NCT03678961

Brief Summary

Little is known about which posture of lower extremity makes it easier to access to the sciatic nerve. In this study, the investigators aimed to identify the most appropriate positioning of the lower extremity during anterior-approach ultrasound-guided sciatic nerve block.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

August 30, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 20, 2018

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2018

Completed
Last Updated

December 20, 2018

Status Verified

December 1, 2018

Enrollment Period

1 month

First QC Date

August 17, 2018

Last Update Submit

December 19, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Visibility of sciatic nerve

    Visibility of sciatic nerve at each position assessed using a scoring system (0, no nerve identified; 1, nerve identified with a high probability; 2, nerve identified, but most of it not visible; 3, nerve identified, more than 50% of its borders can be precisely distinguished from surrounding structures; 4, nerve completely visible, but fascicles poorly defined; 5, nerve completely visible and multiple fascicles identifiable.)

    during 10 minutes of anesthesia induction

Secondary Outcomes (1)

  • Depth of sciatic nerve

    during 10 minutes of anesthesia induction

Study Arms (4)

Group N

Neutral position

Group E

External rotation of leg by 45 degrees

Behavioral: external rotation of leg

Group EF45

External rotation of leg by 45 degrees, hip flexion by 45 degrees, and knee flexion by 45 degrees

Behavioral: external rotation of legBehavioral: hip flexion and knee flexion

Group EF15

External rotation of leg by 45 degrees, hip flexion by 15 degrees, and knee flexion by 15 degrees

Behavioral: external rotation of legBehavioral: hip flexion and knee flexion

Interventions

external rotation of leg by 45 degrees

Group EGroup EF15Group EF45

hip flexion by 15/45 degrees and knee flexion by 15/45 degrees

Group EF15Group EF45

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing knee surgery requiring peripheral nerve block

You may qualify if:

  • ASA PS 1-3
  • patients undergoing knee surgery requiring peripheral nerve block

You may not qualify if:

  • patients who refuse to participate in the study
  • BMI \> 40 kg/m2
  • patients who have congenital abnormality on leg
  • patients who have surgery or trauma on hip/knee
  • patients who cannot move freely due to the contracture
  • patients who are judged ineligible by the medical staff to participate in the study for other reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

Study Officials

  • Won Uk Koh, M.D., Ph.D.

    University of Ulsan, College of Medicine, Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Instructor

Study Record Dates

First Submitted

August 17, 2018

First Posted

September 20, 2018

Study Start

August 30, 2018

Primary Completion

October 11, 2018

Study Completion

October 11, 2018

Last Updated

December 20, 2018

Record last verified: 2018-12

Locations