QL Block With Exparel in Colectomy

NCT03827291 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: PRO00091425
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparotomy; Colectomy

Outcome Measures

Primary Outcomes (1)

• Cumulative Opioid Consumption Over 48 Hours

  Measured in morphine milligram equivalents.

  From arrival to PACU to 48 hours post-operatively

Secondary Outcomes (1)

• Pain While Coughing as Measured by 11-point Numeric Rating Scale (NRS-11)

  30 minutes after arrival to Post-Anesthesia Care Unit (PACU), and at 8 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours and 168 hours post Exparel administration

Other Outcomes (8)

• Number of Participants With Block Success

  30 minutes after arrival to PACU, 8 hours, 24 hours, 36 hours, 48 hours and 72 hours post Exparel administration

• Number of Participants With Adverse Events Related to the Block

  From administration of Exparel through 168 hours post Exparel administration

• Satisfaction With Postoperative Pain Control

  Up to 48 hours post Exparel administration

Study Arms (2)

Quadratus lumborum block

EXPERIMENTAL

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.

Drug: Exparel

Thoracic epidural analgesia

OTHER

Historical cohort that received thoracic epidural analgesia.

Other: Thoracic epidural analgesia

Interventions

Exparel 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.

Quadratus lumborum block

Thoracic epidural analgesia OTHER

Historical cohort that received thoracic epidural analgesia

Thoracic epidural analgesia

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Pacira Pharmaceuticals, Inc: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Interventions

Tea

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Amanda Kumar, MD
• Organization: Duke University

amanda.kumar@duke.edu

919-681-6437

Study Officials

• Amanda Kumar, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Compare efficacy of a quadratus lumborum block performed with liposomal bupivacaine for pain relief after laparoscopic colectomy compared to a historical cohort who received thoracic epidural analgesia.

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: February 1, 2019
• Study Start: October 31, 2019
• Primary Completion: December 2, 2022
• Study Completion: December 9, 2022
• Last Updated: October 16, 2025
• Results First Posted: October 16, 2025

Record last verified: 2025-09

Locations

US (1)