Comparison of Postoperative Analgesic Efficacy of Intravenous Dexketoprofen Trometamol With Tenoxicam

Overview

In this study the investigators aimed to compare of postoperative analgesic effects of intravenous dexketoprofen trometamol and tenoxicam in lumbar disc surgery.

Full Title of Study: “Comparison of Postoperative Analgesic Efficacy of Intravenous Dexketoprofen Trometamol With Tenoxicam in Lumbar Disc Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 2015

Detailed Description

Lumbar disc surgery is associated with moderate to severe back and radicular pain postoperatively which has unfavorable effects on patients recovery and procedures outcome. Dexketoprofen has been reported to be one of the NSAİDs that can provide good results when compared with narcotics in many painful conditions and especially in the treatment of the moderate to severe postoperative pain that may develop after lumbal disc surgery. Tenoxicam is a thienothiazine derivative of the oxicam class of NSAİDs. There are some studies in which NSAİDs have been used to together with opioids for postoperative analgesia showing that they decrease opioid consumption and side effects

Interventions

  • Drug: dexketoprofen trometamol
    • before end of the surgery via intravenous administration 50 mg dexketoprofen trometamol in 0.9 % NaCl 100 cc
  • Drug: tenoxicam
    • before the end of the surgery via administration intravenous 20 mg tenoxicam in 0.9% NaCl in 100 cc
  • Drug: serum physiologic
    • before end of the surgery via administration intravenous 0.9 % NaCl 100 cc

Arms, Groups and Cohorts

  • Active Comparator: dexketoprofen trometamol
    • before end of the surgery via intravenous administration 50 mg dexketoprofen trometamol in 0.9 % NaCl 100 cc
  • Active Comparator: tenoxicam
    • before the end of the surgery via administration intravenous 20 mg tenoxicam in 0.9% NaCl in 100 cc
  • Placebo Comparator: serum physiologic
    • before end of the surgery via administration intravenous 0.9 % NaCl 100 cc

Clinical Trial Outcome Measures

Primary Measures

  • analgesic consumption
    • Time Frame: postoperative 1 day
    • morphine consumption (patient control analgesia procedure) was recorded

Secondary Measures

  • visual analog scale
    • Time Frame: postoperative 1 day
    • visual analog scale on rest and movement was recorded

Participating in This Clinical Trial

Inclusion Criteria

  • ASA 1-2
  • between 18-65 age
  • elective lumbar disc surgery

Exclusion Criteria

  • history of gastrointestinal bleeding
  • peptic ulcer disease
  • bleeding disorders
  • history of allergic reactions to NSAİDs
  • chronic pain syndrome

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • TC Erciyes University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Nazife Küçük, resident – TC Erciyes University
  • Overall Official(s)
    • nazife küçük, resident, Principal Investigator, TC Erciyes University
  • Overall Contact(s)
    • Nazife Küçük, resident, +905072317446, nzfkucuk@hotmail.com

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