Trial Outcomes & Findings for Dexamethasone and Lower Extremity Block Duration (NCT NCT01756586)

NCT ID: NCT01756586

Last Updated: 2017-06-27

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

4 participants

Primary outcome timeframe

3 days

Results posted on

2017-06-27

Participant Flow

Participant milestones

Participant milestones
Measure
Control
Plain bupivacaine Bupivacaine: Control
Experimental
Bupivacaine with Dexamethasone Dexamethasone Bupivacaine: Control
Overall Study
STARTED
2
2
Overall Study
COMPLETED
0
0
Overall Study
NOT COMPLETED
2
2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dexamethasone and Lower Extremity Block Duration

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Control
n=2 Participants
Plain bupivacaine Bupivacaine: Control
Experimental
n=2 Participants
Bupivacaine with Dexamethasone Dexamethasone Bupivacaine: Control
Total
n=4 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
2 Participants
n=5 Participants
2 Participants
n=7 Participants
4 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Region of Enrollment
United States
2 participants
n=5 Participants
2 participants
n=7 Participants
4 participants
n=5 Participants

PRIMARY outcome

Timeframe: 3 days

Population: Did not have resources to follow up with the subjects after the surgery. The study was terminated early.

Outcome measures

Outcome data not reported

Adverse Events

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Experimental

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

TARIQ MALIK

University of Chicago

Phone: 773-834 3643

Results disclosure agreements

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