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

Wake Forest University (WFU)

Status and phase: Completed; Phase 4

Conditions: Colorectal Disorders

Treatments: Drug: IV Lidocaine; Drug: Exparel

Study type: Interventional

Funder types: Other

Identifiers

NCT04005859

01-18-16

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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61 participants in 2 patient groups

CONTROL: IV Lido

Active Comparator group

Description:

CONTROL: Intravenous lidocaine, pre- and post-surgery (IV Lido)

Treatment:

Drug: IV Lidocaine

EXPERIMENTAL: Exparel

Experimental group

Description:

EXPERIMENTAL: TAP block with liposomal bupivacaine will be given as an injection (Exparel)

Treatment:

Drug: Exparel