NCT02779166

Brief Summary

Celecoxib is commonly used for perioperative pain control for certain orthopaedic procedures. It has been shown to be successful in assisting in pain control for knee arthroscopy. It has not previously been studied in hip arthroscopy. This is a double blinded randomized controlled trial to determine the efficacy of celecoxib in perioperative pain control for hip arthroscopy.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 20, 2016

Completed
3 years until next milestone

Results Posted

Study results publicly available

May 14, 2019

Completed
Last Updated

September 23, 2019

Status Verified

September 1, 2019

Enrollment Period

3.4 years

First QC Date

May 13, 2016

Results QC Date

February 13, 2017

Last Update Submit

September 19, 2019

Conditions

Keywords

hip arthroscopy

Outcome Measures

Primary Outcomes (3)

  • Visual Analog Score for Pain (VAS) in the Immediate Post Operative Period

    The pain VAS is a uni dimensional measure of pain intensity. It is a continuous scale comprised of a 0-10 pain rating. A score of 0 indicates no pain while a score of 10 would indicate extreme pain.

    Pre operative on day of surgery, immediately following OR close, 1 hr post operatively, 2 hrs post operatively

  • Total Narcotic Consumption in the Post Anesthesia Care Unit (PACU)

    Monitored consumption of narcotic medications following surgery, measured in morphine equivalents

    duration of PACU stay,immediate post op period up to a maximum of 4 hours postoperatively

  • Time to Discharge Following Surgery

    Total time to discharge from OR close following surgery, measured in minutes

    time from OR to discharge, up to a maximum of 6 hours postoperatively

Study Arms (2)

Intervention

EXPERIMENTAL

Received 400mg celecoxib prior to surgery

Drug: Celecoxib

Placebo

PLACEBO COMPARATOR

Received placebo pill prior to surgery

Drug: placebo

Interventions

Received 400mg celecoxib prior to surgery

Intervention
Placebo

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients who are undergoing a hip arthroscopy procedure at Northwestern Memorial Hospital with Dr. Michael Terry.

You may not qualify if:

  • Pregnant women and any patient under the age of 18 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Celecoxib

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Michael Terry
Organization
Northwestern Univeristy Department of Orthopaedic Surgery

Study Officials

  • Michael Terry, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 13, 2016

First Posted

May 20, 2016

Study Start

August 1, 2012

Primary Completion

January 1, 2016

Study Completion

May 1, 2016

Last Updated

September 23, 2019

Results First Posted

May 14, 2019

Record last verified: 2019-09