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

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.

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Key information

Conditions

Colorectal Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Atrium Health - Carolinas Medical Center

Charlotte, North Carolina, 28204, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exparel

Drug

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

Drug

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.

Primary outcomes

Verbal Pain Scale (VRS) - 4 Week Post-op

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Acronym: Exparel

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2021
First posted: Jul 2, 2019
Registry last updated: Aug 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed