Preventing the Obturator Nerve Reflex

NCT01547637 | Completed

• 1 other identifier: PRAMS039186EP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The key objective of this study is to compare success rates of ultrasound guided obturator nerve block and anatomic landmark guided obturator nerve block as determined by neuromonitoring endpoints and surgeon observations.

Conditions

Bladder Injury

Keywords

Obturator nerve block; Regional anesthesia; TURBT

Outcome Measures

Primary Outcomes (1)

• Nerve conduction velocity

  Neuromonitoring technician will measure and record obturator nerve conduction velocity in pre-defined time intervals after performance of obturator nerve block.

  1 day

Study Arms (2)

Ultrasound Guided

EXPERIMENTAL

Ultrasound guided obturator nerve block will be performed after induction of general anesthesia. The anterior and posterior divisions of the obturator nerve will be identified with ultrasound. A stimulating needle will be inserted under direct ultrasound visualization. The anterior division will be blocked first. When adductor twitches are present at less than or equal to 0.5 mA, 10 ml of 2% lidocaine will be injected. Next, the needle will be re-directed under direct ultrasound visualization towards the posterior branch of the obturator nerve. After twitches \< 0.5 mA are achieved then 10 mL of 2% lidocaine will be injected when the needle tip is visualized in proximity of the posterior branch.

Procedure: Obturator nerve block

Anatomic landmark

EXPERIMENTAL

Obturator nerve block will be performed after induction of general anesthesia. The adductor magnus tendon approach will be used. A 4 cm insulated stimulating needle will be used to verify location of the obturator nerve by contraction of the thigh adductor group. The needle will be advanced until nerve stimulation is still present at less than or equal to 0.5 mA. When the appropriate nerve stimulation is achieved 10 ml of 2% lidocaine will be injected in divided doses with frequent aspiration. Nerve conduction studies will be repeated once a minute for the first 10 minutes after block completion.

Procedure: Obturator nerve block

Interventions

Obturator nerve block PROCEDURE

Peripheral obturator nerve block using 10 ml of 2% lidocaine

Also known as: anatomic obturator block

Anatomic landmark

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing TURBT for lateral wall bladder tumors at risk for electrical stimulation as determined by the attending surgeon.

You may not qualify if:

• Pre-existing obturator nerve injury
• Thigh adductor muscle weakness
• Neuropathy
• Local anesthetic allergy
• Infection at the site of injection
• Abnormal coagulation studies
• use of neuromuscular blocking medications (if deemed necessary by attending anesthesiologist caring for the patient).

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Study Officials

• Jonathan A Anson, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assitant professor of Anesthesiology

Study Record Dates

• First Submitted: February 29, 2012
• First Posted: March 8, 2012
• Study Start: May 1, 2012
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: May 31, 2018

Record last verified: 2018-05

Locations

US (1)