QL Block With Exparel in Colectomy

Phase 4

Completed

• Conditions: Colectomy; Laparotomy
• Interventions: Other: Thoracic epidural analgesia; Drug: Exparel

• Registration Number: NCT03827291
• Lead Sponsor: Duke University

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.

Study Timeline

• Study First Submitted: 2019-01-31
• Study First Submitted QC: 2019-01-31
• Study First Posted: 2019-02-01
• Study Start: 2019-10-31
• Status Verified: 2022-12
• Primary Completion: 2022-12-02
• Study Completion: 2022-12-09
• Last Update Submitted: 2022-12-19
• Last Update Posted: 2022-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thoracic epidural analgesia	Thoracic epidural analgesia	Historical cohort that received thoracic epidural analgesia.
Quadratus lumborum block	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.

Primary Outcome Measures

Name	Time	Method
Cumulative opioid consumption over 48 hours	Opioid consumption from administration of Exparel to 48 hours post-administration	Opioid consumption from administration of Exparel to 48 hours post-administration

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States