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

Phase 4

Completed

• Conditions: Colorectal Disorders
• Interventions: Drug: IV Lidocaine; Drug: Exparel

• Registration Number: NCT04005859
• Lead Sponsor: Wake Forest University Health Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-22
• Primary Completion: 2019-05-09
• Study First Submitted: 2019-06-27
• Study First Submitted QC: 2019-07-01
• Study First Posted: 2019-07-02
• Study Completion: 2021-07-20
• Results First Submitted: 2021-07-20
• Status Verified: 2021-10
• Results First Submitted QC: 2021-10-20
• Results First Posted: 2021-10-22
• Last Update Submitted: 2022-08-05
• Last Update Posted: 2022-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CONTROL: IV Lido	IV Lidocaine	CONTROL: Intravenous lidocaine, pre- and post-surgery (IV Lido)
EXPERIMENTAL: Exparel	Exparel	EXPERIMENTAL: TAP block with liposomal bupivacaine will be given as an injection (Exparel)

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Atrium Health - Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States