| CTRI Number |
CTRI/2018/10/016131 [Registered on: 24/10/2018] Trial Registered Retrospectively |
| Last Modified On: |
23/10/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare pain relieving effect of dexamethasone or tramadol with ropivacaine for gall bladder removal surgery. |
|
Scientific Title of Study
|
A study to compare postoperative analgesic efficacy of dexamethasone versus tramadol with ropivacaine for transversus abdominis plane 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 SHASHI KIRAN |
| Designation |
SENIOR PROFESSOR |
| Affiliation |
PGIMS ROHTAK |
| Address |
Department of Anaesthesiology, PGIMS Rhotak
Rohtak
HARYANA
124001
India |
| Phone |
9416763899 |
| Fax |
|
| Email |
drshashi64@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr kuldeep |
| Designation |
junior resident |
| Affiliation |
PGIMS ROHTAK |
| Address |
Department of Anaesthesia, PGIMS, Rhotak
Rohtak
HARYANA
124001
India |
| Phone |
|
| Fax |
|
| Email |
dr.kuldeepkumar76@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr kuldeep |
| Designation |
junior resident |
| Affiliation |
PGIMS ROHTAK |
| Address |
Department of Anaesthesia, PGIMS, Rhotak
Rohtak
HARYANA
124001
India |
| Phone |
|
| Fax |
|
| Email |
dr.kuldeepkumar76@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMS Rhotak |
| Address |
Pt. B.D.Sharma PGIMS Rhotak |
| 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@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Pt. B.D.Sharma Post graduate Institute of medical sciences UHS Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K808||Other cholelithiasis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I-III |
|
| ExclusionCriteria |
| Details |
-contraindication to regional anaesthesia
-history of local anaesthetic allergy
-psychiatric disorder
-chronic opioid use
-BMI > 35 kg/m2
-who refuse to participate in study |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| total tramadol requirement in 24 hours |
total tramadol requirement in 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
VASscore at rest and at knee flexion
sedation score
nausea score |
0 - 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/ Phase 3 |
|
Date of First Enrollment (India)
|
31/03/2017 |
| 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="7"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A stution was recorded and compardedy to compare the analgesic efficacy of tramadol and dexamethasone with ropivacaine for TAP block in open cholecystectomy. 24 hours tramadol compared in both groups. |