CompletedPhase 3

Nonopioid Analgesics and Cholecystectomy

Lebanon90 participantsStarted 2021-04-08

Plain-language summary

The goal of this clinical trial is to evaluate the effect of the addition of nefopam to a multimodal analgesic regimen consisting of ketoprofen and paracetamol during sevoflurane- dexmedetomidine-based anesthesia on postoperative morphine requirements in patients undergoing laparoscopic cholecystectomy.

Who can participate

Age range18 Years – 64 Years

SexALL

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

Inclusion Criteria: * ASA physical status I-II * Age between 18 and 64 years * Patients able to give consent Exclusion Criteria: * ASA physical status III to V * History of chronic pain * Use of an opioid analgesic within 12 hours prior to surgery * Alcohol or drug abuse * Chronic opioid intake * Morbid obesity * Psychiatric disorder * Pregnancy or breast-feeding * Intolerance to NSAIDSs * Allergy or contraindication to nefopam (acute angle-closure glaucoma, epilepsy, coronary artery disease, prostate adenoma), to morphine or paracetamol (liver failure), to ketoprofen (increased risk of bleeding, stomach or intestinal ulcer, chronic kidney disease) or to dexmedetomidine (uncontrolled hypertension, heart block greater than first degree, or other clinically significant morbidities)

What they're measuring

Total morphine consumption in the post anesthesia care unit

Timeframe: Throughout the patient's stay in the recovery room (average of 30 minutes after the surgery)

Trial details

NCT IDNCT04622813

SponsorAmerican University of Beirut Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-19

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