- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00988234
Comparison of Two Position for Ultrasound Guided Lumbar Plexus and Sciatic Nerve Block
February 16, 2011 updated by: Huazhong University of Science and Technology
Comparison of Lateral Decubitus Position Versus Prone Position for Ultrasound Guided Posterior Lumbar Plexus Block and Sciatic Nerve Block
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The posterior lumbar plexus block approach was described approximately 30 years ago, using surface anatomical landmarks and a loss-of-resistance technique, but over the years it was almost abandoned for its low successful rate, the huge numbers of adverse effects and its difficulties to be performed.
The introduction of the nerve stimulator and ultrasound guided technique in recent years increased the success rate in various peripheral nerve blocks and decreased adverse effects.
Ultrasound guided LPB as well as sciatic nerve block technique in a small patient population resulting in a encouraging result, but published clinical data on optimal patient position for ultrasound-guided LPB are limited.
We designed this prospective randomized study to compare the success rate, time of performance and complications of ultrasound guided posterior lumbar plexus block as well as subgluteal or sub-greater trochanter sciatic nerve block under lateral decubitus position v.s.
prone position.
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430030
- Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 71 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 to 75 years old
- elective unilateral lower limb surgery
- ASA Physical Status ASA I-III
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SGPP
ultrasound guided posterior lumbar plexus block and subgluteal sciatic nerve block under prone position
|
ultrasound guided posterior lumbar plexus block and subgluteal sciatic nerve block under prone position
|
|
Experimental: SGTPP
ultrasound guided posterior lumbar plexus block and sub-greater trochanter approach under prone position
|
ultrasound guided posterior lumbar plexus block and sub-greater trochanter approach under prone position
|
|
Experimental: SGLP
ultrasound guided posterior lumbar plexus block and subgluteal sciatic nerve block under lateral decubitus position
|
ultrasound guided posterior lumbar plexus block and subgluteal sciatic nerve block under lateral decubitus position
|
|
Experimental: SGTLP
ultrasound guided posterior lumbar plexus block and sub-greater trochanter approach under lateral decubitus position
|
ultrasound guided posterior lumbar plexus block and sub-greater trochanter approach under lateral decubitus position
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
Time Frame: 30min
|
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.
Time Frame: 30min
|
30min
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
Time Frame: within 48h
|
within 48h
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
October 1, 2009
First Submitted That Met QC Criteria
October 1, 2009
First Posted (Estimate)
October 2, 2009
Study Record Updates
Last Update Posted (Estimate)
February 17, 2011
Last Update Submitted That Met QC Criteria
February 16, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TJHMZK01001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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