| CTRI Number |
CTRI/2012/12/003244 [Registered on: 20/12/2012] Trial Registered Retrospectively |
| Last Modified On: |
20/12/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of a regional block in eye (Subtenons Block)for prevention of pain and changes in heart rate during squint surgery in children under general anaesthesia- A study |
|
Scientific Title of Study
|
Efficacy of Subtenon’s Block in Paediatric Squint Surgery for Prevention of Perioperative Pain and Intraoperative Oculocardiac Reflex- A Randomized Controlled Trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Ref.No.IEC/NP-21/03.11.09 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rashmi Ramachandran |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room No 5013
Department of Anaesthesia,
All India Institute of Medical Sciences,
Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
9811422188 |
| Fax |
|
| Email |
rashmiramachandran1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rashmi Ramachandran |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room No 5013
Department of Anaesthesia,
All India Institute of Medical Sciences,
Ansari Nagar
DELHI
110029
India |
| Phone |
9811422188 |
| Fax |
|
| Email |
rashmiramachandran1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rashmi Ramachandran |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room No 5013
Department of Anaesthesia,
All India Institute of Medical Sciences,
Ansari Nagar
DELHI
110029
India |
| Phone |
9811422188 |
| Fax |
|
| Email |
rashmiramachandran1@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Ansari Nagar, Delhi, India
110029 |
| 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 |
| Dr Rashmi Ramachandran |
All India Institute of Medical Sciences |
Room No 5013, Teaching Block, Department of Anaesthesia, All India Institute of Medical Sciences,
South
DELHI |
9811422188
rashmiramachandran1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
squint surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fentanyl |
Fentanyl is an opioid analgesic and will be used as a comparator intravenously to prevent pain in the other group. Dose of fentanyl used is 2 mcg/kg as single dose |
| Intervention |
Subtenons Block |
The block is given by the surgeons after general anaesthesia. A single injection is given with 2 ml of bupivacaine |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2 patients posted for elective squint surgery |
|
| ExclusionCriteria |
| Details |
a)Parent refusal
b)hypersensitivity to local anesthetic drugs
c)Any contraindication to subtenon’s block
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Subtenon’s Block in decreasing perioperative pain
|
Intraoperative period, 0.5 hours, 1 hours, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of subtenons block in decreasing perioperative oculocardiac reflex and postoperative nausea and vomiting |
0, 0.5, 1, 2, 6, 12, 24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
17/09/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Regional anaesthesia has been a mainstay in ophthalmic surgeries in adults. However recently many studies have advocated use of regional anaesthetic techniques to supplement analgesia in peadiatric population as well due to its multiples advantages.
The primary aim of the study is to evaluate the efficacy of subtenon’s block in decreasing perioperative pain.
The secondary aims include to evaluate the efficacy of the block in decreasing intraoperative oculocardiac reflex and postoperative nausea and vomiting.
|