorectal surgery.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Surgery; TAP Blocks	Drug: Exparel; Drug: Ropivacaine	Phase 4

Detailed Description

At UC Davis, it is standard practice to place TAP blocks with catheters for adult colorectal surgery patients for perioperative pain control. This practice, however, is resource intensive, adds the risk of catheter-related complications, and adds increased burden to patients by requiring them to be tethered to 2 catheters.

An alternative TAP can be performed using a single shot of liposomal bupivacaine (Exparel), an extended release local anesthetic that is FDA-approved for surgical plane infiltration including TAP blocks.

With this prospective study, we seek to improve patient care at UC Davis and educate other institutions through the use of concrete data comparing these 2 treatment options.

Study Design

• Study Type: Interventional
• Actual Enrollment: 86 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Transversus Abdominus Plane (TAP) Block Catheters vs Liposomal Bupivacaine for Pain Control After Colorectal Surgery: A Prospective Randomized Control Trial
• Actual Study Start Date: Mar 1, 2017
• Actual Primary Completion Date: May 29, 2019
• Actual Study Completion Date: May 29, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Single injection of Exparel	Drug: Exparel; Patients will receive an injection of 30ml of volume to each abdominal side with a total of 60 ml for bilateral TAP blocks.; Other Names: Bupivacaine liposome injectable suspension
Active Comparator: Group 2 Injection of Ropivicaine (Naropin) bolus and placement of Ropivicaine catheters	Drug: Ropivacaine; Patients will receive 30ml of ropivicaine. Peripheral nerve catheters will be placed approximately 3-5cm into the TAP space and secured to the skin with tegaderm tape. Infusions will be ordered with CADD pumps and will be initiated at a rate of 8ml/hr of 0.2% ropivicaine on the inpatient floor.; Other Names: Naropin

Outcome Measures

Primary Outcome Measures

1. Mean Opioid Consumption in Morphine Opioid Equivalents in mg [48 hours from start of surgery]

   Anticipate superior efficacy and pain control with liposomal bupivacaine TAP blocks measured by use of opioids (measured in oral morphine equivalents) in the first 48 hours following surgery Will use opioid consumption in morphine equivalents as a comparison

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients scheduled for elective colorectal surgery with Dr. Linda Farkas

Exclusion Criteria:

• Patients under 18 years of age

• Patient over 90 years of age

• Pregnancy

• Prisoners

• Patients unable to provide consent

• Patients on systemic anticoagulation therapy

• Patients with an allergy to local anesthetics

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UC Davis Health	Sacramento	California	United States	95817

Sponsors and Collaborators

• University of California, Davis

Investigators

• Principal Investigator: Jon Zhou, MD, UC Davis Health

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 31, 2017
• Informed Consent Form - Mar 7, 2017

More Information

Publications

None provided.

• Responsible Party: University of California, Davis
• ClinicalTrials.gov Identifier: NCT03080142
• Other Study ID Numbers: 983837
• First Posted: Mar 15, 2017
• Last Update Posted: Apr 27, 2021
• Last Verified: Apr 1, 2021

• 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
• Additional relevant MeSH terms: Bupivacaine; Ropivacaine

Study Results

Participant Flow

Arm/Group Title	Liposomal Bupivacaine Group	Ropivacaine Catheter Group
Arm/Group Description	Single injection of Exparel Exparel: Patients will receive an injection of 30ml of volume to each abdominal side with a total of 60 ml for bilateral TAP blocks.	Injection of Ropivicaine (Naropin) bolus and placement of Ropivicaine catheters Ropivacaine: Patients will receive 30ml of ropivicaine. Peripheral nerve catheters will be placed approximately 3-5cm into the TAP space and secured to the skin with tegaderm tape. Infusions will be ordered with CADD pumps and will be initiated at a rate of 8ml/hr of 0.2% ropivicaine on the inpatient floor.
Period Title: Overall Study
STARTED	42	44
COMPLETED	42	44
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Group 1	Group 2	Total
Arm/Group Description	Single injection of Exparel Exparel: Patients will receive an injection of 30ml of volume to each abdominal side with a total of 60 ml for bilateral TAP blocks.	Injection of Ropivicaine (Naropin) bolus and placement of Ropivicaine catheters Ropivacaine: Patients will receive 30ml of ropivicaine. Peripheral nerve catheters will be placed approximately 3-5cm into the TAP space and secured to the skin with tegaderm tape. Infusions will be ordered with CADD pumps and will be initiated at a rate of 8ml/hr of 0.2% ropivicaine on the inpatient floor.	Total of all reporting groups
Overall Participants	42	44	86
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	57.4	57.1	57.2
Sex: Female, Male (Count of Participants)
Female	21 50%	24 54.5%	45 52.3%
Male	21 50%	20 45.5%	41 47.7%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	42 100%	44 100%	86 100%

Outcome Measures

1. Primary Outcome

Title	Mean Opioid Consumption in Morphine Opioid Equivalents in mg
Description	Anticipate superior efficacy and pain control with liposomal bupivacaine TAP blocks measured by use of opioids (measured in oral morphine equivalents) in the first 48 hours following surgery Will use opioid consumption in morphine equivalents as a comparison
Time Frame	48 hours from start of surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1	Group 2
Arm/Group Description	Single injection of Exparel Exparel: Patients will receive an injection of 30ml of volume to each abdominal side with a total of 60 ml for bilateral TAP blocks.	Injection of Ropivicaine (Naropin) bolus and placement of Ropivicaine catheters Ropivacaine: Patients will receive 30ml of ropivicaine. Peripheral nerve catheters will be placed approximately 3-5cm into the TAP space and secured to the skin with tegaderm tape. Infusions will be ordered with CADD pumps and will be initiated at a rate of 8ml/hr of 0.2% ropivicaine on the inpatient floor.
Measure Participants	42	44
Mean (Standard Deviation) [IV morphine equivalents (mg)]	112.12 (112.8)	97.95 (58.15)

Adverse Events

Time Frame	From study enrollment in the preoperative holding area for 2 hospital days
Adverse Event Reporting Description	No adverse events with patients enrolled in this study
Arm/Group Title	Group 1		Group 2
Arm/Group Description	Single injection of Exparel Exparel: Patients will receive an injection of 30ml of volume to each abdominal side with a total of 60 ml for bilateral TAP blocks.		Injection of Ropivicaine (Naropin) bolus and placement of Ropivicaine catheters Ropivacaine: Patients will receive 30ml of ropivicaine. Peripheral nerve catheters will be placed approximately 3-5cm into the TAP space and secured to the skin with tegaderm tape. Infusions will be ordered with CADD pumps and will be initiated at a rate of 8ml/hr of 0.2% ropivicaine on the inpatient floor.
All Cause Mortality
	Group 1		Group 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/42 (0%)		0/44 (0%)
Serious Adverse Events
	Group 1		Group 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/42 (0%)		0/44 (0%)
Other (Not Including Serious) Adverse Events
	Group 1		Group 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/42 (0%)		0/44 (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.