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

Comparison of Nerve Stimulating Approach and Interfascial Injection Approach During Sono-guided Obturator Nerve Block in Transurethral Resection of Bladder Tumors Under Spinal Anesthesia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02452944
Enrollment
62
Registered
2015-05-25
Start date
2014-12-31
Completion date
2015-05-31
Last updated
2016-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Keywords

nerve stimulator, obturator nerve, ultrasound

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.

Detailed description

After obtaining approval from the Gachon Gil Hospital Ethical Committee, written informed consent was obtained from all patients anticipating TURB with American Society of Anesthesiologists physical status (ASA) I or II. Sixty two patients anticipating transurethral resection of the bladder tumors (TURB) under spinal anesthesia were enrolled in this randomized controlled trial from December 2014 to May 2015. Exclusion criteria included 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. Routine monitoring was begun and Spinal anesthesia with hyperbaric 0.5% bupivacaine 12-15 mg was performed to reach the level of anesthesia, at least T10 to T4 in all patients. Patients were then randomized into 1 of 2 groups (US-NS vs US-IFI) to receive ONB in the inguinal crease level. Randomization was performed by a computer-generated random numbers table. We counted one side obturator nerve as one, the number. Whether the right or left ONB was done, was decided by surgeon according to the tumor location. If obturator block was done in both sides, let it belong to the same group, and we counted it as two, the number. Patients were then positioned supine, and the affected leg was slightly abducted and rotated externally without knee flexion, and the inguinal region was prepared with a povidone iodine solution. The 10 MHz linear probe (Zonare Medical Systems, California, USA) equipped with a sterile plastic cover and gel. The transducer was positioned parallel to the inguinal crease with 90° to the skin with the image depth of 4-5 cm. The inguinal region was examined laterally from the femoral vein until the 3 muscle layers consisting of the adductor longus, adductor brevis, and adductor magnus were identified with pectineus muscle medially along the inguinal crease. We allowed transducer tilting cranially 0°-20° angle until a fascial planes of the pectineus and adductor muscles were identified. A thick hyperechoic fascia was used as a targeting landmark for ONB, not focus on the obturator nerve itself (One between adductor longus and adductor brevis muscles for anterior branch, another between adductor brevis and adductor magnus muscles for posterior branch of obturator nerve). We excluded the case, in which three muscle layers were not identified definitely within the range. In the US-NS group, 22-gauge, 120-mm stimulating needle (Stimuplex insulated needle; D Plus B. Braun, Melsungen, Germany) attached to a nerve stimulator (Stimuplex HNS12;B. Braun, Melsungen, Germany) advanced via an ultrasound in-plane approach from lateral to medical direction to position the needle tip on the anterior branch. 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 (LA; 1.5% lidocaine + epi 1:200,000) were slowly injected within the muscle interface after negative aspiration, resulting in separation of these two muscles under real-time visualization. If there was misdistribution of LA spread (eg, spread into the muscle tissue), the needle was redirected until the correct spread of LA was visualized. The needle was withdrawn to the skin and reinserted to position the needle tip on the posterior branch. 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. After injection to the anterior and posterior branch, the stimulation current increased 1.0 mA, and needle was re-advanced as like Fig 1d for searching the residual muscle twitching. If muscle twitching was observed, then current was decreased to 0.5 mA, and confirming the muscle twitching on the sonogram at that current, 5ml of LA injected. We wrote that muscle twitching was occurred in what kind of muscles or fascias. In the US-IFI group, 22-gauge, 120-mm stimulating needle (Stimuplex insulated needle; D Plus B. Braun, Melsungen, Germany) without nerve stimulator advanced via an ultrasound in-plane approach from lateral to medical direction to position the needle tip on anterior branch. After negative aspiration, 10mL of LA were slowly injected within the muscle interface, resulting in separation of these two muscles under real-time visualization. The needle was withdrawn to the skin and reinserted to position the needle tip on posterior branch, another 5mL of LA was injected. After that, the needle was withdrawn to the skin and reinserted to the same spots, attached with nerve stimulator at the stimulation current 1.0 mA for confirming the block of anterior and posterior branch. If adductor muscle twitching was shown on sonogram, another 5mL of LA was injected, and it was documented as 'fail'. After that, needle was re-advanced as like US-NS group for searching the residual muscle twitching. It then went through the same process as the US-NS group, and we wrote that muscle twitching was occurred in what kind of muscles or fascias. We used only the nerve stimulator for confirming the success or fail of the ONB before the TURB surgery. Any needle redirection after withdrawing to the skin, was recorded as an additional needle pass. Before the injection, the image was captured as static, and the depth of anterior and posterior branch was measured by use of the built-in caliper of the ultrasound machine. We recorded ONB time, and time from the start of the sonographic examination until muscle layers identification was included. All blocks were performed by one anesthesiologist with more than 60 ONB experiences. After performing the ONB, patients were positioned in lithotomy position. Endoscopic resection of the neoplasm was started using a bipolar resectoscope (electrical current: 280 W) and endovesical irrigation with a normal saline solution. The surgery was performed by six surgeons randomly. We requested two assistants of urology, who didn't know the study groups (US-NS vs US-IFI) for obturator reflex grading. Obturator reflex grade was assessed by the scale of Lee's paper. Gr I: no movement or palpable muscle twitching, Gr II: palpable muscle twitching without movement, Gr III: slight movement of the thigh not interfering with the surgical procedure, and Gr IV: vigorous movement interfering with the surgical procedure.

Interventions

DEVICEnerve stimulator (stimuplex HNS12)

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

DEVICEultrasound

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

Sponsors

Gachon University Gil Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Success Rate of Ultrasound-guided Obturator Nerve Block With US-IFI Group and US-NS Groupup to 8 weeksWe 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'.

Secondary

MeasureTime frameDescription
Count the Number of Sub-divisions of Obturator Nerve at the Inguinal Creaseup to 8 weeksWe checked the additional intramuscular twitching with at least 3 times more needling after block the anterior and posterior branches in both groups. And documented that twitching occurred in what kind of muscles.

Participant flow

Recruitment details

dates of the recruitment period: January 2015 - May 2015 types of location: in the operating room

Participants by arm

ArmCount
US-IFI Group
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 brevis. 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and magnus, 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'.
31
US-NS Group
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 brevis. 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 0.3mA, 10mL of local anesthetics was injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and magnus. 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.
31
Total62

Baseline characteristics

CharacteristicUS-NS GroupTotalUS-IFI Group
Age, Continuous70 years
STANDARD_DEVIATION 11
69.2 years
STANDARD_DEVIATION 12.3
68 years
STANDARD_DEVIATION 14
American Society of Anesthesiologists physical status (ASA)
ASA I
11 participants18 participants7 participants
American Society of Anesthesiologists physical status (ASA)
ASA II
20 participants44 participants24 participants
Height (cm)166.3 cm
STANDARD_DEVIATION 6.3
165.2 cm
STANDARD_DEVIATION 7
164.1 cm
STANDARD_DEVIATION 7.6
Sex: Female, Male
Female
6 Participants12 Participants6 Participants
Sex: Female, Male
Male
25 Participants50 Participants25 Participants
Weight (kg)63.1 kg
STANDARD_DEVIATION 10.2
62.5 kg
STANDARD_DEVIATION 10.7
61.9 kg
STANDARD_DEVIATION 11.3

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 310 / 31
serious
Total, serious adverse events
0 / 310 / 31

Outcome results

Primary

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'.

Time frame: up to 8 weeks

ArmMeasureGroupValue (NUMBER)
US-IFI GroupSuccess Rate of Ultrasound-guided Obturator Nerve Block With US-IFI Group and US-NS Groupsuccess25 participants
US-IFI GroupSuccess Rate of Ultrasound-guided Obturator Nerve Block With US-IFI Group and US-NS Groupfail6 participants
US-NS GroupSuccess Rate of Ultrasound-guided Obturator Nerve Block With US-IFI Group and US-NS Groupsuccess31 participants
US-NS GroupSuccess Rate of Ultrasound-guided Obturator Nerve Block With US-IFI Group and US-NS Groupfail0 participants
Secondary

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

We checked the additional intramuscular twitching with at least 3 times more needling after block the anterior and posterior branches in both groups. And documented that twitching occurred in what kind of muscles.

Time frame: up to 8 weeks

ArmMeasureGroupValue (NUMBER)
US-IFI GroupCount the Number of Sub-divisions of Obturator Nerve at the Inguinal CreaseIn the adductor magnus muscle0 participants
US-IFI GroupCount the Number of Sub-divisions of Obturator Nerve at the Inguinal Creasein the fascia of anterior branch run2 participants
US-IFI GroupCount the Number of Sub-divisions of Obturator Nerve at the Inguinal Creasein the Adductor brevis muscle8 participants
US-IFI GroupCount the Number of Sub-divisions of Obturator Nerve at the Inguinal CreaseIn the fascia of posterior branch run2 participants
US-IFI GroupCount the Number of Sub-divisions of Obturator Nerve at the Inguinal CreaseIn the Pectineus muscle1 participants
US-NS GroupCount the Number of Sub-divisions of Obturator Nerve at the Inguinal CreaseIn the fascia of posterior branch run4 participants
US-NS GroupCount the Number of Sub-divisions of Obturator Nerve at the Inguinal Creasein the Adductor brevis muscle7 participants
US-NS GroupCount the Number of Sub-divisions of Obturator Nerve at the Inguinal CreaseIn the adductor magnus muscle1 participants
US-NS GroupCount the Number of Sub-divisions of Obturator Nerve at the Inguinal CreaseIn the Pectineus muscle2 participants
US-NS GroupCount the Number of Sub-divisions of Obturator Nerve at the Inguinal Creasein the fascia of anterior branch run1 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026