| CTRI Number |
CTRI/2024/08/073009 [Registered on: 28/08/2024] Trial Registered Prospectively |
| Last Modified On: |
23/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
TAP BLOCK for postoperative analgesia for LSCS patients |
|
Scientific Title of Study
|
Comparative analysis of duration of post-operative analgesia between inj ropivacaine 0.375% with inj. Nalbuphine 1.5mg versus inj. Ropivacaine 0.375 % with 1g mgso4 using usg guided tap block in patients undergoing lscs a prospective randomised study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prem kumar R |
| Designation |
junior resident |
| Affiliation |
rajarejeswari medical college |
| Address |
Department of anesthesia 2nd floor Rajarajeswari medical college
Mysore road Kambipura Bangalore Department of anesthesia 2nd floor Rajarajeswari medical college
Mysore road Kambipura Bangalore Bangalore KARNATAKA 560074 India |
| Phone |
8618601268 |
| Fax |
|
| Email |
merpprem.pk@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR SUDHEER |
| Designation |
PROFESSOR |
| Affiliation |
rajarejeswari medical college |
| Address |
Department of anesthesia 2nd floor Rajarajeswari medical college
Mysore road Kambipura Bangalore Department of anesthesia 2nd floor Rajarajeswari medical college
Mysore road Kambipura Bangalore Bangalore KARNATAKA 560074 India |
| Phone |
9741117754 |
| Fax |
|
| Email |
sudheerramegowda81@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR SUDHEER |
| Designation |
PROFESSOR |
| Affiliation |
rajarejeswari medical college |
| Address |
Department of anesthesia 2nd floor Rajarajeswari medical college
Mysore road Kambipura Bangalore Department of anesthesia 2nd floor Rajarajeswari medical college
Mysore road Kambipura Bangalore Bangalore KARNATAKA 560074 India |
| Phone |
9741117754 |
| Fax |
|
| Email |
sudheerramegowda81@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaethesiology Rajarajeswari Medical college and Hospital Bangalore 560074 |
|
|
Primary Sponsor
|
| Name |
Dr Prem Kumar R |
| Address |
Department of Anaethesiology Rajarajeswari Medical college and Hospital Bangalore 560074 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Prem Kumar R |
Rajarajeswari Medical college and Hospital |
Department of Anaethesiology, 2nd Floor, Rajarajeswari Medical college and Hospital, Bangalore 560074 Bangalore KARNATAKA |
8618601268 08028437393 merpprem.pk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Rajarajeswari medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
TRANSVERSE ABDOMINIS PLANE BLOCK in patients undergoing LSCS for post op analgesia |
Patients undergoing LSCS will be divided into Group B Group B patients that underwent transverse abdominis plane block will receive 20 ml of 0.375% of inj. Ropivacaine with 1g of inj. mgso4 bilaterally making total volume of 40ml. |
| Intervention |
TRANSVERSE ABDOMINIS PLANE BLOCK in patients undergoing LSCS for post op analgesia |
Patients undergoing LSCS will be divided into Group A.Group A patients that underwent transverse abdominis plane block will receive 20 ml of 0.375% of inj. Ropivacaine with 1.5mg of inj. nalbuphine bilaterally making total volume of 40ml. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
ASA I to II Female patients.
Aged between 19 to 40 years.
Normal liver and renal function test, Coagulation profile.
Undergoing lower segment cesarean section surgery.
|
|
| ExclusionCriteria |
| Details |
Patients having allergy to LOCAL ANAESTHETICS AND MAGNESIUM SULPHATE.
Patient with history of mental disorder.
Patient refusal.
Infection at the site of procedure.
Morbid Obesity. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Duration of Postop analgesia
2.Rescue analgesia |
0,1,2,4,6,8,10,12,24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hemodynamic parameter like NIBP,HR and SPO2 for 24 hours post operatively
time for first resuce analgesia
Post operative Visual analogue scale Pain score |
First 24 hours monitoring |
|
|
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)
|
10/09/2024 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Postâ€operative analgesia is important after surgery to avoid various complications such as venous thromboembolism, respiratory complications and prolonged hospital stay.The transverses abdominis plane (TAP) block blocks T6–L1 nerve branches and is increasingly playing a role in postoperative analgesia for lower abdominal surgeries. It decreases opioid consumption with the benefits of reducing opioid side effects specially nausea and vomiting. Also earlier ambulation and less hospital admission. Various trials have demonstrated the efficacy of transversus abdominis plane (TAP) block as a component of multimodal postoperative analgesia after cesarean section and lower abdominal surgeries. The block, first described by Rafi in 2001,is a simple and safe technique for analgesia after cesarean section, whether guided by anatomic landmarks or by ultrasound. TAP block in cesarean section is carried out by local anesthetics such as bupivacaine or ropivacaine with a limited duration of action1. Ropivacine: It is a long acting anaesthetic drug belonging to amide group of local anaesthtic. Ropivacine have a greater degree of motor sensory differentiation which could be usefull when motor blockade is undersirable. The reduced lipophilicity is also associated with decreased potential for central nervous toxicity and cardiotoxcity. It is metabolized extensively in the liver and excreted in urine(2) In our study an effort has been made to compare duration post operative analgesia between Ropivacaine with Nalbuphine versus Ropivacaine with Magnesium Sulphate in patients undergoing lower segmental cesarean section. |