Comparison of Postoperative Analgesic Efficacy of Intravenous Dexketoprofen Trometamol With Tenoxicam

Comparison of Postoperative Analgesic Efficacy of Intravenous Dexketoprofen Trometamol With Tenoxicam in Lumbar Disc Surgery

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

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: dexketoprofen trometamol; Drug: tenoxicam; Drug: serum physiologic

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Kayseri, Turkey, 38039
    • Recruiting
    • Erciyes Universty Hospital
    • Contact: nazife küçük, resident; Phone Number: +905072317446; Email: nzfkucuk@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: dexketoprofen trometamol; before end of the surgery via intravenous administration 50 mg dexketoprofen trometamol in 0.9 % NaCl 100 cc	Drug: dexketoprofen trometamol; before end of the surgery via intravenous administration 50 mg dexketoprofen trometamol in 0.9 % NaCl 100 cc; Other Names: arveles
Active Comparator: tenoxicam; before the end of the surgery via administration intravenous 20 mg tenoxicam in 0.9% NaCl in 100 cc	Drug: tenoxicam; before the end of the surgery via administration intravenous 20 mg tenoxicam in 0.9% NaCl in 100 cc; Other Names: oksamen
Placebo Comparator: serum physiologic; before end of the surgery via administration intravenous 0.9 % NaCl 100 cc	Drug: serum physiologic; before end of the surgery via administration intravenous 0.9 % NaCl 100 cc

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
analgesic consumption	morphine consumption (patient control analgesia procedure) was recorded	postoperative 1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analog scale	visual analog scale on rest and movement was recorded	postoperative 1 day

Collaborators and Investigators

• Sponsor: TC Erciyes University
• Investigators: Principal Investigator: nazife küçük, resident, TC Erciyes University

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): February 1, 2015
• Study Completion (Anticipated): February 1, 2015

Study Registration Dates

• First Submitted: June 8, 2014
• First Submitted That Met QC Criteria: June 9, 2014
• First Posted (Estimate): June 10, 2014

Study Record Updates

• Last Update Posted (Estimate): November 10, 2014
• Last Update Submitted That Met QC Criteria: November 7, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: postoperative pain; dexketoprofen trometamol; tenoxicam
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Dexketoprofen trometamol; Tenoxicam
• Other Study ID Numbers: 2013/469