Trial Outcomes & Findings for The Effects of Dexamethasone on the Duration of Sciatic Nerve Blocks (NCT NCT00616603)

Last Updated: 2014-06-11

Results Overview

Intraoperative opioid requirement PACU opioid requirement Floor opioid usage Time of onset of motor block (or weakness) Time of onset of sensory block Return of motor function Return of sensation Pain scores

Recruitment status

TERMINATED

Study phase

Target enrollment

43 participants

Primary outcome timeframe

from the time the block was placed up to 24 hours

Results posted on

2014-06-11

Participant Flow

The recruitment process began on 10/4/2007. The last subject to be recruited was on 02/23/2009. Subjects were consented at their Pre-anesthesia appointment or in the Observation Unit prior to their surgery.Some subjects were pre-consented by a resident on the phone prior to their surgery date.

We had 4 subjects withdraw because of screen failure, rescheduled surgery and physcian withdrawal.

Participant milestones

Participant milestones
Measure	Group A This is the control arm and subjects in Group A will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV of normal saline.	Group B Subjects in Group B will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 8mg Dexamethasone + 2ml IV of normal saline.	Group C Subjects in Group C will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV (8mg)of Dexamethasone.
Overall Study COMPLETED	12	14	13
Overall Study NOT COMPLETED	2	0	2
Overall Study STARTED	14	14	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Group A This is the control arm and subjects in Group A will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV of normal saline.	Group B Subjects in Group B will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 8mg Dexamethasone + 2ml IV of normal saline.	Group C Subjects in Group C will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV (8mg)of Dexamethasone.
Overall Study Physician Decision	2	0	2

Baseline Characteristics

The Effects of Dexamethasone on the Duration of Sciatic Nerve Blocks

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A n=14 Participants This is the control arm and subjects in Group A will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV of normal saline.	Group B n=14 Participants Subjects in Group B will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 8mg Dexamethasone + 2ml IV of normal saline.	Group C n=15 Participants Subjects in Group C will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV (8mg)of Dexamethasone.	Total n=43 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	18 Participants n=4 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	25 Participants n=4 Participants
Age, Continuous	63.154 years STANDARD_DEVIATION 10.597 • n=5 Participants	67.692 years STANDARD_DEVIATION 7.357 • n=7 Participants	67.714 years STANDARD_DEVIATION 7.859 • n=5 Participants	65.525 years STANDARD_DEVIATION 9.140 • n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	22 Participants n=4 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	21 Participants n=4 Participants
Region of Enrollment United States	14 participants n=5 Participants	14 participants n=7 Participants	15 participants n=5 Participants	43 participants n=4 Participants

PRIMARY outcome

Timeframe: from the time the block was placed up to 24 hours

Population: PI left the institution and no analysis completed due to questionable data integrity

Outcome measures

Outcome data not reported

Adverse Events

Group B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group C

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

Patricia Moore, CCRP

Loma Linda University Department of Anesthesiology

Phone: 909-558-8493

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place