| CTRI Number |
CTRI/2024/06/069232 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
12/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the pain relieving efficacy postoperatively of preoperative infiltration of only Ropivacaine vs Ropivacaine plus dexmedetomidine injected in peritonsillar pillars in patients undergoing tonsillectomy. |
|
Scientific Title of Study
|
Comparison of preoperative peritonsillar infiltration of Ropivacaine vs Ropivacaine plus Dexmedetomidine on postoperative analgesia following tonsillectomy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amala Kale |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Dr. D.Y Patil Medical College, Hospital and Research Centre, Pimpri, Pune Research Centre |
| Address |
Department of anesthesia,5th floor,High tech building,Dr.D.Y Patil Medical College, Hospital and Research Centre,Sant Tukaram Nagar Pimpri,Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
415110
India |
| Phone |
7745086838 |
| Fax |
|
| Email |
amalakale9198@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aparna Bagle |
| Designation |
Professor Department of Anesthesia |
| Affiliation |
Dr. D.Y. Patil Medical College, Hospital and Research Centre, Pimpri, Pune |
| Address |
Department of anesthesia, 5th floor, High tech building,Dr.D.Y Patil Medical College Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
415110
India |
| Phone |
9834430811 |
| Fax |
|
| Email |
draparnabagle@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aparna Bagle |
| Designation |
Professor Department of Anesthesia |
| Affiliation |
Dr.D.Y Patil Medical College ,Hospital and Research Centre, Pimpri, Pune |
| Address |
Department of anesthesia, 5th floor, High tech building,Dr.D.Y Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
MAHARASHTRA
411018
Pune
MAHARASHTRA
415110
India |
| Phone |
9834430811 |
| Fax |
|
| Email |
draparnabagle@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central pharmacy,5th floor, High tech building,Dr.D.Y Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri , Pune , Maharashtra , India, Pincode 411018 |
|
|
Primary Sponsor
|
| Name |
Amala Kale |
| Address |
Department of Anesthesia, 5th floor,High tech building,Dr.D.Y Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune |
| Type of Sponsor |
Other [[Self]] |
|
|
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 |
| DrAmala Kale |
Dr.D.Y Patil Medical College and Research Centre |
Department of anesthesia, 5th floor, High tech building,Dr.D.Y Patil Medical College, Hospital and Research Centre , Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA |
7745086838
amalakale9198@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub-Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R590||Localized enlarged lymph nodes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine |
Ropivacaine 0.5% 6 cc plus Dexmedetomidine 1 mcg/kg infiltration in anterior and posterior pillars preoperatively and assessment of postoperative analgesia for 24 hours |
| Intervention |
Ropivacaine |
Ropivacaine 0.5% 6 cc in anterior and posterior tonsillar pillars infiltration preoperatively and assessment of postoperative analgesia for 24 hours |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1)ASA grade 1 and 2 fit patients
2)Ages between 5 and 18 years f either gender
3) Patients posted for elective tonsillectomy under GA
4) Availability of informed consent |
|
| ExclusionCriteria |
| Details |
1)Patients with bleeding and coagulation disorders, hepatic and renal diseases, airway problems, patients with cognitive and developmental problems, patients with neurological and physiological disorders.
2) Patients with known hypersensitivity to the used local anaesthetic.
3) Patients who refused to participate in this study.
4)Signs of acute pharyngeal infection
5)Peritonsillar abscess
6)Use of regular anaesthetic medication
7) Patients below 5 years and above 18 years of age
8)ASA grade 3 and above |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare postoperative analgesia after infiltration of Ropivacaine vs Ropivacaine plus Dexmedetomidine preoperatively in anterior and posterior tonsillar pillars |
After infiltration of the drug,both groups will be compared for analgesic efficacy immediately postoperatively at 1 hr,2 hr,4 hr,8 hr,12 hr,24 hr. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the analgesic efficacy of preoperative pillar infiltration of Dexmedetomidine in addition to Ropivacaine in tonsillectomy patients |
To compare the time for first rescue analgesia, analgesic requirement in 24 hours,side effects like sedation,PONV, time of start of oral intake |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
This is a prospective randomised double blind comparative study to compare preoperative infiltration of Ropivacaine vs Ropivacaine plus dexmedetomidine on postoperative analgesia following tonsillectomy in sample size of 60 patients in the age group 5-18yrs with ASA 1 and 2 fitness. Parameters compared are pain scores postoperatively,time of rescue analgesia, side-effects like nausea, vomiting |