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Ultrasound Plus Nerve Stimulator Versus Nerve Stimulator Guided Lumbar Plexus Block

Not Applicable
Completed
Conditions
Knee Arthroscopy Surgery
Interventions
Procedure: Ultrasound and nerve stimulator guided lumbar plexus block
Procedure: Nerve stimulator guided lumbar plexus block
Registration Number
NCT02020096
Lead Sponsor
Huazhong University of Science and Technology
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
48
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
  • Analgesics intake, history of substance abuse
  • History of spinal surgery or deformity
  • Ultrasound visibility score less than 10
  • Participating in the investigation of another experimental agent

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
U+N groupUltrasound and nerve stimulator guided lumbar plexus blockUltrasound and nerve stimulator guided lumbar plexus block combined with nerve stimulator guided sciatic block
N groupNerve stimulator guided lumbar plexus blockNerve stimulator guided lumbar plexus block combined with nerve stimulator guided sciatic nerve block
Primary Outcome Measures
NameTimeMethod
Onset time of sensory block to cold and pinprickup 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 Outcome Measures
NameTimeMethod
Incidence of paresthesia during blockup to 20min after needle insertion

Incidence of paresthesia during block reported by patients

Performance time of blockup to 20 min after needle insertion

Performance time of block is the preparing time and procedure time. Preparing time (defined as the time from the beginning of the sterile preparation right before the first needle contact with the skin). Procedure time (time between the insertion of the needle and the end of local anesthetic injection)

Number of needle passes during blockup to 20min after needle insertion

Number of needle passes during block

Total ultrasound visibility score (UVS)30 min before and 5 min after lumbar plexus block

The independent observer attempted to visualize 10 paravertebral structures in images of the ultrasound scans from the patients

Onset time of motor blockup to 40min after ropivacaine injection

onset time of motor block, defined as time interval from completion of local anesthetic injection to the achievement of satisfied motor block (defined as a Modified Bromage scale equal to 3).

Incidence of accidental vascular punctureup to 20min after needle insertion

Incidence of accidental vascular puncture, defined as blood by aspiration.

Changes of muscle strength of quadriceps femoris and adductorsup to 40min after ropivacaine injection

Muscle strength of quadriceps femoris and adductors was measured with hand-held dynamometer (HHD, Hogan Health Industries, MicroFET3) during knee extension and hip adduction.

Minimal stimulating current of the needleup to 20min after needle insertion

All peripheral nerve blocks were performed by the same anesthesiologist with an 100-mm insulated stimulating needle attached to a nerve stimulator. The intensity of the stimulating current, initially set to deliver 1 to 1.5 mA (0.1ms, 2Hz), was gradually decreased to \<0.5 mA while the appropriate motor response was maintained.

For sciatic block, the targeted evoked motor response was plantar flexion of the foot. For lumbar plexus block, quadriceps muscle motor response was targeted.Contraction should stop below a current of 0.2mA, otherwise intraneural needle position should be suspected and the needle should be withdraw and readjusted. The Minimal stimulating current ( intensity of the current when the needle was considered to be adequately positioned) finally demonstrated on nerve stimulator was recorded, then ropivacaine was injected slowly after careful intermittent aspirations.

Trial Locations

Locations (1)

Tongji Hospital

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Wuhan, Hubei, China

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