Trial Outcomes & Findings for Preoperative Etanercept Before Inguinal Hernia Surgery (NCT NCT00825344)

Results Overview

0-10 pain score through 24-hours post-surgery. 0 is no pain and 10 is the worse pain imaginable. The primary outcome reported measure is the average of 4 scores, each comprised of 6-hour time intervals during the 24hour period.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

77 participants

Primary outcome timeframe

24 hours

Results posted on

2017-10-05

Participant Flow

Participant milestones

Participant milestones
Measure	Etanercept Etanercept 50 mg preoperatively Etanercept : 50 mg subcutaenous preoperatively	Saline Subcutaneous saline preoperatively Saline : Given subcutaneously preoperatively
Overall Study STARTED	34	43
Overall Study COMPLETED	33	42
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Preoperative Etanercept Before Inguinal Hernia Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=34 Participants Etanercept 50 mg preoperatively Etanercept : 50 mg subcutaenous preoperatively	Group 2 n=43 Participants Subcutaneous saline preoperatively Saline : Given subcutaneously preoperatively	Total n=77 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	18 Participants n=7 Participants	26 Participants n=5 Participants
Age, Continuous	55.4 years STANDARD_DEVIATION 3.1 • n=5 Participants	58.4 years STANDARD_DEVIATION 2.8 • n=7 Participants	57.9 years STANDARD_DEVIATION 2.9 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	40 Participants n=7 Participants	71 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants	43 participants n=7 Participants	77 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

0-10 pain score through 24-hours post-surgery. 0 is no pain and 10 is the worse pain imaginable. The primary outcome reported measure is the average of 4 scores, each comprised of 6-hour time intervals during the 24hour period.

Outcome measures

Outcome measures
Measure	Etanercept n=34 Participants Etanercept 50 mg preoperatively Etanercept : 50 mg subcutaenous preoperatively	Saline n=43 Participants Subcutaneous saline preoperatively Saline : Given subcutaneously preoperatively
Numerical Rating Scale Pain Score	3.3 units on a scale Standard Deviation 1.9	3.9 units on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: 24 hours

Number of oxycodone/ acetaminophen tablets consumed through 24 hours post-surgery

Outcome measures

Outcome measures
Measure	Etanercept n=34 Participants Etanercept 50 mg preoperatively Etanercept : 50 mg subcutaenous preoperatively	Saline n=43 Participants Subcutaneous saline preoperatively Saline : Given subcutaneously preoperatively
Analgesic Usage	4.0 tablets Standard Deviation 2.8	5.8 tablets Standard Deviation 4.2

SECONDARY outcome

Timeframe: Up to 12 months

Patients with persistent post-surgical pain

Outcome measures

Outcome measures
Measure	Etanercept n=33 Participants Etanercept 50 mg preoperatively Etanercept : 50 mg subcutaenous preoperatively	Saline n=42 Participants Subcutaneous saline preoperatively Saline : Given subcutaneously preoperatively
Chronic Post-surgical Pain	5 participants	5 participants

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2

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. Steven P. Cohen

Johns Hopkins

Phone: 410-955-1818

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place