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
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A study to compare the pain relief by two modalities pudendal and caudal block in children undergoing genital surgeries. |
Scientific Title of Study
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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
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Trial Acronym |
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Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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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 |
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Email |
b.naidu777@gmail.com |
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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 |
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Email |
anu_gmch@yahoo.co.in |
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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 |
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Email |
anu_gmch@yahoo.co.in |
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Source of Monetary or Material Support
|
Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and research, sector 12 |
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Primary Sponsor
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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 |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
Sites of Study
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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 |
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Details of Ethics Committee
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No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Post Graduate Institute of Medical Education and Research, thesis committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
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Intervention / Comparator Agent
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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 |
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Inclusion Criteria
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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
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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
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Method of Generating Random Sequence
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Computer generated randomization |
Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
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Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
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Outcome |
TimePoints |
Compare Between-group differences in the FLACC pain scores |
6 hour |
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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 |
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Target Sample Size
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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
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Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
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Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
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N/A |
Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
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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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