UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022716 |
|---|---|
| Receipt number | R000026171 |
| Scientific Title | Comparison of classic approach and sub-branch approach during sono-guided obturator nerve block |
| Date of disclosure of the study information | 2017/06/30 |
| Last modified on | 2019/12/12 16:04:35 |
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Basic information
Public title
Comparison of classic approach and sub-branch approach during sono-guided obturator nerve block
Acronym
sono-guided obturator nerve block:sub-branch approach
Scientific Title
Comparison of classic approach and sub-branch approach during sono-guided obturator nerve block
Scientific Title:Acronym
sono-guided obturator nerve block:sub-branch approach
Region
| Asia(except Japan) |
Condition
Condition
bladder cancer
Classification by specialty
| Urology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Transurethral resection of bladder tumor (TURB) has been essential treatment for bladder tumors. Direct electrical stimulation of an obturator nerve (ON) during TURB procedures can trigger an inadvertent adductor muscle spasm, which can cause a serious complication like bladder perforation. Spinal anesthesia with selective obturator nerve block (ONB) can be an excellent anesthesia for TURB.
Basically, ON has been known to be 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 crease. Therefore, ONB has been performed with anterior or posterior (main) branch block at the inguinal crease level. But we became discovered that adductor muscle spasm can occur even in complete main branches block state through our experiences (complete main branches block was confirmed with nerve stimulator).
The main branch of ON has a multiple branching pattern, and subdivisions are extensively distributed among the adductor muscles. Therefore, we suppose that unblocked sub-branches can cause the adductor muscle spasm, even after main branches block. So we suppose that sub-branch block added with main branches block can increase efficacy of classic ONB at the inguinal crease. Incomplete ONB can result into serious bladder perforation, and it is enough damage to patient even in one case. So sub-branch approach can also increase safety of patients.
We chose the fan-like injection technique for blocking the subdivisions, which might be located through the adductor longus, brevis, magnus, pectineus muscles or another point of fascias where main branches pass through. We called it as sub-branch approach of the ONB.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
success rate of sono-guided ONB with classic approach and sub-branch approach (evaluation periods: about 6 months)- obturator reflex grade(I-IV)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Interventions: sub-branch approach
A 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) is advanced using an ultrasound in-plane approach from lateral to medial to position the needle tip at the fascia of posterior branch. The neurostimulation current starts at 0.5 mA. If adductor muscle twitching is observed even at 0.3 mA, 10 ml of local anesthetic (LA; 1.5% lidocaine + epinephrine 1:200,000) is slowly injected after negative aspiration, and we identify the separation of the adjacent muscles. The needle is then positioned at the fascia of anterior branch, and 10 ml of LA is injected in the same manner. 15 min. After main branches block, the needle is re-advanced fan-likely (needling at least 3 more times) to search for sub-branch of ON (2.0 mA). If twitching is observed on ultrasound view (0.3 - 0.5 mA), 3 ml of LA is injected.
Interventions/Control_2
Control: classic approach
An anterior and posterior branches block is performed in the same manner with sub-branch block.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
all patients anticipating transurethral resection of bladder tumors with American Society of Anesthesiologists physical status(ASA) I or II
Key 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
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Mi Geum |
| Middle name | |
| Last name | Lee |
Organization
Gachon University Gil Medical Center
Division name
The Anesthesiology and Pain Medicine
Zip code
21565
Address
Namdong-gaero 774 beon-gil, Namdong-gu, Incheon, 21565, South Korea
TEL
82-32-460-3636
mikeum2@gilhospital.com
Public contact
Name of contact person
| 1st name | Mi Geum |
| Middle name | |
| Last name | Lee |
Organization
Gachon University Gil Medical Center
Division name
The Anesthesiology and Pain Medicine
Zip code
21565
Address
Namdong-gaero 774 beon-gil, Namdong-gu, Incheon, 21565, South Korea
TEL
82-32-460-3636
Homepage URL
mikeum2@gilhospital.com
Sponsor or person
Institute
Gachon University Gil Medical Center
Institute
Department
Personal name
Funding Source
Organization
Gachon University Gil Medical Center
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gachon University Gil Medical Center
Address
Namdong-gaero 774 beon-gil, Namdong-gu, Incheon, 21565, South Korea
Tel
82-32-460-3636
mikeum2@gilhospital.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
70
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 13 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 10 | Day |
Date of closure to data entry
| 2019 | Year | 09 | Month | 16 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 13 | Day |
Last modified on
| 2019 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026171
