CompletedPhase 4

QL Block With Exparel in Colectomy

United States35 participantsStarted 2019-10-31

Plain-language 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.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cumulative Opioid Consumption Over 48 Hours

Timeframe: From arrival to PACU to 48 hours post-operatively

Trial details

NCT IDNCT03827291

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-02

Results submitted2023-06-22

View on ClinicalTrials.gov More Laparotomy trials