Trial Outcomes & Findings for Does Ultrasound Improve Procedural Time in the Lateral Popliteal Approach to the Sciatic Nerve in Obese Patients (NCT NCT01579747)

Results Overview

Time taken to complete a sciatic nerve block via the lateral popliteal approach using ultrasound vs nerve stimulation technique

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

25 participants

Primary outcome timeframe

less than 30 minutes

Results posted on

2014-01-24

Participant Flow

Patients recruited in UNMH and outpatient's surgical center

1 excluded because not meeting inclusion criteria. Patient lost weight prior to surgery

Participant milestones

Participant milestones
Measure	Nerve Stimulation Sciatic Nerve Block Sciatic nerve block performed with nerve stimulation	Ultrasound Guided Sciatic Nerve Block Sciatic nerve block performed with ultrasound guidance
Overall Study STARTED	12	12
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Does Ultrasound Improve Procedural Time in the Lateral Popliteal Approach to the Sciatic Nerve in Obese Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nerve Stimulation Sciatic Nerve Block n=12 Participants Sciatic nerve block performed with nerve stimulation	Ultrasound Guided Sciatic Nerve Block n=12 Participants Sciatic nerve block performed with ultrasound guidance	Total n=24 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	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	49.3 years STANDARD_DEVIATION 14.3 • n=5 Participants	58.0 years STANDARD_DEVIATION 9.4 • n=7 Participants	53.65 years STANDARD_DEVIATION 11.85 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: less than 30 minutes

Time taken to complete a sciatic nerve block via the lateral popliteal approach using ultrasound vs nerve stimulation technique

Outcome measures

Outcome measures
Measure	Nerve Stimulation Sciatic Nerve Block n=12 Participants Sciatic nerve block performed with nerve stimulation	Ultrasound Guided Sciatic Nerve Block n=12 Participants Sciatic nerve block performed with ultrasound guidance
Procedural Time	577 seconds Standard Deviation 57	206 seconds Standard Deviation 40

SECONDARY outcome

Timeframe: 6 months

Number of needle redirections defined as needle withdrawal followed by advancement as an intentional movement.

Outcome measures

Outcome measures
Measure	Nerve Stimulation Sciatic Nerve Block n=12 Participants Sciatic nerve block performed with nerve stimulation	Ultrasound Guided Sciatic Nerve Block n=12 Participants Sciatic nerve block performed with ultrasound guidance
Number of Redirections	20 passes Interval 20.0 to 20.0	3.5 passes Interval 3.0 to 4.0

Adverse Events

Nerve Stimulation Sciatic Nerve Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ultrasound Guided Sciatic 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

Nicholas Lam

Univeristy of New Mexico

Phone: 505 272 2610

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place