Trial Outcomes & Findings for Regional Anesthesia for Sickle Cell Crisis Using Ultrasound in The Emergency Department: Phase I (NCT NCT01256281)

NCT ID: NCT01256281

Last Updated: 2015-04-23

Results Overview

Pain score in legs at 2-4 hours after intervention will be the primary outcome. Data analysis not done.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

2 participants

Primary outcome timeframe

2-4 hours after intervention

Results posted on

2015-04-23

Participant Flow

Participant milestones

Participant milestones
Measure
Femoral Nerve Block
Patients enrolled will receive ultrasound guided FNB in addition to standard care. If subjects are experiencing pain in both lower extremities, both extremities will be blocked; if subjects are experiencing pain in one lower extremity, only the affected extremity will be blocked.
Overall Study
STARTED
2
Overall Study
COMPLETED
2
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Regional Anesthesia for Sickle Cell Crisis Using Ultrasound in The Emergency Department: Phase I

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Femoral Nerve Block
n=2 Participants
Patients enrolled will receive ultrasound guided FNB in addition to standard care. If subjects are experiencing pain in both lower extremities, both extremities will be blocked; if subjects are experiencing pain in one lower extremity, only the affected extremity will be blocked.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
2 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 2-4 hours after intervention

Pain score in legs at 2-4 hours after intervention will be the primary outcome. Data analysis not done.

Outcome measures

Outcome data not reported

Adverse Events

Femoral Nerve Block

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. Jeffrey Glassberg

Icahn School of Medicine at Mount Sinai

Phone: (212) 824-8056

Results disclosure agreements

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