Efficacy Parecoxib and Ketorolac as Preemptive Analgesia in Spine Fusion

May 21, 2013 updated by: KOOPONG SIRIBUMRUNGWONG, MD, Prince of Songkla University

Comparing the Efficacy of Parecoxib and Ketorolac as Preemptive Analgesia in Patients Undergoing Posterior Lumbar Spinal Fusion

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Sonkla
      • Hadyai, Sonkla, Thailand, 90110
        • Faculty of Medicine, Prince of Songkla University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Parecoxib
Drug: Parecoxib
Parecoxib 40 mg intravenous
Other Names:
  • Dynastat
EXPERIMENTAL: Ketorolac
Drug: Ketorolac
Ketorolac 30 mg intravenous
Other Names:
  • Ketolac
NO_INTERVENTION: No medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: Postoperative time up to 24 hours
recorded as Verbal Numerical Rating Scare 0-10
Postoperative time up to 24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Total amount of opioid consumption postoperatively
Time Frame: Postoperative 24 hours
Postoperative 24 hours

Other Outcome Measures

Outcome Measure
Time Frame
Amount of drain output and Other Adverse effect
Time Frame: 7 days postoperatively
7 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prince of Songkla University

Investigators

  • Principal Investigator: Koopong Siribumrungwong, MD, Orthopedic Department, Faculty of Medicine, Prince of Songkla University, Songkla, Thailand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

May 15, 2013

First Submitted That Met QC Criteria

May 21, 2013

First Posted (ESTIMATE)

May 22, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 22, 2013

Last Update Submitted That Met QC Criteria

May 21, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSU-0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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