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

This study has been completed.
Sponsor:
Information provided by:
Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00988234
First received: October 1, 2009
Last updated: February 16, 2011
Last verified: February 2011
  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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 01, 2014