Comparison of Postoperative Analgesic Efficacy of Intravenous Dexketoprofen Trometamol With Tenoxicam

Phase 4

• Conditions: Postoperative Pain
• Interventions: Drug: dexketoprofen trometamol; Drug: serum physiologic; Drug: tenoxicam

• Registration Number: NCT02160236
• Lead Sponsor: TC Erciyes University

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2014-06-08
• Study First Submitted QC: 2014-06-09
• Study First Posted: 2014-06-10
• Status Verified: 2014-11
• Study Start: 2014-11
• Last Update Submitted: 2014-11-07
• Last Update Posted: 2014-11-10
• Primary Completion: 2015-02
• Study Completion: 2015-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexketoprofen trometamol	dexketoprofen trometamol	before end of the surgery via intravenous administration 50 mg dexketoprofen trometamol in 0.9 % NaCl 100 cc
serum physiologic	serum physiologic	before end of the surgery via administration intravenous 0.9 % NaCl 100 cc
tenoxicam	tenoxicam	before the end of the surgery via administration intravenous 20 mg tenoxicam in 0.9% NaCl in 100 cc

Primary Outcome Measures

Name	Time	Method
analgesic consumption	postoperative 1 day	morphine consumption (patient control analgesia procedure) was recorded

Secondary Outcome Measures

Name	Time	Method
visual analog scale	postoperative 1 day	visual analog scale on rest and movement was recorded

Trial Locations

Locations (1)

Erciyes Universty Hospital; 🇹🇷 Kayseri, Turkey