| CTRI Number |
CTRI/2024/04/066145 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
18/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pterygopalatine fossa block on postoperative pain relief in Adenotonsillectomy surgeries |
|
Scientific Title of Study
|
Effect of ultrasound guided Pterygopalatine fossa block on postoperative pain relief in paediatric adenotonsillectomy surgeries under general anaesthesia A Randomized controlled 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 |
Dr Akalya K |
| Designation |
Postgraduate student |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Postgraduate student,
Department of Anaesthesiology,
Bangalore Medical College and Research Institute,
Bangalore 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
8508004480 |
| Fax |
|
| Email |
akal127.ks@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhaskara B |
| Designation |
Associate professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Associate professor,
Department of Anaesthesiology,
Bangalore Medical College and Research Institute,
Bangalore 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
9902016020 |
| Fax |
|
| Email |
drbhaskar.md@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akalya K |
| Designation |
Postgraduate student |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Postgraduate student,
Department of Anaesthesiology,
Bangalore Medical College and Research Institute,
Bangalore 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
8508004480 |
| Fax |
|
| Email |
akal127.ks@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore Medical College and Research Institute, Bangalore |
|
|
Primary Sponsor
|
| Name |
Bangalore Medical College and Research Institute |
| Address |
Department of Anaesthesiology
Bangalore Medical College and Research Institute
Bangalore 560002 |
| 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 Akalya K |
Bangalore Medical College and Research Institute |
Department of Anaesthesiology
3rd floor major OT
MPB building
Victoria Hospital
Bangalore 560002
Bangalore
KARNATAKA |
8508004480
akal127.ks@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee of Bangalore Medical College and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bilateral Pterygopalatine fossa block |
In test group, Bilateral Pterygopalatine fossa block will be given after general anaesthesia by ultrasound guided technique and then evaluate the total analgesic requirement in 24 hrs |
| Comparator Agent |
In Comparative (control) group, Pterygopalatine fossa block will not be given |
In Control group, Pterygopalatine fossa block will not be given to the patient after general anaesthesia and assessing the total analgesic requirements in 24 hrs in control group |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 6 to 16 years
2.Patients belongs to ASA grade 1,2
3.Patients posted for elective adenotonsillectomy surgeries who are willing to give informed consent |
|
| ExclusionCriteria |
| Details |
1.Parents/caregivers refusal
2.Patients belongs to ASA grade 3,4
3.Hypersensitivity to Local anaesthetics
4.Any history of developmental delay, bleeding diathesis,mental retardation,upper or lower respiratory tract infections,skin lesions,wounds at the puncture site of block |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the total analgesic requirements in first 24 hrs postoperatively among the patients with and without Pterygopalatine fossa block |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the time for first rescue analgesia, intraoperative haemodynamic changes and incidence of any complications among the patients with and without Pterygopalatine fossa block |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/05/2024 |
| Date of Study Completion (India) |
23/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This study is to assess the effect of Pterygopalatine fossa block by ultrasound guided technique on postoperative analgesic requirements in 24 hours and also assessing intraoperative haemodynamic changes and comparing with the control group patients without the Pterygopalatine fossa block.As systemic analgesics are insufficient to control post adenotonsillectomy pain,regional anaesthetic technique using local anaesthetics are an option and offer advantages over standard approaches.Ultrasound guided suprazygomatic approach to the maxillary nerve in the Pterygopalatine fossa seems to be the safest in children |