Postoperative Analgesia in Laminectomy

Phase 4

• Conditions: Postoperative Laminectomy Pain; Postoperative Pain
• Interventions: Drug: 300 mg paracetamol and 30 mg codeine; Drug: placebo tablet; Drug: 550 mg naproxen sodium and 30mg codeine

• Registration Number: NCT02255955
• Lead Sponsor: Diskapi Yildirim Beyazit Education and Research Hospital

Brief Summary

Compare the analgesic effects of naproxen sodium codeine, paracetamol codeine and placebo on postoperative pain and tramadol (Contramal) consumption during the first 24 hour after a lumbar disk surgery.

Detailed Description

Compare the analgesic effects of naproxen sodium codeine paracetamol codeine and placebo on postoperative pain intensity measured by the visual analogue scale, and evaluated tramadol consumption and related side effects.

Study Timeline

• Study First Submitted: 2014-09-27
• Study Start: 2014-10
• Study First Submitted QC: 2014-10-02
• Study First Posted: 2014-10-03
• Status Verified: 2014-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-25
• Last Update Posted: 2014-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• American Society of Anesthesiologists (ASA) 1 or 2 status patients scheduled for an elective lumbar disc surgery

Exclusion Criteria

• were known allergies to any of the drugs used in this study
• peptic ulcer disease
• hepatic and renal dysfunction,
• emergency surgery
• inability to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
300 mg paracetamol and 30 mg codeine	300 mg paracetamol and 30 mg codeine	Preoperatively patients received oral paracetamol codeine, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS.
Placebo	placebo tablet	Preoperatively patients received oral placebo tablet, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS.
550 mg naproxen sodium and 30mg codeine	550 mg naproxen sodium and 30mg codeine	Preoperatively patients received oral naproxen sodium codeine, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS.

Primary Outcome Measures

Name	Time	Method
Contramal consumption	Postoperative 24 hour	To assess contramal consumption

Secondary Outcome Measures

Name	Time	Method
Side effects	postoperative 24 hour	nausea and vomiting
Pain intensity	postoperative 24 hour	To assess postoperative pain intensity by visual analog scale