Trial Outcomes & Findings for Evaluation of Perioperative Celecoxib for Hip Arthroscopy (NCT NCT02779166)

NCT ID: NCT02779166

Last Updated: 2019-09-23

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 98 participants
• Primary outcome timeframe: Pre operative on day of surgery, immediately following OR close, 1 hr post operatively, 2 hrs post operatively
• Results posted on: 2019-09-23

Participant Flow

Participant milestones

Measure	Intervention 50 patients received 400mg celecoxib prior to surgery Celecoxib: Received 400mg celecoxib prior to surgery	Placebo 48 received placebo pill prior to surgery placebo
Overall Study STARTED	50	48
Overall Study COMPLETED	50	48
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Perioperative Celecoxib for Hip Arthroscopy

Baseline characteristics by cohort

Measure	Intervention n=50 Participants Received 400mg celecoxib prior to surgery Celecoxib: Received 400mg celecoxib prior to surgery	Placebo n=48 Participants Received placebo pill prior to surgery placebo	Total n=98 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=5 Participants	48 Participants n=7 Participants	98 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	34.2 years STANDARD_DEVIATION 11.9 • n=5 Participants	35.8 years STANDARD_DEVIATION 11.6 • n=7 Participants	35.0 years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	29 Participants n=7 Participants	55 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	19 Participants n=7 Participants	43 Participants n=5 Participants
Region of Enrollment United States	50 Participants n=5 Participants	48 Participants n=7 Participants	98 Participants n=5 Participants

PRIMARY outcome

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

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.

Outcome measures

Measure	Intervention n=50 Participants 50 patients received 400mg celecoxib prior to surgery Celecoxib: Received 400mg celecoxib prior to surgery	Placebo n=48 Participants 48 received placebo pill prior to surgery placebo
Visual Analog Score for Pain (VAS) in the Immediate Post Operative Period Pre-Operative VAS Score	2.11 score on a scale Standard Error 2.06	2.33 score on a scale Standard Error 1.98
Visual Analog Score for Pain (VAS) in the Immediate Post Operative Period Immediate Post Op VAS Score	4.41 score on a scale Standard Error 3.00	5.02 score on a scale Standard Error 3.10
Visual Analog Score for Pain (VAS) in the Immediate Post Operative Period 1 hr Post Op VAS Score	4.63 score on a scale Standard Error 1.91	5.36 score on a scale Standard Error 1.92
Visual Analog Score for Pain (VAS) in the Immediate Post Operative Period 2 hr Post Op VAS Score	4.11 score on a scale Standard Error 1.75	4.92 score on a scale Standard Error 1.98

PRIMARY outcome

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

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

Outcome measures

Measure	Intervention n=50 Participants 50 patients received 400mg celecoxib prior to surgery Celecoxib: Received 400mg celecoxib prior to surgery	Placebo n=48 Participants 48 received placebo pill prior to surgery placebo
Total Narcotic Consumption in the Post Anesthesia Care Unit (PACU)	15.326 morphine milligram equivalents Standard Deviation 11.0	15.419 morphine milligram equivalents Standard Deviation 13.2

PRIMARY outcome

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

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

Outcome measures

Measure	Intervention n=50 Participants 50 patients received 400mg celecoxib prior to surgery Celecoxib: Received 400mg celecoxib prior to surgery	Placebo n=48 Participants 48 received placebo pill prior to surgery placebo
Time to Discharge Following Surgery	152.9 minutes Standard Deviation 55.2	172.9 minutes Standard Deviation 57.6

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael Terry

Northwestern Univeristy Department of Orthopaedic Surgery

Phone: 312-926-4444

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place