MedDataX Logo

Preemptive Analgesia in Cruciate Reconstruction

NCT ID: NCT01017380

Last Updated: 2009-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anterior Cruciate Ligament Injury

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

preemptive analgesia cruciate ligament

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

placebo

identical placebo

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

celecoxib 400 mg 1 cap before surgery

etoricoxib

Intervention Type DRUG

120 mg 1 tab before surgery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Celecoxib

celecoxib 400 mg 1 cap before surgery

Intervention Type DRUG

etoricoxib

120 mg 1 tab before surgery

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients with anterior cruciate ligament injury age 15-50 yr

Exclusion Criteria

* previous knee surgery
Minimum Eligible Age

15 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Prince of Songkla University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Facuty of Medicine, Prince of Songkla University

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Boonsin Tangtrakulwanich, MD.,Ph.D

Role: STUDY_DIRECTOR

Faculty of Medicine, Prince of Songkla University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Prince of Songkla University

Hat Yai, Changwat Songkhla, Thailand

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Thailand

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 20973952 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EC50/369-007

Identifier Type: -

Identifier Source: org_study_id