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Trial Outcomes & Findings for TAP Block Catheters vs Liposomal Bupivacaine for Pain Control After Colorectal Surgery (NCT NCT03080142)

NCT ID: NCT03080142

Last Updated: 2021-04-27

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

86 participants

Primary outcome timeframe

48 hours from start of surgery

Results posted on

2021-04-27

Participant Flow

Participant milestones

Participant milestones
Measure
Liposomal Bupivacaine Group
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.
Ropivacaine Catheter Group
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.
Overall Study
STARTED
42
44
Overall Study
COMPLETED
42
44
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Group 1
n=42 Participants
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.
Group 2
n=44 Participants
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
n=86 Participants
Total of all reporting groups
Age, Continuous
57.4 years
n=42 Participants
57.1 years
n=44 Participants
57.2 years
n=86 Participants
Sex: Female, Male
Female
21 Participants
n=42 Participants
24 Participants
n=44 Participants
45 Participants
n=86 Participants
Sex: Female, Male
Male
21 Participants
n=42 Participants
20 Participants
n=44 Participants
41 Participants
n=86 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
United States
42 participants
n=42 Participants
44 participants
n=44 Participants
86 participants
n=86 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure
Group 1
n=42 Participants
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.
Group 2
n=44 Participants
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.
Mean Opioid Consumption in Morphine Opioid Equivalents in mg
112.12 IV morphine equivalents (mg)
Standard Deviation 112.8
97.95 IV morphine equivalents (mg)
Standard Deviation 58.15

Adverse Events

Group 1

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Group 2

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jon Zhou MD

UC Davis Medical Center, Department of Anesthesiology

Phone: 9167035028

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place