Nonopioid Analgesics and Cholecystectomy

NCT ID: NCT04622813

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-08
• Study Completion Date: 2022-10-19

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.

Detailed Description

Nefopam is a centrally-acting anti-nociceptive compound with supraspinal and spinal sites of action. It inhibits monoamine reuptake, modulates descending serotoninergic pain, and may also interact with a dopaminergic pathway. Because its mechanism of action is distinct from that of other analgesic opioids, nefopam may well have a role in analgesic protocols. The role of nefopam in multimodal analgesia has been extensively investigated in laparoscopic cholecystectomy. However, there is general agreement that more studies are needed to determine the ideal multimodal strategy. No previous study has investigated a combination regimen of the three most commonly prescribed non-opioid analgesics (NOA) (nefopam, ketoprofen, and paracetamol) vs ketoprofen and paracetamol combination during sevoflurane-dexmedetomidine based anesthesia on pain control after laparoscopic cholecystectomy.

The aim of our study is to compare a combination regimen of three NOA (nefopam, ketoprofen, and paracetamol) vs ketoprofen and paracetamol combination during sevoflurane-dexmedetomidine based anesthesia on pain control after laparoscopic cholecystectomy. We will try to demonstrate the benefit with the addition of a third NOA, which is the nefopam, to the double-drug regimen including ketoprofen and paracetamol. Our hypothesis is that this combination regimen of three NOA is associated with less postoperative pain, less opioid consumption, shorter length of post-anesthesia care unit (PACU) stay, and fewer opioid-related adverse effects and postoperative complications compared to the double-drug regimen of ketoprofen and paracetamol.

In this prospective randomized double-blind study, 90 patients aged 18 to 64 years, with American Society of Anesthesiologists (ASA) physical status I and II, will be randomly assigned using a computer-generated random number table to one of two treatment groups. Group A will receive sevoflurane-dexmedetomidine based anesthesia with ketoprofen and paracetamol for postoperative pain control, and group B will receive sevoflurane-dexmedetomidine based anesthesia with nefopam, ketoprofen, and paracetamol for postoperative pain control. The primary outcome measure of this study is total morphine consumption in PACU. Normally distributed data will be summarized as mean ± SD and non-normally distributed data will be summarized as median [interquartile range]. This study would have an impact on our current practice and may help find out the best multimodal analgesic strategy to control postoperative pain after laparoscopic cholecystectomy.

Conditions

Cholecystectomy; Pain, Postoperative; Opioid Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo group

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

Group Type: PLACEBO_COMPARATOR

saline infusion, ketoprofen, paracetamol

Intervention Type: 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

Multimodal group

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

Group Type: EXPERIMENTAL

nefopam, ketoprofen, paracetamol

Intervention Type: DRUG

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

Interventions

nefopam, ketoprofen, paracetamol

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

Intervention Type: DRUG

saline infusion, ketoprofen, paracetamol

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

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American University of Beirut Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sahar Sayyid

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sahar Sayyid, MD

Role: PRINCIPAL_INVESTIGATOR

American University of Beirut Medical Center

Locations

American University of Beirut Medical center

Beirut, , Lebanon

Countries

Lebanon

Other Identifiers

BIO-2020-0375

Identifier Type: -

Identifier Source: org_study_id