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CTRI Number  CTRI/2023/11/060126 [Registered on: 22/11/2023] Trial Registered Prospectively
Last Modified On: 21/11/2023
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 to compare the pain relief by two modalities pudendal and caudal block in children undergoing genital surgeries.  
Scientific Title of Study   Comparative study on perioperative analgesic efficacy of Ultrasound guided Pudendal neve block and caudal block in Pediatric patients undergoing penile procedures: a prospective randomised controlled non inferiority study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Venkata V Naidu Bongarala 
Designation  Junior Resident  
Affiliation  Post Graduate Institute of medical education and research 
Address  Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and research, sector 12

Chandigarh
CHANDIGARH
160012
India 
Phone  8095995533  
Fax    
Email  b.naidu777@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anudeep Jafra  
Designation  Associate Professor  
Affiliation  PGIMER CHANDIGARH 
Address  Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and research, sector 12

Chandigarh
CHANDIGARH
160012
India 
Phone  9888027699  
Fax    
Email  anu_gmch@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Anudeep Jafra  
Designation  Associate Professor  
Affiliation  PGIMER CHANDIGARH 
Address  Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and research, sector 12

Chandigarh
CHANDIGARH
160012
India 
Phone  9888027699  
Fax    
Email  anu_gmch@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and research, sector 12 
 
Primary Sponsor  
Name  Post Graduate Institute of Medical Education and Research 
Address  Nehru Hospital, 4th floor, B block, sector 12, Chandigarh  
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 Venkata V Naidu Bongarala  Post Graduate institute of medical education and research  operation theatre complex of advanced pediatric centre, Department of Anaesthesia Intensive Care
Chandigarh
CHANDIGARH 
8095995533

b.naidu777@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Post Graduate Institute of Medical Education and Research, thesis committee   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  ULTRASOUND GUIDED CAUDAL BLOCK  The patient is positioned in a lateral decubitus position. The sacral hiatus is identified and a midline view of the same is identified by a linear high-frequency. The two sacral cornua appear as reverse U-shaped hyperechoic structures (frog eye sign). In between, two hyperechoic band-like structures; the sacrococcygeal ligament superiorly and the dorsal bony surface of the sacrum inferiorly can be seen, with the sacral hiatus seen as a hypoechoic area in between. A 22-gauge needle is then inserted at 20 20-degree angle into the sacral hiatus in between the two cornua. Once the sacrococcygeal ligament is hit, giveway is felt. The view would be changed in such a way that a longitudinal view of the sacrum and its hiatus is obtained followed by needle advancement into the sacral canal in real-time guidance. After checking against accidental intravascular or intradural injection local anesthetic is given with real-time observation of frug being deposited at the target site. (Anterior displacement of posterior dura), 0.2% ropivacaine. duration of procedure 10 minutes. 
Intervention  ULTRASOUND GUIDED PUDENDAL NERVE BLOCK  This block involves the identification of the ischial spine, the patient is placed supine in a frog leg position the ultrasound linear high-frequency probe is kept at the ischial spine and lateral to the anal opening at 3 and 9 o clock positions. The ischiorectal fossa is identified in the middle of two shadows (laterally the ischial spine is seen as a hyperechoic semicircle with bone shadow below it and medially the rectal shadow), at the base of the ischiorectal fossa after application of doppler internal pudendal artery can be identified there runs the whole neurovascular bundle. the placement of local anesthetic(0.2% of ropivacaine) in the ischiorectal fossa close to the ischial spine leads to the spread of the drug to the neurovascular pudendal bundle after it had traversed through the Alcock’s canal and provides adequate analgesia for penile surgeries. The drug spread is seen as a hypoechoic area in the ischiorectal fossa. duration of procedure 10 minutes 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  7.00 Year(s)
Gender  Male 
Details  1.Age 2-7 years
2.ASA 1 and 2 patients
3.Undergoing penile surgeries( urethroplasty, chordee correction, and correction of urethrocutaneous fistula) under general anesthesia
 
 
ExclusionCriteria 
Details  1.Presence of a congenital heart disease
2.Presence of respiratory, renal, or hepatic dysfunction
3.ASA III and IV
4.Local infection
5.Coagulopathy
 
 
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 
Compare Between-group differences in the FLACC pain scores   6 hour 
 
Secondary Outcome  
Outcome  TimePoints 
Intraoperative and postoperative opioid consumption  0, 30min, 60min, 120min, 6, 10, 12,18,24 hrs 
Postoperative Pain Assessment (FLACC Scale)  0, 30min, 60min, 120min, 6, 10, 12,18,24 hrs 
Duration of post-anesthesia care unit stay  Up to 24 hours post-surgery 
Total analgesic consumption (acetaminophen/ketorolac)  at 24 hours 
Time to first rescue analgesia  Up to 24 hours post-surgery 
Complications of the block – hematoma, infection, Bradycardia, Hypotension, nausea, vomiting, block failure, duration of motor blockade.  Up to 24 hours post-surgery 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   02/12/2023 
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="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   Children undergo a variety of ambulatory urological surgeries, the commonest pathology being hypospadias. Similarly, chordee correction (orthoplasty), urethrocutaneous fistula closure, or genitoplasty are other common procedures done in children. All these procedures are associated with significant pain and require effective analgesia for better post-operative recovery.

Caudal epidural block is the commonest modality used for pain relief during intra and post-operative periods, by decreasing the release of stress hormones. However, the presence of anatomic variations, spine abnormalities, or in older children wherein the ligamentum flavum gets calcified makes the placement of the caudal epidural difficult. Also, there is a potential risk of rare complications like block failure (1.9%), infection, epidural hematoma, intravascular injection, intrathecal injection, motor blockade, and urinary retention, as depicted by the Pediatric regional anesthesia network. In the past there have been reports suggesting an association of caudal block (CB) to urethrocutaneous fistula, strictures, and wound dehiscence following hypospadias surgery.

Recently there is a trend towards using peripheral nerve blocks for pediatric urological procedures; the pudendal nerve block (PNB) is one of those, used for effective pain relief. Pudendal nerve supplies the perineum with somatosensory input for the penile region and arises from anterior rami of sacral segments (S2-4), it is a field block, wherein the local anesthetic is deposited adjacent to the terminal branches (perineal and dorsal penile nerve) and provides effective analgesia. It has been traditionally used for male genitalia surgeries, vaginal deliveries, chronic pain management, and hemorrhoidectomies. Although used for pain management in pediatric urological procedures, still there is limited data on its effectiveness, which warrants more randomized studies. It has been shown to reduce post-operative pain scores, decrease post-operative stay, and provide better parental satisfaction. Pudendal nerve block can be done by various approaches such as transgluteal,  transrectal, and transvaginal either through Alcock’s canal or by interligamentous plane. With the advent of ultrasound, inherent risks with an inadvertent vascular or rectal injury can be mitigated, adding to the safety profile of pudendal nerve block with more consistent analgesic coverage.

We hypothesize that ultrasound(US)-guided PNB is not inferior to CB in terms of the Face Legs Activity Cry Consolability behavioral scale(FLACC) score at the 6th postoperative hour (with a non-inferiority margin (NIM) of 2), in children presenting for penile procedures under General Anesthesia.

The research question for this study is to determine the meaningful postoperative pain relief in children aged between 2 yrs. to 7 yrs. presenting for penile surgeries under general anesthesia and comparing the US-guided PNB with a caudal block by comparing the FLACC pain score at the 6th postoperative hour (noninferiority of the pudendal block with a margin of difference of 2) to be conducted in the elective operation theatre in the advanced pediatric centre, PGIMER Chandigarh.


 
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