Phase 4
N=65
QL Block With Exparel in Colectomy
Laparotomy · Colectomy
Bottom Line
View on ClinicalTrials.gov: NCT03827291 ↗Enrolled (actual)
65
Serious AEs
1.7%
Results posted
Oct 2025
Primary outcome: Primary: Cumulative Opioid Consumption Over 48 Hours — 33; 61 morphine milligram equivalents
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Exparel (Drug); Thoracic epidural analgesia (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Opioid Consumption Over 48 Hours |
33; 61 | — |
| SECONDARY Pain While Coughing as Measured by 11-point Numeric Rating Scale (NRS-11) |
5; 4; 3; 0; 3; 2 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03827291). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.