Nonopioid Analgesics and Cholecystectomy
Condition: Cholecystectomy; Pain, Postoperative; Opioid Use
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): nefopam, ketoprofen, paracetamol; saline infusion, ketoprofen, paracetamol
Intervention type(s): Drug; Drug
Intervention description(s): Patients in this group will receive Nefopam and Ketoprofen in addition to the paracetamol intraoperatively prior to the anticipated end of the surgery; 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 MeSH terms: Acetaminophen; Ketoprofen; Nefopam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment