Current Intensity for the Obturator Nerve Block (Current_ONB)

August 28, 2023 updated by: Ki Tae Jung, Chosun University Hospital

The Difference in the Current Intensity for the Obturator Nerve Block According to the Presence or Absence of Neuromuscular Blockage

The purpose of the present study was to find out the difference in current intensity required for nerve stimulation according to the presence or absence of neuromuscular blockade during the obturator nerve block procedure for TURP.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

During the transurethral resection of bladder tumors (TURBT) procedure under spinal anesthesia, the obturator nerve block is required to prevent the accidental movement of adductor longus muscles by electrical stimulation. However, during general anesthesia, the contraction of the adductor longus muscle would be lost due to deep neuromuscular blockade. However, some reports showed that the contraction of the adductor longus muscle occurs even in the deep neuromuscular blockade.

The current intensity for the nerve stimulation during nerve block is 0.3--0.5 mA when the needle tip is near the nerve. However, it is still unknown what current intensity is required to show the contraction of the adductor longus muscle when the patient is in a deep neuromuscular blockade.

Therefore, in this study, investigators aimed to determine the difference in current intensity required for nerve stimulation according to the presence or absence of neuromuscular blockade during obturator nerve block for TURP. In addition, investigators aimed to determine that the obturator nerve block is required during the TURP procedure in patients with deep neuromuscular blockade during general anesthesia.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Gwangju, Korea, Republic of, 61453
        • Recruiting
        • Chosun University Hospital
        • Contact:
        • Sub-Investigator:
          • Su Yeon Cho, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients undergoing TURP procedure

Exclusion Criteria:

  • Patients with anatomical or functional anomaly in the upper airways
  • Patients with neuromuscular disease
  • Patients with hip joint disorders
  • BMI of < 18.5 or > 30.0 kg/m2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Current intensity
  1. An I-gel mask is inserted for the mechanical ventilator of the patient who is sedated with propofol.
  2. For the ultrasound-guided obturator nerve (ON) block, and needle tip gradually advanced to the anterior branch of the ON. The current intensity for the stimulation of ON starts at 1.0 mA (using the sequential electrical nerve stimulation mode), and the needle is advanced gradually to the location where the contraction of the adductor longus muscle (ALM) occurs at 0.3-0.5 mA.
  3. After fixing the needle in that position, measure the current intensity.
  4. Then, rocuronium (0.6 mg/kg) is administered under quantitative neuromuscular-blockade monitoring.
  5. When the train-of-four count becomes 0, the current intensity is increased until the contraction of the ALM occurs.
  6. The current intensity is measured when the contraction of the ALM occurs.
Drug: Rocuronium Bromide
After measuring the initial current intensity, quantitative neuromuscular blockade monitoring is applied, and rocuronium (0.6 mg/kg) is administered.
Other Names:
  • Rocuronium
Diagnostic test: Nerve stimulator
Measuring the minimum current intensity for the stimulation of the obturator nerve to show the contraction of the adductor longus muscle.
Other Names:
  • Stimuplex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Initial current intensity
Time Frame: About 5 minutes after starting obturator nerve block procedure
The current intensity for the stimulation of the obturator nerve starts at 1.0 mA (using the sequential electrical nerve stimulation mode), and the needle is advanced gradually to the location where the stimulus response occurs at 0.3-0.5 mA. After fixing the needle position in a position where contraction of the adductor longus muscle responds to the minimum current intensity, measure the current intensity.
About 5 minutes after starting obturator nerve block procedure
Final current intensity
Time Frame: About 10 minutes after starting obturator nerve block procedure
After administration of rocuronium (0.6 mg/kg), when the train-of-four count becomes 0, the current intensity for the stimulation of the obturator nerve is increased until the contraction of the adductor longus muscle occurs. The current intensity is measured when the contraction of the adductor longus muscle occurs.
About 10 minutes after starting obturator nerve block procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Current intensity after the administration of rocuronium (0.6 mg/kg)
Time Frame: Between 5 minutes and 10 minutes after starting obturator nerve block procedure
After administration of rocuronium (0.6 mg/kg), the quantitative neuromuscular blockade monitoring using train-of-four is observed with 12 seconds interval. At each time point, the current intensity for the obturator nerve is increased until the contraction of the adductor longus muscle occurs. The current intensity at each time point is measured.
Between 5 minutes and 10 minutes after starting obturator nerve block procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chosun University Hospital

Investigators

  • Study Chair: Ki Tae Jung, M.D., Ph.D., Chosun University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

May 12, 2023

First Submitted That Met QC Criteria

May 22, 2023

First Posted (Actual)

May 24, 2023

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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