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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 
 
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  

Post‐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.

 
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