| CTRI Number |
CTRI/2026/02/103645 [Registered on: 11/02/2026] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing regional and general anesthesia to prevent sudden thigh jerks during bladder tumour surgery |
|
Scientific Title of Study
|
Comparison of bladder tumour resection under nerve stimulator guided obturator nerve block versus neuromuscular blockade |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abdul Qadir Boringwala |
| Designation |
DrNB resident |
| Affiliation |
Dr Babasaheb Ambedkar Hospital and medical college |
| Address |
Room no 1123, Department of Urology, Hospital Wing, Dr Baba Saheb Ambedkar Hospital and Medical College, Rohini Sector 6, New Delhi 110085
North West DELHI 110085 India |
| Phone |
9420607352 |
| Fax |
|
| Email |
Airechobabdulqadir@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Devesh Bhatia |
| Designation |
HOD Urology |
| Affiliation |
Dr Babasaheb Ambedkar Hospital and medical college |
| Address |
Ward 52, Department of Urology, Dr Baba Saheb Ambedkar Hospital and Medical College, Sector 6, Rohini, New Delhi 110085
North West DELHI 110085 India |
| Phone |
9311967481 |
| Fax |
|
| Email |
dr.bhatia.devesh@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Abdul Qadir Boringwala |
| Designation |
DrNB resident |
| Affiliation |
Dr Babasaheb Ambedkar Hospital and medical college |
| Address |
Room no 1123, Department of Urology, Hospital Wing, Dr Baba Saheb Ambedkar Hospital and Medical College, Rohini Sector 6, New Delhi 110085
North West DELHI 110085 India |
| Phone |
9420607352 |
| Fax |
|
| Email |
Airechobabdulqadir@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Baba Saheb Ambedkar Hospital and Medical College, Sector 6, Rohini, New Delhi, India 110085 |
|
|
Primary Sponsor
|
| Name |
Dept of Urology Dr Baba Saheb Ambedkar Hospital And Medical College |
| Address |
Room no 1123, Department of Urology, Dr Baba Saheb Ambedkar Hospital and Medical College, Rohini Sector 6, New Delhi 110085 |
| 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 Abdul Qadir Boringwala |
Dr Babasaheb Ambedkar Hospital and Medical College |
Room no 1123, Department of Urology, Hospital Wing, Dr Babasaheb Ambedkar Hospital and Medical College, Sector 6, Rohini, New Delhi 110085 North West DELHI |
9420607352
Airecho6abdulqadir@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Dr Baba Saheb Ambedkar Hospital and Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D303||Benign neoplasm of bladder, (2) ICD-10 Condition: D090||Carcinoma in situ of bladder, (3) ICD-10 Condition: C679||Malignant neoplasm of bladder, unspecified, (4) ICD-10 Condition: C672||Malignant neoplasm of lateral wallof bladder, (5) ICD-10 Condition: O||Medical and Surgical, (6) ICD-10 Condition: D494||Neoplasm of unspecified behavior of bladder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
General Anesthesia with Neuro Muscular Blockade |
In patients with lateral wall bladder tumours planned for TURBT the anesthesia would be General anesthesia with Neuro muscular blockade. Duration- from the start to the end of surgery, depend on tumour burden |
| Intervention |
Regional Anesthesia with nerve stimulator guided Obturator Nerve Block |
In patients with lateral wall bladder tumours planned for TURBT the anesthesia would be regional with Obturator nerve block performed on the side of the lesion using nerve stimulator. Duration- depends on tumour burden and the expected surgery duration. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with urinary bladder masses located on the lateral and/or posterolateral bladder wall
(confirmed on preoperative CT scan) undergoing Monopolar TURBT fit for surgery |
|
| ExclusionCriteria |
| Details |
Those unfit for either GA or regional anesthesia (RA)
Uncorrected coagulopathy
Allergy to local anaesthetic
Active infection at block site.
Pregnancy
Emergency procedures
Patient refusal |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Presence of obturator jerk (yes/no)
2.Count of Obturator Jerk events
3. management by the team (use of short bursts, change of cautery settings, switching to GA+NMB, deepening the NMB)
4. Completeness of resection: at the end of TURBT by the surgeon (complete / incomplete / uncertain)
5. Presence of detrusor muscle in specimen From histopathology report (Y/N).
6. Bladder perforation (Y/N) |
Intra Operatively- Bladder perforation, Presence of obturator jerk, Count of obturator jerk, management by the team for jerks
Completeness of resection by surgeon- immediately after the surgery
Presence of muscle in specimen- 15 days post operatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Anaesthesia Time: Time required to give Regional anaesthesia + ONB vs time required for GA + NMB till handover to operating surgeon, time for reversal of GA+NMB
2. Operative resection time: scope insertion to scope removal (minutes).
3. Change in haematocrit pre- & post-surgery
4. Complications of anesthesia (local site hematoma, inadvertent nerve injury, Intra vascular injury, postoperative local site pain, airway complications, pulmonary complications, post operative nausea vomiting &
anaphylactic reactions, aspiration)
5. length of hospital stays (days)
6. Need for Re-interventions, if any, within 48hrs |
1- From anesthesia start to handover to surgeon; reversal time at end of surgery.
2- During surgery
3- pre operative baseline & 6 hours post surgery
4- 24 hours
5- at time of discharge
6- 48 hours |
|
|
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)
|
30/03/2026 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Transurethral resection of bladder tumor TURBT is a common procedure for diagnosis and treatment of bladder cancer. Tumors located on the lateral and posterolateral bladder wall often cause intraoperative obturator nerve stimulation leading to sudden thigh adduction known as obturator jerk. This can result in bladder perforation, incomplete resection, and increased morbidity. Two main strategies are used to prevent this complication. One is obturator nerve block ONB performed with regional anesthesia and the other is general anesthesia with neuromuscular blockade GA NMB. While GA NMB reliably abolishes obturator reflex, it carries risks in elderly patients with comorbidities. ONB is safer in such patients but technically demanding. Evidence comparing surgeon performed nerve stimulator guided ONB with GA NMB in the Indian setting is limited.
This prospective randomized controlled trial will compare the effectiveness of ONB with regional anesthesia versus GA with NMB in patients undergoing TURBT for lateral and posterolateral bladder wall tumors. The primary outcome is incidence of obturator jerk. Secondary outcomes include completeness of resection, presence of detrusor muscle in specimen, bladder perforation, operative time, anesthesia time, complications, hospital stay, and need for reintervention. Ninety patients will be randomized equally into two groups. Results will help determine whether surgeon performed ONB is non inferior to GA NMB in preventing obturator jerk and improving surgical outcomes in routine practice |