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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  
Name  Address 
NIL  Nil 
 
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  
Status 
Not Applicable 
 
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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