Trial Outcomes & Findings for Pain Control in Colorectal Surgery: Liposomal Bupivacaine Block Versus Intravenous Lidociane (NCT NCT04005859)
NCT ID: NCT04005859
Last Updated: 2022-08-09
Results Overview
Postoperative pain was measured by verbal rate scale (VRS) Scale of 0-10 at instance of 4-week post-op visit (or phone call). 0 represents no pain while 10 represents worst possible pain.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
61 participants
Primary outcome timeframe
Single VRS assessed at 4-week post-op visit (or phone call)
Results posted on
2022-08-09
Participant Flow
Participant milestones
| Measure |
CONTROL: IV Lido
CONTROL: Intravenous lidocaine, pre- and post-surgery (IV Lido)
IV Lidocaine: 1. Intravenous Lidocaine infusion (control arm, current standard of care) n= 35
1. 100 mg/5mL intravenous bolus of lidocaine 2% PF 5mL will be initiated by anesthesia service prior to general anesthesia induction.
2. 1.5 mg/kg/hr to begin prior to incision and continue until discontinued 1 hr postoperatively in PACU. Patients will be monitored in PACU for at least 30 minutes after discontinuation of lidocaine drip.
3. Adhesive tapes will be applied at the presumed level of TAP block puncture sites.
|
EXPERIMENTAL: Exparel
EXPERIMENTAL: TAP block with liposomal bupivacaine will be given as an injection (Exparel)
Exparel: 2. Liposomal bupivacaine TAP block (experimental arm) n= 35
1. Block will be administered after induction of anesthesia and before incision by a specifically trained attending surgeon or surgical fellow with the colorectal service.
2. A single vial of liposomal bupivacaine (20 mL 1.3%, 13.3mg/mL, 266 mg) will be diluted in 50cc bupivacaine to a volume of 60cc prior to administration. This will be divided into 2 doses for bilateral TAP blocks.
3. The LB will be administered under ultrasound guidance in the transversus abdominis plain per manufacturer recommendations.
4. Adhesive tapes will be applied at the level of the TAP block puncture sites.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
29
|
|
Overall Study
COMPLETED
|
28
|
25
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
CONTROL: IV Lido
n=28 Participants
CONTROL: Intravenous lidocaine, pre- and post-surgery (IV Lido)
IV Lidocaine: 1. Intravenous Lidocaine infusion (control arm, current standard of care) n= 35
1. 100 mg/5mL intravenous bolus of lidocaine 2% PF 5mL will be initiated by anesthesia service prior to general anesthesia induction.
2. 1.5 mg/kg/hr to begin prior to incision and continue until discontinued 1 hr postoperatively in PACU. Patients will be monitored in PACU for at least 30 minutes after discontinuation of lidocaine drip.
3. Adhesive tapes will be applied at the presumed level of TAP block puncture sites.
|
EXPERIMENTAL: Exparel
n=25 Participants
EXPERIMENTAL: TAP block with liposomal bupivacaine will be given as an injection (Exparel)
Exparel: 2. Liposomal bupivacaine TAP block (experimental arm) n= 35
1. Block will be administered after induction of anesthesia and before incision by a specifically trained attending surgeon or surgical fellow with the colorectal service.
2. A single vial of liposomal bupivacaine (20 mL 1.3%, 13.3mg/mL, 266 mg) will be diluted in 50cc bupivacaine to a volume of 60cc prior to administration. This will be divided into 2 doses for bilateral TAP blocks.
3. The LB will be administered under ultrasound guidance in the transversus abdominis plain per manufacturer recommendations.
4. Adhesive tapes will be applied at the level of the TAP block puncture sites.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.6 years
STANDARD_DEVIATION 16.2 • n=28 Participants
|
55.8 years
STANDARD_DEVIATION 14 • n=25 Participants
|
55.4 years
STANDARD_DEVIATION 15.2 • n=53 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=28 Participants
|
16 Participants
n=25 Participants
|
25 Participants
n=53 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=28 Participants
|
9 Participants
n=25 Participants
|
28 Participants
n=53 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
BMI
|
27.7 kg/m^2
STANDARD_DEVIATION 5.3 • n=28 Participants
|
29.6 kg/m^2
STANDARD_DEVIATION 8.2 • n=25 Participants
|
28.4 kg/m^2
STANDARD_DEVIATION 7.0 • n=53 Participants
|
|
On Steroids
|
4 Participants
n=28 Participants
|
1 Participants
n=25 Participants
|
5 Participants
n=53 Participants
|
|
H/O Diabetes
|
3 Participants
n=28 Participants
|
6 Participants
n=25 Participants
|
9 Participants
n=53 Participants
|
|
Current Tobacco Use
|
7 Participants
n=28 Participants
|
6 Participants
n=25 Participants
|
13 Participants
n=53 Participants
|
|
Prior intra-abdominal surgery
|
5 Participants
n=28 Participants
|
9 Participants
n=25 Participants
|
14 Participants
n=53 Participants
|
|
Procedure was robotic-assisted
|
14 Participants
n=28 Participants
|
9 Participants
n=25 Participants
|
23 Participants
n=53 Participants
|
PRIMARY outcome
Timeframe: Single VRS assessed at 4-week post-op visit (or phone call)Postoperative pain was measured by verbal rate scale (VRS) Scale of 0-10 at instance of 4-week post-op visit (or phone call). 0 represents no pain while 10 represents worst possible pain.
Outcome measures
| Measure |
CONTROL: IV Lido
n=28 Participants
CONTROL: Intravenous lidocaine, pre- and post-surgery (IV Lido)
IV Lidocaine: 1. Intravenous Lidocaine infusion (control arm, current standard of care) n= 35
1. 100 mg/5mL intravenous bolus of lidocaine 2% PF 5mL will be initiated by anesthesia service prior to general anesthesia induction.
2. 1.5 mg/kg/hr to begin prior to incision and continue until discontinued 1 hr postoperatively in PACU. Patients will be monitored in PACU for at least 30 minutes after discontinuation of lidocaine drip.
3. Adhesive tapes will be applied at the presumed level of TAP block puncture sites.
|
EXPERIMENTAL: Exparel
n=25 Participants
EXPERIMENTAL: TAP block with liposomal bupivacaine will be given as an injection (Exparel)
Exparel: 2. Liposomal bupivacaine TAP block (experimental arm) n= 35
1. Block will be administered after induction of anesthesia and before incision by a specifically trained attending surgeon or surgical fellow with the colorectal service.
2. A single vial of liposomal bupivacaine (20 mL 1.3%, 13.3mg/mL, 266 mg) will be diluted in 50cc bupivacaine to a volume of 60cc prior to administration. This will be divided into 2 doses for bilateral TAP blocks.
3. The LB will be administered under ultrasound guidance in the transversus abdominis plain per manufacturer recommendations.
4. Adhesive tapes will be applied at the level of the TAP block puncture sites.
|
|---|---|---|
|
Verbal Pain Scale (VRS) - 4 Week Post-op
|
0.4 score on a scale
Standard Deviation 0.7
|
1.1 score on a scale
Standard Deviation 2.0
|
Adverse Events
CONTROL: IV Lido
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
EXPERIMENTAL: Exparel
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place