NCT04005859

Pain Control in Colorectal Surgery: Liposomal Bupivacaine Block Versus Intravenous Lidociane

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Colorectal Disorders

Interventions

Type	Name	Description
DRUG	Exparel	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.
DRUG	IV 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.

Timeline

• Start date: 2018-02-22
• Primary completion: 2019-05-09
• Completion: 2021-07-20
• First posted: 2019-07-02
• Last updated: 2022-08-09
• Results posted: 2021-10-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study