Comparison of Nerve Stimulating Approach and Interfascial Injection Approach During Sono-guided Obturator Nerve Block

NCT02452944 | Completed Results

• 1 other identifier: GAIRB2014-337
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief Summary

Transurethral resection of bladder tumor (TURB) has been essential treatment for bladder tumours. Direct electrical stimulation of an obturator nerve during the TURB procedures can trigger an inadvertent adductor muscle spasm, which can cause a serious complication like bladder perforation. General anesthesia with muscle relaxants for TURB does not guarantee a prevention of the adductor muscle spasm. Spinal anesthesia with selective obturator nerve block (ONB) can be an alternative anesthesia for TURB, but adductor spasm can also be induced because of incomplete ONB. Recently, ultrasound guidance with nerve stimulator has been used to enhance the safety, efficacy and shortening the onset time of ONB. Some papers describe that comparable ONB can be done using ultrasound only without nerve stimulator, in which there is a principle that obturator nerve runs along a given pathway. Basically, obturator nerve is divided into two branches after exiting the obturator canal. The anterior branch is located in the fascial planes among adductor longus, adductor brevis and pectineus muscles, and the posterior branch is located between the adductor brevis and adductor magnus muscles at the inguinal area. But it has been known that there are many branching patterns of obturator nerve and high anatomic variability in the inguinal area in a cadaver study. And subdivisions of obturator nerve in the inguinal area have been described. Therefore, this study was conducted to investigate the success rate of ultrasound-guided obturator nerve block with interfascial injection approach group (US-IFI; experimental group) was comparable to ultrasound-guided obturator nerve block with nerve stimulating approach group (US-NS; control group) in TURB under spinal anesthesia. And we also evaluated adductor muscle twitching patterns at the inguinal region when the ONB was performed.

Conditions

Bladder Cancer

Keywords

nerve stimulator, obturator nerve, ultrasound

Outcome Measures

Primary Outcomes (1)

• Success Rate of Ultrasound-guided Obturator Nerve Block With US-IFI Group and US-NS Group

  We used only the nerve stimulator for confirming the success or fail of the ONB before the surgery, so we assumed that the US-NS group had complete ONB in all patients. In US-IFI group, complete ONB was confirmed with nerve stimulator at the end of the procedure, and if the residual twitching remained, the case was considered to be a 'fail'.

  up to 8 weeks

Secondary Outcomes (1)

• Count the Number of Sub-divisions of Obturator Nerve at the Inguinal Crease

  up to 8 weeks

Study Arms (2)

US-IFI group

EXPERIMENTAL

ultrasound-guided obturator nerve block with interfascial injection approach group (US-IFI; experimental group) The stimulating needle without nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and adductor brevis muscles. 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and adductor magnus muscles, another 5mL of LA was injected. After that, the needle was reinserted to the same spots attached with nerve stimulator at 1.0 mA. If adductor muscle twitching was shown, another 5mL of LA was injected, and it was documented as 'fail'.

Device: nerve stimulator (stimuplex HNS12); Device: ultrasound

US-NS group

ACTIVE COMPARATOR

ultrasound-guided obturator nerve block with nerve stimulating approach group (US-NS; control group) The stimulating needle attached to a nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and adductor brevis muscles. The nerve stimulator was then turned on, and the stimulation current started at 0.5 mA. If adductor muscle twitching was observed on the sonogram even at the stimulation current 0.3mA, 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and adductor magnus muscles. The stimulation current started at 0.5 mA. If adductor muscle twitching was visualized on the sonogram even at 0.3mA, another 5mL of LA was injected.

Device: nerve stimulator (stimuplex HNS12); Device: ultrasound

Interventions

nerve stimulator (stimuplex HNS12) DEVICE

whether using the nerve stimulator or not when the investigators do the ultrasound-guided obturator nerve block

US-IFI group; US-NS group

ultrasound DEVICE

we did obturator nerve block with ultrasound guided method for searching the fascias where the anterior and posterior branches of obturator nerve run.

US-IFI group; US-NS group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all patients anticipating transurethral resection of bladder tumors with American Society of Anesthesiologists physical status(ASA) I or II

You may not qualify if:

• patients with diabetes or peripheral neuropathy; motor or sensory deficits in the lower extremities, ASA greater than III, coagulation disorders, anticoagulant medication, known allergy to local anesthetics, contraindications for spinal anesthesia (infection at injection site, severe scoliosis or fusion operation), uncooperative patients and patients' refusal

Sponsors & Collaborators

• Gachon University Gil Medical Center: lead

Related Publications (1)

• Anagnostopoulou S, Kostopanagiotou G, Paraskeuopoulos T, Chantzi C, Lolis E, Saranteas T. Anatomic variations of the obturator nerve in the inguinal region: implications in conventional and ultrasound regional anesthesia techniques. Reg Anesth Pain Med. 2009 Jan-Feb;34(1):33-9. doi: 10.1097/AAP.0b013e3181933b51.

  PMID: 19258986 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Limitations and Caveats

We checked the success or fail with nerve stimulator only before beginning the surgery. Therefore, the possibility of incomplete anterior or posterior branch block due to the investigator's miss still remained, which is a limitation of this study.

Results Point of Contact

• Title: Mi Geum Lee
• Organization: Department of Anesthesiology, Gachon University Gil Hospital

mikeum2@gilhospital.com

82-32-460-3637

Study Officials

• Mi Geum Lee, MD, PhD

  Gachon University Gil Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: May 7, 2015
• First Posted: May 25, 2015
• Study Start: December 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: May 1, 2015
• Last Updated: February 8, 2016
• Results First Posted: July 23, 2015

Record last verified: 2016-01