| CTRI Number |
CTRI/2025/12/098597 [Registered on: 08/12/2025] Trial Registered Prospectively |
| Last Modified On: |
07/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To compare the pain relief by adding clonidine to suprazygomatic maxillary nerve blocks for pediatric cleft lip and palate surgeries |
|
Scientific Title of Study
|
A randomized controlled trial to assess the efficacy of clonidine as an adjunct to suprazygomatic maxillary nerve blocks for pediatric cleft lip and palate 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 |
Dr Vrushali C Ponde |
| Designation |
Consultant |
| Affiliation |
Holy Spirit Hospital, Mumbai |
| Address |
Holy Spirit Hospital
Mahakali caves road, Sher E Punjab colony, Andheri East, Mumbai
Maharashtra, 400093
Mumbai
MAHARASHTRA
400093
India |
| Phone |
09819886502 |
| Fax |
|
| Email |
vrushaliponde@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vrushali C Ponde |
| Designation |
Consultant |
| Affiliation |
Holy Spirit Hospital, Mumbai |
| Address |
Holy Spirit Hospital
Mahakali caves road, Sher E Punjab colony, Andheri East, Mumbai
Maharashtra, 400093
Mumbai
MAHARASHTRA
400093
India |
| Phone |
09819886502 |
| Fax |
|
| Email |
vrushaliponde@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vrushali C Ponde |
| Designation |
Consultant |
| Affiliation |
Holy Spirit Hospital, Mumbai |
| Address |
Holy Spirit Hospital
Mahakali caves road, Sher E Punjab colony, Andheri East, Mumbai
Maharashtra, 400093
Mahakali caves road, Sher E Punjab colony, Andheri East, Mumbai
Mumbai
MAHARASHTRA
400093
India |
| Phone |
09819886502 |
| Fax |
|
| Email |
vrushaliponde@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Surya Children Hospital First floor OT complex. 101-102 Mangal Ashirvad S V road santacruz west Mumbai 400054 |
|
|
Primary Sponsor
|
| Name |
Childrens Anaesthesia Services Mumbai |
| Address |
C/ O Surya Childrens Hopsital, S V Road, Santacruz West Mumbai- 400054 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Dr Vrushali C Ponde |
Holy Spirit Hospital |
Holy Spirit Hospital
Mahakali caves road, Sher E Punjab colony, Andheri East, Mumbai Maharashtra, 400093
Mumbai
MAHARASHTRA
400093
India
Mumbai
MAHARASHTRA |
09819886502
vrushaliponde@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Holy spirit Hospital Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P968||Other specified conditions originating in the perinatal period, (2) ICD-10 Condition: Q379||Unspecified cleft palate with unilateral cleft lip, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bilateral suprazygomatic maxillary nerve block |
Bilateral suprazygomatic maxillary nerve block using 0.25% levobupivacaine (0.15 mL/kg per side) |
| Intervention |
Bilateral suprazygomatic maxillary nerve block with additve (single shot) |
Bilateral suprazygomatic maxillary nerve block using 0.25% levobupivacaine (0.15 mL/kg per side) and clonidine as an additive (single shot) |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1/2 with Cleft palate and/lip |
|
| ExclusionCriteria |
| Details |
ASA 3 /4 with other malformations |
|
|
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 get the percentage of patients requiring supplemental analgesia (rescue dose) within 4 hours postoperatively using the FLACC score. |
4 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain scores 0-24 h (Pain scale (FLACC), food intake during 12-24 hours postop, Duration of sleep5, and sedation scores during postop period, complications like POV, bradycardia, emergence delirium etc., Length of hospital stay (24 hours to 48 hours or more), Wound healing on the 5 th day: A: excellent. b: satisfatctory. c: Poor. |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
23/12/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Suprazygomatic maxillary nerve block SZMNB was used for analgesia in pediatric cleft palate surgery 1 The use of bilateral SZMNB has in a previous study been reported to reduce the need of intraoperative fentanyl and volatile agent 2 but did not report on postoperative pain We have planned this study to evaluate the effectiveness of clonidine as an adjunct to suprazygomatic approach maxillary nerve block for pediatric patients undergoing cleft lip and palate surgeries Eligible patients will be screened and informed written consent will be obtained from parents or caregivers before participation Randomization will be performed using computer generated random numbers or sealed envelopes Participants will be allocated to one of two study groups The clonidine group will receive 2 mcgkg of clonidine added to 025 percent levobupivacaine administered at a volume of 015 mLkg per side
The placebo group will receive the same volume of saline added to 025 percent levobupivacaine The study will terminate at 24 hours postoperatively with follow up on Day 5 for wound healing assessments References
1 Mesnil M Dadure C Captier G Raux O Rochette A Canaud N Sauter M Capdevila X A new approach for peri operative analgesia of cleft palate repair in infants the bilateral suprazygomatic maxillary nerve block Paediatr Anaesth 2010 20 3439
2 Chiono J Raux O Bringuier S Sola C Bigorre M Capdevila X Dadure C Bilateral suprazygomatic maxillary nerve block for cleft palate repair in children a prospective randomized double blind study versus placebo Anesthesiology 2014 120 13629 |