| CTRI Number |
CTRI/2016/06/007039 [Registered on: 24/06/2016] Trial Registered Retrospectively |
| Last Modified On: |
21/06/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative study of two different local anaesthetic drugs given epidurally for relieving postoperative pain after major abdominal cancer surgery. |
|
Scientific Title of Study
|
A Comparative Study of ropivacaine with fentanyl and bupivacaine with fentanyl for postoperative epidural analgesia after major abdominal oncosurgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anita Kulkarni |
| Designation |
Senior Consultant Anaesthesia |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Centre |
| Address |
Department Of Anaesthesia
Rajiv Gandhi Cancer Institute and Research Centre
Rohini;Delhi
North West
DELHI
110085
India |
| Phone |
9891064785 |
| Fax |
|
| Email |
anitackulkarni@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shagun Bhatia Shah |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Centre |
| Address |
H.No-174-175;Ground Floor
Pocket-17;Sector-24;Rohini
North West
DELHI
110085
India |
| Phone |
9891769779 |
| Fax |
9891769779 |
| Email |
drshagun_2010@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shagun Bhatia Shah |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Centre |
| Address |
H.No-174-175;Ground Floor
Pocket-17;Sector-24;Rohini
H.No-174-175;Ground Floor
Pocket-17;Sector-24;Rohini
North West
DELHI
110085
India |
| Phone |
09891769779 |
| Fax |
|
| Email |
drshagun_2010@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi Cancer Institute and Research Centre; Sector-5;Rohini;Delhi-110085 |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi Cancer Institute and Research Centre |
| Address |
Rajiv Gandhi Cancer Institute and Research Centre
Sector-5 Rohini Delhi-110085 |
| 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 Anita Kulkarni |
Rajiv Gandhi Cancer Institute and Research Centre |
Major Operation Theatre;Third Floor;Department ofAnaesthesia; Sector-5 Rohini; Delhi-110085
North West
DELHI |
9891064785
anitackulkarni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board of Rajiv Gandhi Cancer Institute and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients Undergoing Major Abdominal Oncosurgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bupivacaine |
Epidural 0.1%Bupivacaine with Fentanyl(2 microgram/ml)postoperatively |
| Intervention |
Ropivacaine |
Epidural 0.1% Ropivacaine with Fentanyl (2microgram/ml)Postoperatively |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Weight between 45-75 Kg
ASA Physical Status I, II and III
Elective major oncosurgery via a vertical, midline infraumbilical incision |
|
| ExclusionCriteria |
| Details |
Patient refusal for Regional Anaesthesia
Contraindications for Regional Anaesthesia(coagulopathy,regional infection)
History of allergic reaction to Bupivacaine, Ropivacaine or Fentanyl
Spinal deformity |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS score for postoperative pain |
10mins,1hour,6hour,12hour,18 hour and 24 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Bromage Score for motor blockade |
10 mins,1hour,6 hours,12 hours,18 hours and 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 |
|
Date of First Enrollment (India)
|
25/03/2015 |
| 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="0"
Months="6"
Days="0" |
|
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
|
This is a prospective, randomized, double blind ,parallel group, active controlled, single centric interventional trial comparing the analgesic efficacy of epidural ropivacaine with fentanyl and bupivacaine with fentanyl after major abdominal oncosurgery at fixed time points in 60 patients of either sex at Rajiv Gandhi Cancer Institute and Research Centre.VAS Sore for postoperative pain relief is the primary outcome measure and Bromage Score for motor blockade is the secondary outcome measure at various time points of 10 minutes, 1hour, 6 hours, 12 hours, 18 hours and 24 hours postoperatively |