Efficacy Parecoxib and Ketorolac as Preemptive Analgesia in Spine Fusion

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Parecoxib; Drug: Ketorolac

• Registration Number: NCT01859585
• Lead Sponsor: Prince of Songkla University

Brief Summary

The purpose of this study is to evaluate the efficacy of Parecoxib and Ketorolac as a preemptive analgesia in patients undergoing lumbar spinal fusion.

Detailed Description

A prospective, double-blinded randomized control trial. Randomly allocated patient undergoing posterior lumbar spinal fusion into 3 groups (n=32) to receive Parecoxib, Ketorolac and Placebo around 30 minutes prior to incised skin. Efficacy was assessed by visual analog scale score (0-10), total opioid consumption, complication and bleeding also recorded.

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2013-01
• Study Completion: 2013-03
• Status Verified: 2013-05
• Study First Submitted: 2013-05-15
• Study First Submitted QC: 2013-05-21
• Last Update Submitted: 2013-05-21
• Study First Posted: 2013-05-22
• Last Update Posted: 2013-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• Patients undergoing lumbar spinal fusion for one to three levels
• ASA class I or II

Exclusion Criteria

• History of allergy to Sulfa group
• History of allergy to OPOID or NSAIDs
• Contraindicate to NSAIDs use
• History of coagulopathy or platelet disfunction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parecoxib	Parecoxib	Parecoxib
Ketorolac	Ketorolac	Ketorolac

Primary Outcome Measures

Name	Time	Method
Pain score	Postoperative time up to 24 hours	recorded as Verbal Numerical Rating Scare 0-10

Secondary Outcome Measures

Name	Time	Method
Total amount of opioid consumption postoperatively	Postoperative 24 hours

Trial Locations

Locations (1)

Faculty of Medicine, Prince of Songkla University; 🇹🇭 Hadyai, Sonkla, Thailand