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

NCT ID: NCT04005859

Last Updated: 2022-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-22
• Study Completion Date: 2021-07-20

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.

Conditions

Colorectal Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CONTROL: IV Lido

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

Group Type: ACTIVE_COMPARATOR

IV Lidocaine

Intervention Type: DRUG

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.

EXPERIMENTAL: Exparel

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

Group Type: EXPERIMENTAL

Exparel

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin Kasten, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Atrium Health - Carolinas Medical Center

Charlotte, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

01-18-16

Identifier Type: -

Identifier Source: org_study_id