Intraoperative Use of Dexketoprofen Trometamol, Pethidine Hcl, Tramadol Hcl and Their Combinations for Postoperative Pain Management in Laparoscopic Nissen Fundoplication

Overview

The purpose of this study is to evaluate the analgesic effects of dexketoprofen trometamol, tramadol hydrochloride, pethidine hydrochloride and their combinations in laparoscopic Nissen fundoplication.

Full Title of Study: “Intraoperative Use of Dexketoprofen Trometamol, Tramadol Hcl, Pethidine Hcl and Their Combinations for Postoperative Pain Management in Laparoscopic Nissen Fundoplication”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: May 2012

Interventions

  • Drug: dexketoprofen trometamol
    • 50mg intravenous infusion
  • Drug: tramadol hydrochloride
    • 100mg intravenous infusion
  • Drug: pethidine hydrochloride
    • 50mg intravenous infusion
  • Drug: dexketoprofen trometamol + tramadol hydrochloride
    • intravenous infusion of 50mg dexketoprofen trometamol + 100mg tramadol hydrochloride
  • Drug: dexketoprofen trometamol + pethidine hydrochloride
    • intravenous infusion of 50mg dexketoprofen trometamol + 50mg pethidine hydrochloride
  • Drug: vitamin c
    • 500mg intravenous infusion

Arms, Groups and Cohorts

  • Placebo Comparator: dexketoprofen trometamol
    • Dexketoprofen trometamol is a water-soluble salt of the dextrorotatory enantiomer of the nonsteroidal anti-inflammatory drug (NSAID) ketoprofen.
  • Placebo Comparator: tramadol hydrochloride
    • Tramadol Hydrochloride is a well-known centrally acting opioid pain killer.
  • Placebo Comparator: pethidine hydrochloride
    • Pethidine is a synthetic opioid analgesic which produces a pattern of effects similar to morphine the standard against which opioid analgesics are compared.
  • Placebo Comparator: dexketoprofen trometamol + tramadol hydrochloride
  • Placebo Comparator: dexketoprofen trometamol + pethidine hydrochloride
  • Placebo Comparator: vitamin c

Clinical Trial Outcome Measures

Primary Measures

  • Allergic reactions to NSAIDs or opioid analgesics, body mass index exceeding 35
    • Time Frame: postoperative 2 hours

Participating in This Clinical Trial

Inclusion Criteria

  • 18-60 years old ASA I-II patients – Clinical diagnosis of gastroesophageal reflux patients Exclusion Criteria:

  • Allergic reactions to NSAIDs or opioid analgesics – Body mass index exceeding 35 – Pregnancy

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kavaklıdere Umut Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: GOKHAN GOKMEN, Anesthesiologist, MD – Kavaklıdere Umut Hospital
  • Overall Official(s)
    • GOKHAN GOKMEN, Specialist, Principal Investigator,

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