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Clinical Trials/NCT02020096
NCT02020096
Completed
Not Applicable

A Randomized Comparison of Ultrasound Plus Nerve Stimulator Guided Lumbar Plexus Block to Conventional Nerve Stimulator Guided Technique Using Winnie Approach

Huazhong University of Science and Technology1 site in 1 country48 target enrollmentJanuary 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Arthroscopy Surgery
Sponsor
Huazhong University of Science and Technology
Enrollment
48
Locations
1
Primary Endpoint
Onset time of sensory block to cold and pinprick
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Ultrasound imaging, an effective tool to localize peripheral nerves, may facilitate block performance. It allows direct visualization of nerve structures, needle guidance in real-time to the target, and observation of local anesthetic diffusion. Some case series have demonstrated significantly faster onset time for interscalene blocks, supraclavicular blocks and axillary brachial plexus blocks under ultrasound than with conventional techniques. Ultrasound guidance also enhances the quality of popliteal sciatic nerve block at the popliteal fossa compared with single injection, nerve stimulator-guided block using either a tibial or peroneal endpoint. Despite this impressive profile, the application of the ultrasound for lumbar plexus blocks has not been studied extensively. It is likely that lumbar plexus block (LPB) combined with either a sciatic nerve block or sedation or both is equivalent to general anesthesia and neuraxial anesthesia for knee arthroscopy. The lumbar plexus block is traditionally performed using surface anatomical landmarks and nerve stimulation. Ultrasound imaging of the anatomy relevant for LPB is challenging because of its deep anatomic location and the "acoustic shadow" of the overlying transverse processes. Recently, Karmakar M.K. etc. has demonstrated that a paramedian transverse scan (PMTS) of the lumbar paravertebral region with the ultrasound beam being insonated through the intertransverse space (ITS) and directed medially toward the intervertebral foramen (PMTS-ITS) may overcome the problem of the "acoustic shadow" and allow clear visualization of the anatomy relevant for LPB. However, the application of a PMTS-ITS used for lumbar plexus blocks has not been studied extensively and its advantages are not validated in a clinical study. Thus, we designed this prospective, randomized, subject and assessor blinded, parallel-group, active-controlled study to compare a PMTS ultrasound-guided lumbar plexus block combined with nerve stimulation and a conventional technique on time required to readiness for surgery in patients undergo knee arthroscopy surgery.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
October 2014
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wei Mei

Associate Professor

Huazhong University of Science and Technology

Eligibility Criteria

Inclusion Criteria

  • Informed consent
  • Age 18-70yr
  • American Society of Anesthesiologists physical status I-II
  • Patients scheduled to undergo knee arthroscopy surgery
  • Ultrasound visibility score equal or great than 10

Exclusion Criteria

  • Body mass index more than 35 kg/m²
  • Pregnant or lactating women
  • Allergy to local anesthetics
  • Coagulopathy, on anticoagulants
  • Malignancy or infection at puncture site
  • Significant peripheral neuropathy or diabetic peripheral neuropathy
  • Language barrier
  • Neuropsychiatric disorder
  • Severe cardiac or respiratory diseases
  • Pathology or previous surgery or trauma to the lower limb

Outcomes

Primary Outcomes

Onset time of sensory block to cold and pinprick

Time Frame: up to 40 min after ropivacaine injection

Onset time of sensory block (cold/pinprick), defined as time interval from completion of local anesthetic injection to the achievement of complete sensory block (defined as no sensation in three major branches including the femoral nerve, the lateral femoral cutaneous nerve and the obturator nerve) .

Secondary Outcomes

  • Incidence of paresthesia during block(up to 20min after needle insertion)
  • Performance time of block(up to 20 min after needle insertion)
  • Number of needle passes during block(up to 20min after needle insertion)
  • Total ultrasound visibility score (UVS)(30 min before and 5 min after lumbar plexus block)
  • Onset time of motor block(up to 40min after ropivacaine injection)
  • Incidence of accidental vascular puncture(up to 20min after needle insertion)
  • Changes of muscle strength of quadriceps femoris and adductors(up to 40min after ropivacaine injection)
  • Minimal stimulating current of the needle(up to 20min after needle insertion)

Study Sites (1)

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