Trial Outcomes & Findings for IV Steroids Versus Steroids Included in Block for Orthopedic Lower Limb Surgery (NCT NCT03855059)

Results Overview

The investigator would like to investigate if the dexamethasone given IV or with the nerve block in young patients undergoing lower limb surgery produces the same duration of analgesia.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

50 participants

Primary outcome timeframe

24 - 48 hours

Results posted on

2021-07-21

Participant Flow

Participant milestones

Participant milestones
Measure	Intervenous Steroid Steroid given intervenously at the time of Peripheral nerve block	Perineural Steroid Steroid given in syringe with the local anesthetic
Overall Study STARTED	25	25
Overall Study COMPLETED	23	25
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervenous Steroid n=25 Participants Steroid given intervenously at the time of Peripheral nerve block	Perineural Steroid n=25 Participants Steroid given in syringe with the local anesthetic	Total n=50 Participants Total of all reporting groups
Age, Customized Population age	13.24 years n=25 Participants	11.28 years n=25 Participants	12.26 years n=50 Participants
Sex: Female, Male Female	13 Participants n=25 Participants	10 Participants n=25 Participants	23 Participants n=50 Participants
Sex: Female, Male Male	12 Participants n=25 Participants	15 Participants n=25 Participants	27 Participants n=50 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 24 - 48 hours

The investigator would like to investigate if the dexamethasone given IV or with the nerve block in young patients undergoing lower limb surgery produces the same duration of analgesia.

Outcome measures

Outcome measures
Measure	Intervenous Steroid n=23 Participants Steroid given intervenously at the time of Peripheral nerve block	Perineural Steroid n=25 Participants Steroid given in syringe with the local anesthetic
Analgesia Duration	22.1 Hours Standard Deviation 8.9	25.7 Hours Standard Deviation 9.8

Adverse Events

Intervenous Steroid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Perineural Steroid

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

Peter Lichtenthal, MD

University of Arizona/Deptartment of Anesthesiology

Phone: 5206267221

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place