| CTRI Number |
CTRI/2017/10/010307 [Registered on: 31/10/2017] Trial Registered Retrospectively |
| Last Modified On: |
29/10/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Only Paracetamol Drug AND Drug With Nerve Block Comparisions |
|
Scientific Title of Study
|
Comparision of the Effects of Intercostal Block With Ropivacaine Added to Half Dose of Intravenous Paracetamol Infusion With Full Dose Intravenous Paracetamol Infusion Alone for Pain control after 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 |
DEBARATI GOSWAMI |
| Designation |
SENIOR RESIDENT |
| Affiliation |
BANKURA SAMMILANI MEDICAL COLLEGE |
| Address |
B.S.Medical College,GOBINDANAGAR,BANKURA 722102
B.S.Medical College,GOBINDANAGAR,BANKURA 722102
Bankura
WEST BENGAL
722102
India |
| Phone |
9434659470 |
| Fax |
|
| Email |
debarati.goswami92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DEBARATI GOSWAMI |
| Designation |
SENIOR RESIDENT |
| Affiliation |
BANKURA SAMMILANI MEDICAL COLLEGE |
| Address |
B.S.Medical College,GOBINDANAGAR,BANKURA 722102
B.S.Medical College,GOBINDANAGAR,BANKURA 722102
Bankura
WEST BENGAL
722102
India |
| Phone |
9434659470 |
| Fax |
|
| Email |
debarati.goswami92@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DEBARATI GOSWAMI |
| Designation |
SENIOR RESIDENT |
| Affiliation |
BANKURA SAMMILANI MEDICAL COLLEGE |
| Address |
B.S.Medical College,GOBINDANAGAR,BANKURA
B.S.Medical College,GOBINDANAGAR,BANKURA 722102
Bankura
WEST BENGAL
722102
India |
| Phone |
9434659470 |
| Fax |
|
| Email |
debarati.goswami92@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
STATE GOVERMENT |
| Address |
B.S.M.C,BANKURA,WEST BENGAL,INDIA |
| 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 |
| DEBARATI GOSWAMI |
Bankura Sammilani Medical College |
Surgery Operation Theatre,B.S.M.C,BANKURA
Bankura
WEST BENGAL |
9434659470
debarati.goswami92@gmail.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 |
CHOLECYSTITIS, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intercostal Block |
IV Paracetamol Alone And Half Dose Paracetamol With Intercostal Block With Ropivacaine.Intercostal Block in 6th to 10th Intercostal Places. |
| Comparator Agent |
Paracetamol vs Half Paracetamol plus Intercostal Block |
Full Dose IV Paracetamol with Half Dose IV Paracetamol and Intercostal Block With Ropivacaine |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
ASA I AND II,Posted for Open Cholecystectomy |
|
| ExclusionCriteria |
| Details |
Patient Refusal,Seizure History,Pregnant,Liver or Renal Failure,Psychiatric Diseases. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| DURATION OF ANALGESIA |
Upto VAS score 40 or above |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ADVERSE EFFECTS |
upto VAS score 40 or above |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="140" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2016 |
| Date of Study Completion (India) |
31/10/2016 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Purpose-Analgesia which is better in patients with open cholecystectomyBackground-Many analgesics tried,compared in these cases,intercostal block also often given.But there isno definite study regarding the block. This Study Shows that adding Intercostal block to IV Paracetamol gives better Analgesia to Patients with Open Cholecystectomy. |