Comparison of Two Position for Ultrasound Guided Lumbar Plexus and Sciatic Nerve Block

Lower Limb Surgery Clinical Trial

Official title:

Comparison of Lateral Decubitus Position Versus Prone Position for Ultrasound Guided Posterior Lumbar Plexus Block and Sciatic Nerve Block

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00988234
• Other study ID #: TJHMZK01001
• Status: Completed
• Phase: N/A
• First received: October 1, 2009
• Last updated: February 16, 2011
• Start date: April 2009
• Est. completion date: December 2010

Study information

• Verified date: February 2011
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health Department of Hubei Province
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lower Limb Surgery

Intervention

Procedure:
• SGPP
ultrasound guided posterior lumbar plexus block and subgluteal sciatic nerve block under prone position
• SGTPP
ultrasound guided posterior lumbar plexus block and sub-greater trochanter approach under prone position
• SGLP
ultrasound guided posterior lumbar plexus block and subgluteal sciatic nerve block under lateral decubitus position
• SGTLP
ultrasound guided posterior lumbar plexus block and sub-greater trochanter approach under lateral decubitus position

Locations

Country	Name	City	State
China	Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	Yes