| CTRI Number |
CTRI/2023/05/052407 [Registered on: 09/05/2023] Trial Registered Prospectively |
| Last Modified On: |
03/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of combination of bupivacaine- dexamethasone against bupivacaine in TAP block in caesarean section patients for post operative pain. |
|
Scientific Title of Study
|
To Compare Bupivacaine vs Bupivacaine-Dexamethasone in LSCS patients with Transverse abdominis
plane block. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR P KISHORE BABU |
| Designation |
POST GRADUATE |
| Affiliation |
DR D Y PATIL MEDICAL COLLEGE KOLHAPUR |
| Address |
DEPARTMENT OF ANAESTHESIA , 1ST FLOOR , DR. D Y PATIL MEDICAL COLLEGE HOSPITAL KOLHAPUR
Kolhapur
MAHARASHTRA
416003
India |
| Phone |
9700166921 |
| Fax |
|
| Email |
kishorebabu008@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR P KISHORE BABU |
| Designation |
POST GRADUATE |
| Affiliation |
D Y PATIL MEDICAL COLLEGE KOLHAPUR |
| Address |
DEPARTMENT OF ANAESTHESIA , 1 ST FLOOR , DR. D Y PATIL MEDICAL COLLEGE HOSPITAL KOLHAPUR
Kolhapur
MAHARASHTRA
416003
India |
| Phone |
9700166921 |
| Fax |
|
| Email |
kishorebabu008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHEETAL DESAI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
DR D Y PATIL MEDICAL COLLEGE KOLHAPUR |
| Address |
DEPARTMENT OF ANAESTHESIA , 1ST FLOOR , DR. D Y PATIL MEDICAL COLLEGE HOSPITAL KOLHAPUR
Kolhapur
MAHARASHTRA
416003
India |
| Phone |
9822049527 |
| Fax |
|
| Email |
klpskdesai@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR D Y PATIL MEDICAL COLLEGE HOSPITAL , KOLHAPUR |
|
|
Primary Sponsor
|
| Name |
DR D Y PATIL MEDICAL COLLEGE HOSPITAL KOLHAPUR |
| Address |
KADAM WADI KOLHAPUR |
| 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 |
| P KISHORE BABU |
D Y PATIL MEDICAL COLLEGE HOSPITAL |
1ST FLOOR , DEPT OF ANAESTHESIOLOGY , DR D Y PATIL COLLEGE HOSPITAL KOLHAPUR
Kolhapur
MAHARASHTRA |
9700166921
kishorebabu008@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE , D. Y. PATIL MEDICAL COLLEGE , KOLHAPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
TAP BLOCK |
TAP BLOCK IN GROUP A WITH INJ BUPIVACAINE 0.25% 15ML+ INJ DEXAMETHASONE(4mg) AND MONITORED FOR PAIN 24 HRS AFTER THE BLOCK. |
| Comparator Agent |
TAP BLOCK WITH INJ BUPIVACAINE |
TAP BLOCK is given with inj. Bupivacaine 0.25% PLAIN 15ml and monitored for pain for 24 hrs after the block. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
ALL LSCS PATIENTS UNDER SUBARACHNOID BLOCK |
|
| ExclusionCriteria |
| Details |
1) PATIENT REFUSAL
2) PATIENT WITH ASA GRADE III AND IV
3) LOCAL SKIN INFECTIONS( LATERAL ABDOMINAL WALL)
4) SIGNIFICANT CARDIAC DISEASE
5) SUSPECTED COAGULOPATHIES OR BLEEDING DISORDERS
6) ALLERGY TO LOCAL ANAESTHETICS AND STUDY DRUG |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS SCORE will be assessed for the patients |
It will be assessed at a 4hour interval upto 24 hours after giving the block. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| when the BREAKTHROUGH ANALGESIA is to be given for the patients. |
until 24 hours after giving TAP block. |
|
|
Target Sample Size
|
Total Sample Size="176"
Sample Size from India="176"
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
|
N/A |
|
Date of First Enrollment (India)
|
23/05/2023 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
THIS STUDY IS AN RANDOMISED DOUBLE BLIND ACTIVE CONTROLLED STUDY . WE ARE ASSESSING THE POST OPERATIVE ANALGESIC EFFECT AFTER GIVING TAP BLOCK WITH 2 DIFFERENT TYPE OF DRUGS FOR 2 DIFFERENT GROUP OF PATIENTS. FIRST GROUP IS GIVEN TAP BLOCK WITH INJ BUPIVACAINE 0.25 % + INJ DEXAMETHASONE AND SECOND GROUP IS GIVEN TAP BLOCK WITH INJ BPIVACAINE 0.25% PLAIN. POST OPERATIVELY BLOCK WAS GIVEN AND PAIN WAS ASSESSED USING VAS SCORE FOR 24 HOURS. |