| CTRI Number |
CTRI/2025/06/088744 [Registered on: 12/06/2025] Trial Registered Prospectively |
| Last Modified On: |
12/06/2025 |
| 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
|
Comparision of analgesic efficacy of bupivacaine drug with and without an additive named dexmedetomidine in intervention of pudendal block in pediatric participants undergoing perineal procedures. |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of dexmedetomidine as an adjuvant to 0.25% Bupivacaine vs. Plain 0.25% bupivacaine in ultrasound-guided pudendal nerve block in children undergoing perineal procedures: A prospective, randomized comparative 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 |
NUNNA HANNAH MOUNIKA |
| Designation |
Fellow in pediatric anaesthesia |
| Affiliation |
Sri ramachandra institute of higher education and research |
| Address |
Department of Anesthesiology
Sri ramachandra institute of higher education and research
Porur
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9493718157 |
| Fax |
|
| Email |
c125hannah@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ARUNA PARAMESWARI |
| Designation |
Professor and Head of the Department |
| Affiliation |
Sri ramachandra institute of higher education and research |
| Address |
Department of Anaesthesia
Sri ramachandra institute of higher education and research
Porur
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9493718157 |
| Fax |
|
| Email |
hod.anaesthesiology@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
NUNNA HANNAH MOUNIKA |
| Designation |
Fellow in Paediatric Anaesthesia |
| Affiliation |
Sri ramachandra institute of higher education and research |
| Address |
Department of Anesthesia
Sri ramachandra institute of higher education and research
Porur
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9493718157 |
| Fax |
|
| Email |
c125hannah@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of higher education and research |
| Address |
Department of Anesthesia
Sri ramachandra institute of higher education and research
Porur
Chennai
600116 |
| 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 |
| NUNNA HANNAH MOUNIKA |
Sri ramachandra institute of higher education and research |
Department of Anesthesia
Sri Ramachandra institute of higher education and research
Porur
Chennai
600116
Chennai
TAMIL NADU |
9493718157
c125hannah@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Committee for students proposals,SRIHER (DU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ultrasound guided pudendal block |
comparing efficacy of plain 0.25% bupivacaine with dexmeditomidine as adjuvant to 0.25% bupivacaine in ultrasound guided pudendal block in paediatric urological procedures |
| Comparator Agent |
ultrasound guided pudendal block with dexmeditomidine as comparator agent |
compare plain bupivacaine 0.25% and dexmeditomidine as adjuvant to 0.25% bupivacaine in ultrasound guided pudendal block for paediatric urological surgeries |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Age 6 months to 7 years
ASA physical status I- II
Scheduled to undergo elective perineal surgeries- circumcision, hypospadias, PUJ fulguration, chordee repair |
|
| ExclusionCriteria |
| Details |
Parent refusal
History of allergic reactions to local aesthetics
Bleeding diathesis
Rash or infection at the injection site
Anatomical spinal abnormality
Liver diseases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Determine the effects of the intervention as duration of analgesia as first time to rescue analgesic |
timeline assessed at baseline, every 5minutes till 90 minutes intraoperatively and till 24 hours post operatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
success of block
Quality of recovery score |
effectiveness of block and patient satisfaction in analgesic management |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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
|
N/A |
|
Date of First Enrollment (India)
|
24/06/2025 |
| 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="0"
Months="3"
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
|
Perioperative pain management in pediatric patients is essential for enhancing recovery and minimizing postoperative complications. Pudendal nerve block, a regional anesthesia technique, is increasingly preferred for perineal surgeries as it provides targeted analgesia, reduces systemic opioid use, and minimizes complications associated with central neuraxial blocks, such as dural puncture, motor block, and urinary retention. Among local anesthetics, bupivacaine is widely used for its efficacy and prolonged action. However, the addition of adjuvants like dexmedetomidine has shown promise in enhancing analgesia. in this study, we are comparing the efficacy of dexmeditomidine as an adjuvant to 0.25% bupivacaine. |