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Completed

NCT Number: NCT01547637

Preventing the Obturator Nerve Reflex

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.

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Key information

Conditions

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

About this study

Transurethral resection of bladder tumor (TURBT) is a urologic surgery used in the treatment of non-muscle invasive bladder cancer. A potential complication of this procedure is bladder rupture or injury secondary to adductor muscle contraction from obturator nerve stimulation. This risk is increased in resection of lateral wall tumors, as electrosurgical resection of these lesions is more likely to inadvertently stimulate the obturator nerve.

There are several mechanisms for preventing the obturator reflex. Pharmacologic paralysis can reliably inhibit thigh adduction. However, TURBT is often a short procedure that is not amendable to intermediate duration neuromuscular blocking medications. The use of succinylcholine is another option but is limited by its short duration of action which may not be adequate for the time needed to resect the tumor. Additionally, many patients have contraindications to the use of succinylcholine. Spinal anesthesia does not reliably prevent the obturator reflex.

Regional anesthesia is another potential treatment modality to prevent the obturator reflex during TURBT. Motor blockade of the obturator nerve will prevent this adduction in the event of inadvertent nerve stimulation. Peripheral blockade of the obturator nerve can be combined with either general or spinal anesthesia. Historically, obturator nerve block (ONB) has been considered a technically challenging procedure. Recently, however, successful ultrasound guided ONB techniques have been reported. To the best of our knowledge there has been no study to date comparing the effectiveness of ONB achieved by anatomic landmarks (with nerve stimulation) versus ultrasound guided ONB (with nerve stimulation) at preventing the obturator reflex during TURBT surgery.

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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).

Treatment and study plan

Obturator nerve block

Procedure

Peripheral obturator nerve block using 10 ml of 2% lidocaine

Other names: anatomic obturator block

Primary outcomes

  1. Nerve conduction velocity

    Time frame: 1 day

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

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

Preventing the Obturator Nerve Reflex: A Comparison of Ultrasound Guided Obturator Nerve Block and Classic Anatomic Block Technique.

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Mar 8, 2012
Registry last updated
May 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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