NCT00988234

Brief Summary

In the present study, the investigators will test the effect of two position on posterior lumbar plexus and subgluteal or sub-greater trochanter sciatic nerve block.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2009

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

Study Start

First participant enrolled

April 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 17, 2011

Status Verified

February 1, 2011

Enrollment Period

1.7 years

First QC Date

October 1, 2009

Last Update Submit

February 16, 2011

Conditions

Keywords

Lumbar plexus blocksciatic nerve blockpositionultrasound guidanceelective lower limb surgery

Outcome Measures

Primary Outcomes (2)

  • Block success defined as loss of sensation to pinprick in each of the lumbar plexus and sciatic nerve distributions when measured 30 min after block performance.

    30min

  • Motor blockade was evaluated by assessing the strength of knee extension (femoral nerve), thigh adduction (obturator nerve), and plantar flexion and dorsiflexion of the ankle (sciatic nerve) 30 min after block performance.

    30min

Secondary Outcomes (1)

  • block execution time, depth of the nerve, needle depth, duration of the sensory and motor blockade, complications such as inadvertent needle puncture of epidural space, dural puncture, peritoneal puncture, and kidney or ureter puncture and nerve injury.

    within 48h

Study Arms (4)

SGPP

EXPERIMENTAL

ultrasound guided posterior lumbar plexus block and subgluteal sciatic nerve block under prone position

Procedure: SGPP

SGTPP

EXPERIMENTAL

ultrasound guided posterior lumbar plexus block and sub-greater trochanter approach under prone position

Procedure: SGTPP

SGLP

EXPERIMENTAL

ultrasound guided posterior lumbar plexus block and subgluteal sciatic nerve block under lateral decubitus position

Procedure: SGLP

SGTLP

EXPERIMENTAL

ultrasound guided posterior lumbar plexus block and sub-greater trochanter approach under lateral decubitus position

Procedure: SGTLP

Interventions

SGPPPROCEDURE

ultrasound guided posterior lumbar plexus block and subgluteal sciatic nerve block under prone position

SGPP
SGTPPPROCEDURE

ultrasound guided posterior lumbar plexus block and sub-greater trochanter approach under prone position

SGTPP
SGLPPROCEDURE

ultrasound guided posterior lumbar plexus block and subgluteal sciatic nerve block under lateral decubitus position

SGLP
SGTLPPROCEDURE

ultrasound guided posterior lumbar plexus block and sub-greater trochanter approach under lateral decubitus position

SGTLP

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 75 years old
  • elective unilateral lower limb surgery
  • ASA Physical Status ASA I-III

You may not qualify if:

  • age \<18 or \>75 year old
  • ASA Physical Status \>ASA III
  • abnormal blood coagulation
  • infection near puncture place
  • nerve injury
  • bilateral lower limb surgery
  • patients with lumbar vertebral trauma
  • inability to be properly positioned
  • chronic narcotic therapy or illicit drug use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Study Officials

  • Yuke Tian, MD.

    Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 1, 2009

First Posted

October 2, 2009

Study Start

April 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

February 17, 2011

Record last verified: 2011-02

Locations