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

Colorectal Disorders Clinical Trial

— Exparel  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04005859
• Other study ID #: 01-18-16
• Status: Completed
• Phase: Phase 4
• Start date: February 22, 2018
• Est. completion date: July 20, 2021

Study information

• Verified date: October 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: July 20, 2021
• Est. primary completion date: May 9, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Disorders

Intervention

Drug:
• Exparel
2. Liposomal bupivacaine TAP block (experimental arm) Block will be administered after induction of anesthesia and before incision by a specifically trained attending surgeon or surgical fellow with the colorectal service. 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. The LB will be administered under ultrasound guidance in the transversus abdominis plain per manufacturer recommendations. Adhesive tapes will be applied at the level of the TAP block puncture sites.
• IV Lidocaine
1. Intravenous Lidocaine infusion (control arm, current standard of care) 100 mg/5mL intravenous bolus of lidocaine 2% PF 5mL will be initiated by anesthesia service prior to general anesthesia induction. 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. Adhesive tapes will be applied at the presumed level of TAP block puncture sites.

Locations

Country	Name	City	State
United States	Atrium Health - Carolinas Medical Center	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Single VRS assessed at 4-week post-op visit (or phone call)