| CTRI Number |
CTRI/2024/03/063686 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
05/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Studying how two medications, dexamethasone and ketorolac, work with levobupivacaine in a pain-relief technique called transverse abdominis plane block for women undergoing caesarean section |
|
Scientific Title of Study
|
Comparison of dexamethasone vs ketorolac as an adjutant to levobupivacaine in ultrasound guided transverse abdominis plane block for postoperative analgesia in patients undergoing lower segment caesarean section under neuraxial anesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suhas M |
| Designation |
Post graduate |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Department of Anaesthesiology, Saveetha medical college and hospital, Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
7904911583 |
| Fax |
|
| Email |
drsuhasm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rathna |
| Designation |
Professor |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Department of Anaesthesiology, Saveetha medical college and hospital, Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
9940475385 |
| Fax |
|
| Email |
drrathna86@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rathna |
| Designation |
Professor |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Department of Anaesthesiology, Saveetha medical college and hospital, Chennai
TAMIL NADU
602105
India |
| Phone |
9940475385 |
| Fax |
|
| Email |
drrathna86@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Saveetha medical college and hospital, Thandalam, Chennai |
|
|
Primary Sponsor
|
| Name |
Saveetha medical college and hospital |
| Address |
Department of anaesthesiology, Saveetha medical college and hospital, Thandalam |
| 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 Suhas M |
Saveetha medical college and hospital |
Operation theatre complex, Department of anaesthesiology, Saveetha nagar
Chennai
TAMIL NADU |
7904911583
drsuhasm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha medical college and hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Ultrasound guided transverse abdominis plane block |
Single shot injection using 0.25% levobupivacaine + 15mg Ketorolac |
| Intervention |
Ultrasound guided transverse abdominis plane block |
Single shot injection using 0.25% levobupivacaine + 4mg dexamethasone |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
American Society of Anaesthesiologists (ASA)
physical status I and II, patients undergoing lower segment caesarean section, Patient’s willingness to participate in study |
|
| ExclusionCriteria |
| Details |
Patient’s refusal, BMI more than 35, Allergy to opioids, amide group of local anaesthetics and non steroidal anti-inflammatory drugs, Coagulation derangement or bleeding disorder, Infection at the site of block, Patients with cardiovascular pulmonary or
neurological diseases, Patients converted to general anaesthesia after giving subarachnoid block, Uncontrolled intraoperative bleeding. |
|
|
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 |
| Compare the analgesic efficacy of dexamethasone vs ketorolac as an adjutant to levobupivacaine in ultrasound guided transverse abdominis plane block for postoperative analgesia in patients undergoing lower segment caesarean section surgery |
Post operative VAS score in 2,4,6,12 and 24 hours.
Duration of onset of pain in Hours
Duration of onset of motor power in Hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative hemodynamics , patient satisfaction score, VAS score |
Post operative Blood pressure and Heart rate at 2,4,6,12 and 24 hours.
Patient satisfaction score after 24 hours. |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
19/03/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this study, we would like to compare the analgesic efficacy of dexamethasone and ketorolac as an adjutant to levobupivacaine in ultrasound guided transverse abdominis plane block for postoperative analgesia in patients undergoing lower segment caesarean section under neuraxial anesthesia.
Intraoperatively, BP and PR measured at 0, 5, 10, 15 and 30 mins. Post operatively PR and BP measured at every 20 mins for first 2 hours and at 4,6,12 and 24 hours. Post operative VAS score in 2,4, 6,12 and 24 hours. Patient satis Score measured after 24 hours. Duration of onset of pain and motor power in hours.
Thank you |