QL Block With Exparel in Colectomy

NCT ID: NCT03827291

Last Updated: 2025-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-31
• Study Completion Date: 2022-12-09

Brief Summary

The purpose of this study is to determine if using a different type of injection of local anesthestic (pain medicine) in between the muscle layers of the abdominal wall (called a quadratus lumborum block) will improve pain control and be easier to manage after surgery than the current standard of care epidural (spinal injection) pain relief for patients undergoing laparoscopy colectomy.

Detailed Description

Participants in this study will receive exparel via an abdominal muscle nerve block procedure immediately prior to their operation. Participants will be in this study for 96 hours following surgery, which is typically 3 days. During participation, the study staff will review participant's electronic health records for pain scores and pain medication needs.

Participants that receive the quadratus lumborum block, may experience improved pain control and/or reduced side effects compared to the epidural pain relief option, but it is not known yet whether this will be the case.

The most common risk is being sore in the flank where the block was placed. Other risks of the block rarely occur (less than .5-1%), these can include infection, allergy to the local anesthetic, bleeding, damage to the nerve, seizures, abnormal heart rhythms, and cardiac arrest.

Conditions

Laparotomy; Colectomy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Quadratus lumborum block

Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.

Group Type: EXPERIMENTAL

Exparel

Intervention Type: DRUG

Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.

Thoracic epidural analgesia

Historical cohort that received thoracic epidural analgesia.

Group Type: OTHER

Thoracic epidural analgesia

Intervention Type: OTHER

Historical cohort that received thoracic epidural analgesia

Interventions

Exparel

Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.

Intervention Type: DRUG

Thoracic epidural analgesia

Historical cohort that received thoracic epidural analgesia

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients scheduled for elective, laparoscopic colonic resection by one of three surgeons: Drs. Thacker, Mantyh or Migaly. These surgeons perform this procedure in the same manner
• Age 18-85 years
• American Society of Anesthesiologists (ASA) Physical Class I-III
• BMI 18-35 kg/m^2

Exclusion Criteria

• Inability to consent
• Inability to speak English
• Pregnancy
• Emergency surgery
• Contraindications to regional blockade: coagulopathy or bleeding diathesis, local infection, allergy to local anesthetics
• Allergies/intolerances/contraindications to any of the multimodal agents (acetaminophen, gabapentin, ketorolac)
• Daily opioid equivalent use of 30 mg of morphine or greater at time of consent
• History of drug or alcohol abuse
• Rheumatoid arthritis
• Uncontrolled anxiety, schizophrenia or other psychiatric disorder that, in the opinion of the investigator, may interfere with the study assessments of compliance

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pacira Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amanda Kumar, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PRO00091425

Identifier Type: -

Identifier Source: org_study_id