Ultrasound Plus Nerve Stimulator Versus Nerve Stimulator Guided Lumbar Plexus Block

NCT02020096 | Completed DMC

• 1 other identifier: TJMZK20131001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Arthroscopy Surgery

Keywords

Lumbar plexus block; Ultrasound guidance; Nerve stimulator

Outcome Measures

Primary Outcomes (1)

• Onset time of sensory block to cold and pinprick

  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) .

  up to 40 min after ropivacaine injection

Secondary Outcomes (8)

• Total ultrasound visibility score (UVS)

  30 min before and 5 min after lumbar plexus block

• Performance time of block

  up to 20 min after needle insertion

• Number of needle passes during block

  up to 20min after needle insertion

• Minimal stimulating current of the needle

  up to 20min after needle insertion

• Onset time of motor block

  up to 40min after ropivacaine injection

Study Arms (2)

U+N group

EXPERIMENTAL

Ultrasound and nerve stimulator guided lumbar plexus block combined with nerve stimulator guided sciatic block

Procedure: Ultrasound and nerve stimulator guided lumbar plexus block

N group

ACTIVE COMPARATOR

Nerve stimulator guided lumbar plexus block combined with nerve stimulator guided sciatic nerve block

Procedure: Nerve stimulator guided lumbar plexus block

Interventions

Ultrasound and nerve stimulator guided lumbar plexus block PROCEDURE

An insulated nerve block needle connected to a nerve stimulator that was delivering a current of 1.5 mA at a frequency of 2 Hz was then inserted in the long axis (in- plane) of the ultrasound transducer towards the the hypoechoic psoas compartment. If the quadriceps contraction which produces patella twitching was elicited with an initial current of 1.5mA,then the current should be reduced until contraction is still present between 0.3 to 0.5 mA .Afterward, the lumbar plexus nerve block was performed by using 30mL of 0.5% ropivacaine. Contraction should stop below a current of 0.3mA, otherwise intraneural needle position should be suspected.

U+N group

Nerve stimulator guided lumbar plexus block PROCEDURE

The block was conducted following traditional Winnie approach. The accepted end point for the lumbar plexus is stimulation of the femoral nerve component, observed by contraction of the quadriceps muscle. Quadriceps contraction which produces patella twitching should be sought with an initial current of 1.5mA, and once elicited the current should be reduced until contraction is still present between 0.3 to 0.5 mA. Afterward, the lumbar plexus nerve block was performed by using 30mL of 0.5% ropivacaine. Contraction should stop below a current of 0.3mA, otherwise intraneural needle position should be suspected.

N group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Wei Mei, MD., PhD.

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

  PRINCIPAL INVESTIGATOR

• Yuke Tian, MD., PhD.

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 28, 2013
• First Posted: December 24, 2013
• Study Start: January 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 14, 2019

Record last verified: 2019-11

Locations

CN (1)