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CTRI Number  CTRI/2024/03/064341 [Registered on: 18/03/2024] Trial Registered Prospectively
Last Modified On: 12/03/2024
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 clinical study to compare among three types of nerve blocks to decrease pain during and after surgeries of penis in children 
Scientific Title of Study   Comparison among Ultrasound guided Pudendal Nerve Block Dorsal Penile Nerve Block and Caudal Block for perioperative analgesia on pediatric patients undergoing penile surgeries 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Saikat Das 
Designation  Junior Resident 
Affiliation  AIIMS Patna 
Address  5th floor IPD building B5A OT complex AIIMS PATNA Phulwarisharif Patna Bihar 801507

Patna
BIHAR
801507
India 
Phone  08017808002  
Fax    
Email  dassaikt25@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shagufta Naaz  
Designation  Additional Professor 
Affiliation  AIIMS Patna 
Address  Room no. 501 5th floor IPD building B5A OT complex AIIMS Patna Phulwarisharif Patna Bihar 801507

Patna
BIHAR
801507
India 
Phone  7765937919  
Fax    
Email  drshaguftanaaz@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shagufta Naaz  
Designation  Additional Professor 
Affiliation  AIIMS Patna 
Address  Room no. 501 5th floor IPD building B5A OT complex AIIMS Patna Phulwarisharif Patna Bihar 801507

Patna
BIHAR
801507
India 
Phone  7765937919  
Fax    
Email  drshaguftanaaz@gmail.com  
 
Source of Monetary or Material Support  
All India Institute Of Medical Sciences Patna 
 
Primary Sponsor  
Name  All India Institute Of Medical Sciences Patna 
Address  IPD building 5th floor OT complex AIIMS Patna Phulwarisharif Patna Bihar 801507 
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 Saikat Das  All India Institute Of Medical Sciences Patna  Room no. 501 5th floor IPD building OT complex Department of Anaesthesiology, AIIMS Patna Phulwarisharif Patna Bihar 801507
Patna
BIHAR 		 08017808002

dassaikt25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee All India Institute Of Medical Sciences Patna  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q648||Other specified congenital malformations of urinary system, (2) ICD-10 Condition: N488||Other specified disorders of penis, (3) ICD-10 Condition: N368||Other specified disorders of urethra, (4) ICD-10 Condition: N364||Urethral functional and muscular disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Caudal block  Caudal block will be performed under ultrasound guided technique in the lateral decubitus position and a Local anesthetics inj. bupivacaine 0.25 percent will be given as 0.5ml per kg after confirming the absence of blood and cerebrospinal fluid by aspiration after induction and patient will be followed for 24 hours postoperatively 
Intervention  Dorsal Penile nerve block  Dorsal penile nerve will be achieved in the supine position by using linear probe putting on the symphysis pubis & perforating the Scarpa’s fascia with 25G needle under ultrasound guided technique and injecting 0.25percent bupivacaine mixture of 0.3ml per kg volume on the midline into the dorsal base of penis between the pubis and the penis under Scarpa’s fascia after induction of anesthesia and the patient will be followed for 24 hours postoperatively  
Intervention  Pudendal nerve block  Block will be performed in lithotomy position and needle will be inserted under ultrasound guided technique from inferomedial aspect of bilateral ischial tuberosities and Inj. Bupivacaine 0.25 percent mixture of 0.3ml per kg will be administered after induction of anesthesia and the patient will be followed for 24 hours postoperatively  
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  7.00 Year(s)
Gender  Male 
Details  1-7 years of age
ASA I-II
Undergoing elective surgery 
 
ExclusionCriteria 
Details  Patients with known allergies to the study drug
Coagulopathy
Patients with neurological disorders
Patients with spinal deformities
Emergency surgeries
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate postoperative pain scores during 24 hours at different time points (0h, 2h,
4h, 6h, 12h, 24h) using FLACC pain scale (Face, Leg, Activity, Cry and Consolability)
delivering postoperative analgesia.
 		 0h, 2h, 4h, 6h, 12h, 24h
 
 
Secondary Outcome  
Outcome  TimePoints 
To assess perioperative opioid consumption among the three groups during 24 hours  within 24 hours 
Time to first rescue analgesia  within 24 hours 
To assess parent’s satisfaction with perioperative analgesia  after 24 hours 
 
Target Sample Size   Total Sample Size="114"
Sample Size from India="114" 
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   Phase 4 
Date of First Enrollment (India)   29/03/2024 
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 Yet Recruiting 
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   Pediatric penile surgery done under general anesthesia requires adequate analgesia. Selecting an efficient regional anesthesia for penile surgery on pediatric patients is crucial for lowering postoperative discomfort, cutting down on systemic opioid use and promoting early recovery. We expect to find out the optimal regional anesthesia/nerve block method in the peri operative period for pediatric patients undergoing penile surgeries.

After premedication with midazolam 0.1mg/kg, the patients will be taken into the operating room for application of all ASA monitoring and anesthesia induction will be achieved with Fentanyl (2mcg/kg), Propofol (2mg/kg) & sevoflurane in titrated dose. Laryngeal Mask Airways or Endotracheal tube of the appropriate size to be inserted after muscle relaxant administration as Atracurium (0.5mg/kg).

In Dorsal Penile nerve block group (A- group/ DPNB), Dorsal penile nerve will be achieved in the supine position. After skin sterilization, by using linear probe putting on the symphysis pubis & perforating the Scarpa’s fascia with 25G needle under ultrasound guided technique, injecting 0.25% bupivacaine mixture of 0.3ml/kg volume on the midline into the dorsal base of penis, between the pubis and the penis under Scarpa’s fascia.
In Pudendal nerve block group (B- group/ PDNB), block will be performed in lithotomy position. After the appropriate skin sterilization 22-24G needle, 50-100 mm will be inserted under ultrasound guided technique from inferomedial aspect of ischial tuberosities. Inj. Bupivacaine will be administered as a 0.25% mixture of 0.3ml/kg. This procedure will be performed bilaterally. In Caudal block group (C-group/ CDB), caudal block will be performed under ultrasound guided technique in the lateral decubitus position, the sacral hiatus area will be sterilized with an antiseptic solution and a 24G needle will be used for puncture. Local anesthetics inj. Bupivacaine 0.25% will be given as 0.5ml/kg after confirming the absence of blood and cerebrospinal fluid by aspiration.

The FLACC pain scale will be used to gauge the patients’ level of discomfort. The FLACC postoperative scores at 0 minutes, 2 hour, 4 hours, 6 hours, 12 hours and 24 hours will be noted. Paracetamol 15 mg/kg will be given intravenously at an interval of 6 hours, the first dose to be given intraoperatively. A rescue analgesic to patients will be administered with a score of more than 4, in the form of Inj. Tramadol 1-1.5 mg/kg. In case the analgesia is still inadequate after 30 minutes, inj. Morphine 0.05 mg/kg will be given as and the three techniques will be compared based on FLACC pain scale and with regard to analgesic consumption.




 
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