| CTRI Number |
CTRI/2025/10/096511 [Registered on: 28/10/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the efficacy of ultrasound (US) guided Obturator nerve block versus Pericapsular Nerve Group (PENG) block in preventing sudden jerks in patients undergoing surgery for bladder mass under spinal anaesthesia. |
|
Scientific Title of Study
|
To compare the efficacy of ultrasound (US) guided Obturator nerve block versus Pericapsular Nerve Group (PENG) block in preventing adductor spasm in patients undergoing transurethral resection of postero-lateral bladder mass under spinal anaesthesia: a prospective, randomised, single blinded, controlled clinical study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swati KV |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Major OT B block, 4th floor, Department of Anaesthesiology, AIIMS Raipur, Tatibandh
Raipur CHHATTISGARH 492099 India |
| Phone |
9901967469 |
| Fax |
|
| Email |
swativijapurkar24@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Subrata Kumar Singha |
| Designation |
Professor and Head |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Major OT B block, 4th floor, Department of Anaesthesiology, AIIMS Raipur, Tatibandh
Raipur CHHATTISGARH 492099 India |
| Phone |
8518881767 |
| Fax |
|
| Email |
subratsingh@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Subrata Kumar Singha |
| Designation |
Professor and Head |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Major OT B block, 4th floor, Department of Anaesthesiology, AIIMS Raipur, Tatibandh
Raipur CHHATTISGARH 492099 India |
| Phone |
8518881767 |
| Fax |
|
| Email |
subratsingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Tatibandh Raipur, Chhattisgarh 492099 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Raipur |
| Address |
AIIMS, Tatibandh Raipur Chattisgarh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Swati KV |
All India Institute of Medical Sciences |
AIIMS, Tatibandh, RAIPUR, CHHATTISGARH 492099 Raipur CHHATTISGARH |
9901967469
swativijapurkar24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Obturator Nerve Block |
After achieving adequate sensory and motor blockade post spinal anesthesia, under all aseptic precautions, Group O will receive ultrasound (US) guided Obturator nerve block with 20 mL of 0.5% Bupivacaine |
| Intervention |
Pericapsular Nerve Group (PENG) block |
After achieving adequate sensory and motor blockade post spinal anesthesia, under all aseptic precautions, Group P will receive ultrasound (US) guided PENG block with 20 mL of 0.5% Bupivacaine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Males and Females aged 18-75 years
ASA PS class I, II and III
Patients scheduled for trans-urethral resection of posterolateral bladder mass
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Allergy to study drug
Deranged coagulation profile
Platelet count less than 80,000
Block site infection
Patient in sepsis
Bladder mass not in posterolateral region
Any other contraindication for spinal anaesthesia
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Occurrence of Adductor Spasm (Yes/No)
|
During the surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Conversion to General Anaesthesia (Yes/No)
Quadriceps Weakness – Measured by MRC muscle grading at 0, 2, 4, & 6 hours postoperatively
Bladder Perforation (Yes/No)
Pain scores – Numerical Rating Scale (NRS)
Return to Grade 5 Muscle Strength – Time taken to recover full quadriceps strength
|
During the surgery
0,2,4,6 hours postop |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="62" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| Date of Study Completion (India) |
26/02/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
After approval by the Institute Ethics Committee, the eligibility criteria (inclusion and the exclusion) will be adhered to strictly for selection of study population. Written informed consent will be obtained from the patients undergoing elective trans-urethral resection of posterolateral bladder mass surgery under spinal anaesthesia after explaining the study protocol to them. The patients will be assessed for medical and surgical history, general and systemic examination, airway examination and investigations such as complete blood picture, renal function test, liver function test and coagulation profile. On the day of surgery, in the preoperative area, baseline vitals such as Heart rate (HR), Mean arterial pressure (MAP), and Oxygen saturation (SpO2) will be noted. The patients will be randomly allocated to one of the two groups. Based on the number chosen and the allotted group, patients will be randomly divided into Group P and Group O. The patient will then be taken into the operation theatre and standard ASA monitors will be connected. After noting down the baseline vitals in the operation theatre, spinal anesthesia will be given, and the level of the sensory and motor blockade will be noted. The onset of sensory blockade will be assessed by the appearance of tingling and numbness sensation and the maximum level of sensory blockade will be assessed using pin prick test. The motor blockade will be assessed using the Modified Bromage scale. After achieving adequate sensory and motor blockade, under all aseptic precautions, Group P will receive ultrasound (US) guided PENG block with 20 mL of 0.5% Bupivacaine and Group O will receive US guided obturator nerve block with 20 mL of 0.5% Bupivacaine. Intraoperatively, presence of adductor jerk will be noted by the surgeon and the anesthesiologist. The patient will be followed up for 6 hours postoperatively and quadriceps muscle strength by MRC medical grading at postoperative 0, 2, 4, 6 hours and return to Grade 5 will be documented. Complications like perforation of the bladder, conversion to general anaesthesia due to failure of the block and hypotension, bradycardia, low back ache, post dural puncture headache and urinary retention due to spinal anaesthesia will be noted. Any adverse event before, during and after the procedure will be treated appropriately.
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