| CTRI Number |
CTRI/2025/02/080944 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the pain-relieving effect of both sided sphenopalatine ganglion block using ultrasound versus those without block in cleft palate surgery. |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of ultrasound guided bilateral sphenopalatine ganglion block versus no block in cleft palate surgery: A randomised controlled trial |
| 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 Dheeraj Kumawat |
| Designation |
junior resident |
| Affiliation |
All India Institute Of Medical Science, Patna |
| Address |
B5A OT Complex IPD building Department of Anaesthesiology All India Institute of Medical Sciences Patna Phulwarisharif Patna
BIHAR India
Patna
BIHAR
801507
India
Patna
BIHAR
801507
India |
| Phone |
9079325301 |
| Fax |
|
| Email |
kumawatdraj97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shagufta Naaz |
| Designation |
Additional professor |
| Affiliation |
All India Institute of Medical Sciences Patna |
| Address |
Room no. 501 B5A OT Complex IPD building Department of
Anaesthesiology All India Institute of Medical Sciences Patna
Phulwarisharif Patna BIHAR India
Patna
BIHAR
801507
India
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 |
All India Institute of Medical Sciences Patna |
| Address |
Room no. 501 B5A OT Complex IPD building Department of
Anaesthesiology All India Institute of Medical Sciences Patna
Phulwarisharif Patna BIHAR India
Patna
BIHAR
801507
India
Patna
BIHAR
801507
India |
| Phone |
7765937919 |
| Fax |
|
| Email |
drshaguftanaaz@gmail.com |
|
|
Source of Monetary or Material Support
|
| B5A OT Complex IPD building Department of Anaesthesiology All India Institute of Medical Science, Patna, Phulwarisharif pin 801507, India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Patna |
| Address |
All India Institute of Medical Sciences Patna, Phulwarisharif, Patna,
Bihar, PIN 801507 |
| Type of Sponsor |
Government medical college |
|
|
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 Dheeraj Kumawat |
All India Institute of Medical Sciences |
B5A OT Complex IPD building Department of Anaesthesiology All India Institute of Medical Science, Patna, Phulwarisharif pin 801507, India
Patna
BIHAR |
9079325301
kumawatdraj97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences Patna Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group C |
this group will recieve intravenous injection of Fentanyl(2mcg/kg), Propofol(2mg/kg),Atracurium(0.5mg/kg) for general anaesthesia and follow till 24 hours. |
| Intervention |
Group I |
This group will be given general anaesthesia with injection of Fentanyl(2mcg/kg), Propofol(2mg/kg),Atracurium(0.5mg/kg) ; after which sphenopalatine ganglion block under aseptic precaution and ultrasound guidance will be given. 1ml of 0.75% Ropivacaine injected around sphenopalatine ganglion and followed till 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Patient planned for cleft palate repair under general anaesthesia with age group between 6 months to 7 yrs.
ASA 1 , ASA 2, ASA 3 patients |
|
| ExclusionCriteria |
| Details |
Infection over target site.
Bleeding diathesis.
Allergic to local anaesthetic.
High risk patient who require post operative ICU care. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to first rescue analgesia using FLACC score after intervention |
at 1h, 2h, 6h, 12h, 24h. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain assessment using FLACC score |
at 1h,2h,6h,12h,24h. |
| Blood loss using preoperative and postoperative CBC report |
the day before and 24 hours after surgery. |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
24/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/02/2025 |
| 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) |
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
|
Sphenopalatine ganglion block is a procedure used to treat various head and facial pain conditions, including migraines, cluster headaches, and facial neuralgia.Sphenopalatine Ganglion Block in cleft palate surgery suggests it can effectively reduce postoperative pain and opioid consumption, potentially improving recovery outcomes. Studies highlight its role in providing targeted analgesia while minimizing systemic side effects. Additionally, SPG block may contribute to enhanced patient satisfaction and faster postoperative mobilization.
|