CTRI Number |
CTRI/2017/08/009340 [Registered on: 10/08/2017] Trial Registered Retrospectively |
Last Modified On: |
09/08/2017 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Follow Up Study |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
To study pain relieving effect of two medicine ropivacaine and dexamethasone after gall bladder removal. |
Scientific Title of Study
|
A study to compare postoperative analgesic efficacy of ropivacaine alone or in combination with dexamethasone for TAP Block in open cholecystectomy |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr SHASI KIRAN |
Designation |
SENIOR PROFESSOR |
Affiliation |
Deptt of Anaesthesia and critical care,PGIMS ROHTAK |
Address |
Deptt. of Anaesthesia and critical care,Pt.B.D.SHARMA PGIMS ROHTAK Deptt. of anaesthesia and critical care,Pt.B.D. SHARMA PGIMS ROHTAK Rohtak HARYANA 124001 India |
Phone |
9416763899 |
Fax |
|
Email |
drshashi64@rediff.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr ARUNA |
Designation |
JUNIOR RESIDENT |
Affiliation |
Deptt of Anaesthesia and critical care,PGIMS ROHTAK |
Address |
Deptt. of anaesthesia and critical care,Pt. B.D.SHARMA PGIMS ROHTAK Deptt. of anaesthesia and critical care,Pt.B.D.SHARMA PGIMS ROHTAK Rohtak HARYANA 124001 India |
Phone |
9729218522 |
Fax |
|
Email |
yadavaruna771@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr ARUNA |
Designation |
JUNIOR RESIDENT |
Affiliation |
Deptt of anesthesia and critical care,PGIMS ROHTAK |
Address |
Deptt. of Anaesthesia and critical care,Pt. B.D.Sharma,PGIMS Rhotak Deptt. of Anaesthesia and critical care,Pt.B.D.SHARMA PGIMS ROHTAK Rohtak HARYANA 124001 India |
Phone |
9729218522 |
Fax |
|
Email |
yadavaruna771@gmail.com |
|
Source of Monetary or Material Support
|
Pt B.D.Sharma PGIMS, RHOTAK |
|
Primary Sponsor
|
Name |
Pt BDSharma PGIMS ROHTAK |
Address |
PGIMS ROHTAK |
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 SHASHI KIRAN |
PGIMS ROHTAK |
Pt.B.D.SHARMA PGIMS ROHTAK Rohtak HARYANA |
9416763899
drshashi64@rediff.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
HEALTHY, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
nil |
nil |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
ASA Grade 1-3 |
|
ExclusionCriteria |
Details |
1.Contraindication to regional anaesthesia
2.History of local anaesthetic allergy
3.Psychiatric disorder
4.BMI>35kg/sq.m
5.Diabetes Mellitus
6.Chronic opioid use
7.Patient refusal |
|
Method of Generating Random Sequence
|
Random Number Table |
Method of Concealment
|
Pre-numbered or coded identical Containers |
Blinding/Masking
|
Double Blind Double Dummy |
Primary Outcome
|
Outcome |
TimePoints |
twenty four hours Tramadol consumption |
postoperative twenty four hours |
|
Secondary Outcome
|
Outcome |
TimePoints |
Time to first request for analgesic, VAS Score,Nausea Score, Sedation Score, Any side effect |
24 Hours |
|
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 2 |
Date of First Enrollment (India)
|
13/01/2016 |
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="2" Months="6" Days="15" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
This study is a randomized, double blind, parallel group, trail comparing the postoperative analgesic efficacy of 18ml of 0.75% ropivacaine with 2ml of normal saline with 18 ml of o.75% ropivacaine with 2 ml of dexamethasone for TAP block in open cholecystectomy over 60 patients of ASA grade 1-3. The primary outcome will be 24 hr tramadol cosumption. The secondary outcome will be measure include VAS score, nausea score, sedation score and any side effect. |