Colorectal Disorders
Conditions
Brief summary
To compare the analgesic impact of intravenous perioperative lidocaine infusion with preoperative liposomal bupivacaine TAP block in colorectal surgery. This is to be integrated into the standard ERAS protocol currently utilized at Carolinas Medical Center. Primary endpoints will be postoperative pain as measured by verbal rate scale (VRS), postoperative morphine equivalents utilized per day, and over 30 days. Secondary endpoints will include date of ambulation, return of bowel function (first flatus), tolerance of goal diet, incidence of post-operative nausea and vomiting during hospital stay, length of stay (hospital and PACU), post-operative morbidity (Clavien-Dindo, related to both anesthesia and surgery), cost of hospitalization (operative, PACU, postoperative stay, and total) and quality of life on follow up.
Interventions
DRUGExparel
2\. Liposomal bupivacaine TAP block (experimental arm) 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.
DRUGIV Lidocaine
1\. Intravenous Lidocaine infusion (control arm, current standard of care) 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.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-75 years * Elective laparoscopic colorectal surgery * ASA I-III
Exclusion criteria
* Contraindication to Na Channel Blocker * Chronic Opioid use * Liver dysfunction * Renal insufficiency * Epilepsy * Psychomotor retardation * BMI \>40 * Sleep Apnea * Cardiac Rhythm Disorders * Planned open or concomitant procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Verbal Pain Scale (VRS) - 4 Week Post-op | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 28 |
| 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. | 25 |
| Total | 53 |
Baseline characteristics
| Characteristic | CONTROL: IV Lido | EXPERIMENTAL: Exparel | Total |
|---|---|---|---|
| Age, Continuous | 54.6 years STANDARD_DEVIATION 16.2 | 55.8 years STANDARD_DEVIATION 14 | 55.4 years STANDARD_DEVIATION 15.2 |
| BMI | 27.7 kg/m^2 STANDARD_DEVIATION 5.3 | 29.6 kg/m^2 STANDARD_DEVIATION 8.2 | 28.4 kg/m^2 STANDARD_DEVIATION 7 |
| Current Tobacco Use | 7 Participants | 6 Participants | 13 Participants |
| H/O Diabetes | 3 Participants | 6 Participants | 9 Participants |
| On Steroids | 4 Participants | 1 Participants | 5 Participants |
| Prior intra-abdominal surgery | 5 Participants | 9 Participants | 14 Participants |
| Procedure was robotic-assisted | 14 Participants | 9 Participants | 23 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 9 Participants | 16 Participants | 25 Participants |
| Sex: Female, Male Male | 19 Participants | 9 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 25 |
| other Total, other adverse events | 0 / 28 | 0 / 25 |
| serious Total, serious adverse events | 0 / 28 | 0 / 25 |
Outcome results
Primary
Verbal Pain Scale (VRS) - 4 Week Post-op
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.
Time frame: Single VRS assessed at 4-week post-op visit (or phone call)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CONTROL: IV Lido | Verbal Pain Scale (VRS) - 4 Week Post-op | 0.4 score on a scale | Standard Deviation 0.7 |
| EXPERIMENTAL: Exparel | Verbal Pain Scale (VRS) - 4 Week Post-op | 1.1 score on a scale | Standard Deviation 2 |