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Preemptive Analgesia in Cruciate Reconstruction

Primary Purpose

Anterior Cruciate Ligament Injury

Status

Completed

Phase

Phase 3

Locations

Thailand

Study Type

Interventional

Intervention

Celecoxib

etoricoxib

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injury focused on measuring preemptive analgesia, cruciate ligament

Eligibility Criteria

15 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

patients with anterior cruciate ligament injury age 15-50 yr

Exclusion Criteria:

previous knee surgery

Sites / Locations

Prince of Songkla University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

placebo

Arm Description

identical placebo

Outcomes

Primary Outcome Measures

VAS score

Secondary Outcome Measures

number of analgesic used

Full Information

NCT ID

NCT01017380

First Posted

November 17, 2009

Last Updated

November 19, 2009

Sponsor

Prince of Songkla University

1. Study Identification

Unique Protocol Identification Number

NCT01017380

Brief Title

Preemptive Analgesia in Cruciate Reconstruction

Official Title

Comparing Etoricoxib and Celecoxib for Preemptive Analgesia for Acute Postoperative Pain in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Prince of Songkla University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The aims of this study was to compare analgesic efficacy of preoperative administration of etoricoxib versus celecoxib for post-operative pain relief after arthroscopic anterior cruciate ligament reconstruction. One hundred and two patients diagnosed as anterior cruciate ligament injury will randomized into 3 groups using opaque envelope. Both patients and surgeon were blinded to the allocation. All of the patients will be operated by one orthopaedic surgeon under regional anesthesia. Each group will be given either etoricoxib 120 mg., celecoxib 400 mg., or placebo 1 hour prior to operative incision. Post-operative pain intensity, time to first dose of analgesic requirement and numbers of analgesic used for rescue pain control and adverse events will be recorded periodically to 48 hours after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anterior Cruciate Ligament Injury

Keywords

preemptive analgesia, cruciate ligament

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

placebo

Arm Type

Experimental

Arm Description

identical placebo

Intervention Type

Drug

Intervention Name(s)

Celecoxib

Intervention Description

celecoxib 400 mg 1 cap before surgery

Intervention Type

Drug

Intervention Name(s)

etoricoxib

Intervention Description

120 mg 1 tab before surgery

Primary Outcome Measure Information:

Title

VAS score

Time Frame

6,12,24,48 hour postoperative

Secondary Outcome Measure Information:

Title

number of analgesic used

Time Frame

48 hour postoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients with anterior cruciate ligament injury age 15-50 yr Exclusion Criteria: previous knee surgery

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boonsin Tangtrakulwanich, MD.,Ph.D

Organizational Affiliation

Faculty of Medicine, Prince of Songkla University

Official's Role

Study Director

Facility Information:

Facility Name

Prince of Songkla University

City

Hat Yai

State/Province

Songkhla

ZIP/Postal Code

90110

Country

Thailand

12. IPD Sharing Statement

Citations:

PubMed Identifier

20973952

Citation

Boonriong T, Tangtrakulwanich B, Glabglay P, Nimmaanrat S. Comparing etoricoxib and celecoxib for preemptive analgesia for acute postoperative pain in patients undergoing arthroscopic anterior cruciate ligament reconstruction: a randomized controlled trial. BMC Musculoskelet Disord. 2010 Oct 25;11:246. doi: 10.1186/1471-2474-11-246.

Results Reference

derived

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Preemptive Analgesia in Cruciate Reconstruction

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