| CTRI Number |
CTRI/2018/01/011579 [Registered on: 29/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
27/11/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparing pain relief between 2 different eye injections in pediatric eye tumour surgeries |
|
Scientific Title of Study
|
Comparison of peribulbar block and sub-tenon infiltration in paediatric enucleation of the eye |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dilip R Shende |
| Designation |
professor |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
Room no 5011, teaching block , department of anaesthesiology pain medicine and critical care , AIIMS , New delhi
South
DELHI
110029
India |
| Phone |
8800377697 |
| Fax |
|
| Email |
dilipshende@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dilip R Shende |
| Designation |
professor |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
Room no 5011, teaching block , department of anaesthesiology pain medicine and critical care , AIIMS , New delhi
DELHI
110029
India |
| Phone |
8800377697 |
| Fax |
|
| Email |
dilipshende@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dilip R Shende |
| Designation |
professor |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
Room no 5011, teaching block , department of anaesthesiology pain medicine and critical care , AIIMS , New delhi
DELHI
110029
India |
| Phone |
8800377697 |
| Fax |
|
| Email |
dilipshende@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences ,Dr Rajendra prasad centre for ophthalmic sciences, Ansari nagar , New Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS HOSPITAL |
| Address |
Department of Anaesthesiology and Intensive Care and Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi-110 029, India. |
| 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 |
| Dilip R Shende |
AIIMS hospital , Dr Rajendra prasad centre for ophthalmic sciences |
Room no.: 5011, 5th Floor, Teaching Block, Department of Anaesthesiology, Pain Medicine & Critical Care
All India Institute of Medical Sciences, New Delhi-110029
South
DELHI |
8800377697
8800377697
dilipshende@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute Of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
stable patients with ocular tumour, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intravenous fentanyl |
0.5mcg/kg of fentanyl. |
| Intervention |
peribulbar block and subtenon infiltration |
0.3ml/kg of a 1:1 mixture of 0.5%Bupivacaine and 2% lignocaine with 5mcg/ml hyalase . |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Age ranging from 6months to 6 years
ASA Grade I and II
|
|
| ExclusionCriteria |
| Details |
Children whose parents are unwilling to give consent.
ASA Grade III and IV
Children who are mentally retarded or deaf.
Children with a history of allergy to local anaesthetics.
Significant cardiac, respiratory, hepatic or renal dysfunction.
Children with any other intraocular pathology like endophthalmitis or inflammatory diseases
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Perioperative analgesia following enucleation surgeries in children |
All children were assessed immediately after surgery then after 1hr, 2hr,3hr,4hr,8hr and 24 hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Recovery profile :Time to discharge from PACU (post anesthesia care unit)
Incidence of Side effects : PONV and OCR
|
In the postoperative period, all children were assessed immediately then after 1hr, 2hr,3hr,4hr,8hr and 24 hr |
|
|
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 4 |
|
Date of First Enrollment (India)
|
11/01/2016 |
| Date of Study Completion (India) |
17/01/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
 Enucleation is associated with severe pain in the postoperative period. This pain is commonly treated with opioids and NSAIDS. Sub-tenon & peri-bulbar blocks have been found to be effective analgesic for various ophthalmic surgeries. There is no previous report of use of these blocks for perioperative analgesia in enucleation surgeries.  Hence we planned this prospective ,controlled clinical trial
|