Comparison of Two Position for Ultrasound Guided Lumbar Plexus and Sciatic Nerve Block - Full Text View

Purpose

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.

Condition	Intervention
Lower Limb Surgery	Procedure: SGPP Procedure: SGTPP Procedure: SGLP Procedure: SGTLP

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Comparison of Lateral Decubitus Position Versus Prone Position for Ultrasound Guided Posterior Lumbar Plexus Block and Sciatic Nerve Block

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Further study details as provided by Huazhong University of Science and Technology:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	April 2009
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

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

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00988234

Locations

China, Hubei
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030

Sponsors and Collaborators

Huazhong University of Science and Technology

Investigators

Study Chair:

Yuke Tian, MD.

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

More Information

No publications provided

Responsible Party:	Yuke Tian/ Professor, Department of Anesthesiology, Tongji Hospital, Tongji medical college, Huazhong University of science and Technology
ClinicalTrials.gov Identifier:	NCT00988234 History of Changes
Other Study ID Numbers:	TJHMZK01001
Study First Received:	October 1, 2009
Last Updated:	February 16, 2011
Health Authority:	China: Health Department of Hubei Province

Keywords provided by Huazhong University of Science and Technology:

Lumbar plexus block
sciatic nerve block
position
ultrasound guidance
elective lower limb surgery

ClinicalTrials.gov processed this record on May 23, 2013