Nonopioid Analgesics and Cholecystectomy

NCT04622813 | Completed Phase 3

• 1 other identifier: BIO-2020-0375
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cholecystectomy; Pain, Postoperative; Opioid Use

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption in the post anesthesia care unit

  Total morphine doses consumed after the surgery during the post anesthesia care unit stay of the patient

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

Secondary Outcomes (24)

• Total fentanyl

  Intraoperatively

• Total morphine

  Throughout the patient's stay on the floor

• Ketoprofen consumption

  Throughout the patient's stay on the floor

• Paracetamol consumption

  Throughout the patient's stay on the floor

• Total morphine consumption at 24 hours after surgery

  24 hours after surgery

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

Patients received sevoflurane-dexmedetomidine-based anesthesia with saline, ketoprofen and paracetamol for postoperative pain control,

Drug: saline infusion, ketoprofen, paracetamol

Multimodal group

EXPERIMENTAL

patients received sevoflurane-dexmedetomidine-based anesthesia with nefopam, ketoprofen, and paracetamol for postoperative pain control.

Drug: nefopam, ketoprofen, paracetamol

Interventions

nefopam, ketoprofen, paracetamol DRUG

Patients in this group will receive Nefopam and Ketoprofen in addition to the paracetamol intraoperatively prior to the anticipated end of the surgery

Multimodal group

saline infusion, ketoprofen, paracetamol DRUG

Patients in this group will receive one placebo infusion (saline infusion) in addition to the ketoprofen and paracetamol intraoperatively prior to the anticipated end of the surgery

Placebo group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA physical status I-II
• Age between 18 and 64 years
• Patients able to give consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut Medical center

Beirut, Lebanon

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Nefopam; Ketoprofen; Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oxazocines; Azocines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Sahar Sayyid, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 30, 2020
• First Posted: November 10, 2020
• Study Start: April 8, 2021
• Primary Completion: October 19, 2022
• Study Completion: October 19, 2022
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)