| CTRI Number |
CTRI/2022/01/039492 [Registered on: 17/01/2022] Trial Registered Prospectively |
| Last Modified On: |
15/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Using ultrasound proximal and distal obturator nerve block given for compair success rate of block in Transurethral resection of lateral wall bladder tumour |
|
Scientific Title of Study
|
Comparison of proximal versus distal approach for ultrasound guided obturator nerve block for prevention of adductor spasm in patients undergoing transurethral resection of bladder tumour |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vinod Kumar |
| Designation |
Postgraduate Student |
| Affiliation |
Vardaman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care. Second floor, Urology Operation Theatre Super Speciality Block Safdarjung Hospital and Vardaman Mahavir Medical College, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
7011670886 |
| Fax |
|
| Email |
pranjalyad2013@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dharam Singh Meena |
| Designation |
Professor and Consultant |
| Affiliation |
Vardaman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care. Second floor, Urology Operation Theatre Super Speciality Block Safdarjung Hospital and Vardaman Mahavir Medical College, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9910277131 |
| Fax |
|
| Email |
dharams_meena@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinod Kumar |
| Designation |
Postgraduate Student |
| Affiliation |
Vardaman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care. Second floor, Urology Operation Theatre Super Speciality Block Safdarjung Hospital and Vardaman Mahavir Medical College, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
pranjalyad2013@gmail.com |
|
|
Source of Monetary or Material Support
|
| Safdarjung Hospital and Vardaman Mahavir Medical College, New Delhi. India |
|
|
Primary Sponsor
|
| Name |
Safdarjung Hospital and Vardaman Mahavir Medical College New Delhi India |
| Address |
Department of Anaesthesia and Intensive Care. Second floor, Urology Operation Theatre Super Speciality Block Safdarjung Hospital and Vardaman Mahavir Medical College, New Delhi |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vinod Kumar |
Safdarjung Hospital and Vardaman Mahavir Medical College, New Delhi |
Department of Anaesthesia and Intensive Care. Second floor, Urology Operation Theatre Super Speciality Block Safdarjung Hospital and Vardaman Mahavir Medical College, New Delhi
New Delhi
DELHI |
07011670886
pranjalyad2013@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C672||Malignant neoplasm of lateral wallof bladder, (2) ICD-10 Condition: N328||Other specified disorders of bladder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Obturator nerve block by distal approach. |
In the distal group(D group), the ultrasound transducer will be placed along the inguinal crease and the femoral vessels will be identified. Tracing the ultrasound probe medially the pectineus, adductor longus, adductor brevis, and adductor magnus muscles will be identified by the classic Y shape. Using a 24 gauge needle, 2ml of 2% lignocaine will be administered 1 cm away from the lateral edge of the transducer. A 22-gauge, 80-mm sonoplex needle will be inserted from lateral to medial in an in-plane approach to place the tip at a hyperechoic structure of the fascial interface between the adductor longus and adductor brevis muscles. After negative aspiration, 5 mL of 0.5% ropivacaine will be injected. Then, the needle will be withdrawn and reinserted to be positioned at the fascial plane between adductor brevis and adductor magnus muscles, and 5 mL of 0.5% ropivacaine will be injected after negative aspiration. |
| Comparator Agent |
Obturator nerve block by proximal approach. |
In proximal group (P group), the transducer placed will be placed on the medial aspect of the inguinal crease and will be tilted 40–50 degrees cranially until a hyperechoic structure deep and lateral to the pectineus is visualized (inferior margin of the superior pubic ramus). The intermuscular fascia deep to the pectineus muscle separating it from the obturator externus muscle will be identified. Using a 24 gauge needle 2 ml of 2% lignocaine will be given 1 cm away from the lateral edge of the transducer. A 22 G , 80 mm Sonoplex needle will be inserted in this fascia under ultrasound guidance in an inplane direction, from lateral to medial and 10 mL of 0.5% ropivacaine will be injected after negative aspiration |
| Intervention |
Prevention of adductor jerk/ spasm during the surgery. |
In Urologic surgery the TURBT is done for non muscle invasive bladder tumour under subarachnoid block. However in resection of lateral wall bladder tumour, obturator reflex is not prevented reliably under spinal anaesthesia, due to obturator nerve stimulation resulting in adductor muscle spasm. For prevention of obturator nerve stimulation obturator nerve block given.Adductor muscle power will be assessed after 15 minutes of block, After the successful block spinal anaesthesia will be given. Patient will be monitored throughout the surgery using standard monitoring. Success rate will be determined by the absence of adductor jerk/ spasm during the surgery. Intraoperatively, if any jerk are observed and leads to discontinuation of surgery, then general anaesthesia with muscle relaxant will be given and it will be considered as failure of technique. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients of age group 18 and above years, of either gender fulfilling the criterion of American society of anaesthesiologist physical classification classes I-III scheduled for unilateral transurethral resection of lateral bladder wall tumour under spinal anaesthesia and requiring obturator nerve block. |
|
| ExclusionCriteria |
| Details |
Pre existing obturator nerve injury or adductor muscle weakness
Local anaesthetic allergy.
Coagulopathy.
Inguinal lymphadenopathy.
Infection or scar at the needle insertion site.
•Neuromuscular disorder
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the success rate of proximal versus distal approach of ultrasound guided obturator nerve block for prevention of adductor spasm in patients undergoing transurethral resection of lateral wall bladder tumour under spinal anaesthesia by the absence of adductor muscle jerk during the surgery. |
During surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare proximal versus distal approach of ultrasound guided obturator nerve block in patients undergoing transurethral resection of lateral wall bladder tumour under spinal anaesthesia with respect to-
Adductor muscle power after the block
Block performance time
Number of needle passes
Surgeon satisfaction
|
During surgery |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/01/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [Pranjalyad2013@gmail.com].
- For how long will this data be available start date provided 15-01-2022 and end date provided 22-12-2025?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Pranjalyad2013@gmail.com
|
|
Brief Summary
|
Patient assessed for eligibility, Preoperative assessement and prepration will be done, Written informed consent from patient/ guardian will be taken Patient will be shifted to operation theatre and monitors attached. Baseline vitals will be noted. Intravenous line established and i.v injection fentanyl 0.5 mcg/kg will be given to each patient. Randomisation into two groups- proximal group (P group) or distal (D group) will be done Ultrasound guided obturator nerve block will be performed by proximal or distal approach . Block performance time ,number of needle passes, complications will be noted. Patient will be monitored.Adductor muscle power will be assessed and graded after 15 minutes. spinal anesthesia will be given with 2.5 ml of 0.5% bupivacaine with 10 mcg fentanyl. After confirming the sensory blockade at T-10 level surgery will be started Success rate will be determined by the absence of adductor jerk/ spasm during the surgery. If any jerks are observed and leads to discontinuation of surgery , it will be noted and general anaesthesia will be given. Surgeon satisfaction will be noted at end of surgery |