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

NCT04005859 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 01-18-16
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

CONTROL: IV Lido

ACTIVE COMPARATOR

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

Drug: IV Lidocaine

EXPERIMENTAL: Exparel

EXPERIMENTAL

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

Drug: Exparel

Interventions

Exparel 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.

EXPERIMENTAL: Exparel

IV Lidocaine 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.

CONTROL: IV Lido

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years
• Elective laparoscopic colorectal surgery
• ASA I-III

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Atrium Health - Carolinas Medical Center

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

1. Opioid consumption was quite varied amongst patients, possibly contributing to underpowered study. 2. Inconsistent recording of VAS while inpatient 3. Inconsistent recording of VAS while undergoing 2 and 4 week post-op follow-up (clinic vs phone) 4. Difficult to completely account for OME based on potential for outside prescriptions not seen by researchers.

Results Point of Contact

• Title: Dr. Kevin Kasten
• Organization: Atrium Health

kevin.kasten@atriumhealth.org

704-355-1813

Study Officials

• Kevin Kasten, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 2, 2019
• Study Start: February 22, 2018
• Primary Completion: May 9, 2019
• Study Completion: July 20, 2021
• Last Updated: August 9, 2022
• Results First Posted: October 22, 2021

Record last verified: 2021-10

Locations

US (1)