Preemptive Analgesia in Cruciate Reconstruction | NCT01017380

Studies
Preemptive Analgesia in Cruciate Reconstruction

NCT01017380

Sponsor

Prince of Songkla University

Status

Completed

Last Update Posted

Nov 20, 2009Estimated

Enrollment

30Actual

Phase

Phase 3

Conditions

Anterior Cruciate Ligament Injury

Interventions

Celecoxib
etoricoxib

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Jan 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Nov 17, 2009

First Submission Date that Met QC Criteria

Nov 19, 2009

First Posted Date

Nov 20, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2009

Last Update Posted Date

Nov 20, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
placebo	Experimental	identical placebo	Drug: Celecoxib Drug: etoricoxib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Celecoxib	Drug	celecoxib 400 mg 1 cap before surgery	placebo
etoricoxib

Measure	Description	Time Frame
VAS score		6,12,24,48 hour postoperative

Measure	Description	Time Frame
number of analgesic used		48 hour postoperative

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with anterior cruciate ligament injury age 15-50 yr

Exclusion Criteria:

previous knee surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Boonsin Tangtrakulwanich, MD.,Ph.D	Faculty of Medicine, Prince of Songkla University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prince of Songkla University		Hat Yai	Changwat Songkhla	90110	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20973952	Derived	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.

ID	Term
D007718	Knee Injuries
D007869	Leg Injuries
D014947	Wounds and Injuries

ID	Term
D000068579	Celecoxib
D000077613	Etoricoxib

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals