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CTRI Number  CTRI/2024/12/078420 [Registered on: 23/12/2024] Trial Registered Prospectively
Last Modified On: 19/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial comparing two combinations of drugs in ultrasound guided transversus abdominis plane block to determine the efficacy for post operative pain relief in patients undergoing Hysterectomy surgery. 
Scientific Title of Study   Comparison of Dexamethasone and Magnesium sulphate as adjuvants to Ropivacaine in ultrasound guided transversus abdominis plane block for post operative analgesia in patients undergoing Total Abdominal Hysterectomy: A Randomized Controlled Trial. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mrunal Bharsakale 
Designation  Junior Resident 
Affiliation  N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital. 
Address  Department of Anaesthesiology, N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Digdoh Hills

Nagpur
MAHARASHTRA
440019
India 
Phone  7798517567  
Fax    
Email  mbharsakale@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anjali Bhure 
Designation  Professor and Head, Department of Anaesthesiology 
Affiliation  N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital. 
Address  Department of Anaesthesiology, N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Digdoh Hills, Nagpur.

Nagpur
MAHARASHTRA
440019
India 
Phone  9822563121  
Fax    
Email  anjali_bhure@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Mrunal Bharsakale 
Designation  Junior Resident 
Affiliation  N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital. 
Address  Department of Anaesthesiology, N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Digdoh Hills, Nagpur.

Nagpur
MAHARASHTRA
440019
India 
Phone  7798517567  
Fax    
Email  anjali_bhure@yahoo.co.in  
 
Source of Monetary or Material Support  
N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Nagpur, Maharashtra, India, 440019 
 
Primary Sponsor  
Name  N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital. 
Address  N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Nagpur, Maharashtra, India, 440019 
Type of Sponsor  Private medical college 
 
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 Mrunal Bharsakale  N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital.  Department of Anaesthesia, N.K.P Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Nagpur, Maharashtra, India, 440019
Nagpur
MAHARASHTRA 
7798517567

mbharsakale@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexamethasone with Ropivacaine  8mg Dexamethasone and 15 ml of 0.20% Ropivacaine on each side for Transversus Abdominis Plane Block 
Comparator Agent  Magnesium Sulphate with Ropivacaine  150mg Magnesium sulphate and 15 ml of 0.20% Ropivacaine on each side for Transversus Abdominis Plane Block 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1) Patients scheduled for elective Total Abdominal Hysterectomy surgery under subarachnoid block.

2) American Society of Anaesthesiologists (ASA) physical status 1 and 2.

3) Patients giving consent for study.

4) BMI less than 30 kg/m3 
 
ExclusionCriteria 
Details  1) Bleeding disorders.
2) History of cardiac, renal, respiratory or hepatic disease.
3) Allergy to study drugs.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare post operative analgesia of Dexamethasone and Magnesium sulphate as an adjuvant to Ropivacaine in ultrasound guided transversus abdominis plane block in Total Abdominal Hysterectomy in terms of

1) Numerical rating scale (NRS) for pain assessment.

2) Time of requirement of first rescue analgesia.

3) Total analgesic doses required in first 24 hours 
1)Post-operative pain assessment will be done by Numerical Rating score (NRS) at 0,1,2,4,6,12 and 24 hours after surgery.

2) Time of requirement of first rescue analgesia.

3) Total analgesic doses required in first 24 hours.

4) Total number of rescue analgesia will be calculated in 24 hours.

0 Hours will be taken as the time of block 
 
Secondary Outcome  
Outcome  TimePoints 
To compare side effects of Dexamethasone and Magnesium sulphate as an adjuvant to Ropivacaine in ultrasound guided transversus abdominis plane block in Total Abdominal Hysterectomy with respect to :

1) Haemodynamic instability

2) Sedation 
1) Haemodynamics will be evaluated by parameters
a) Heart rate.
b)Systolic blood pressure (SBP).
c)Diastolic blood pressure (DBP)
d)Mean blood pressure (MBP).
e)Oxygen saturation (SpO2).
at 0,1,2,4,6,12 and at 24 hrs.

2) Sedation will be evaluated by Ramsay’s Sedation Score at 0,1,2,4,6,12 and at 24 hrs.

0 hours will be taken as the time of block. 
 
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   N/A 
Date of First Enrollment (India)   01/01/2025 
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  

Postoperative analgesia aims to reduce the negative consequences of acute postsurgical pain and help the patient transition smoothly back to normal function. Acute postoperative pain without adequate management leads to persistent postsurgical pain or chronic pain.  Regional anaesthesia provides site specific, effective and long lasting anaesthesia.  Some of the abdominal nerve blocks are transversus abdominis plane, subcostal, rectus, ilioinguinal and iliohypogastric, transversalis fascia plane, and quadratus lumborum block. Transversus abdominis plane block is a peripheral nerve block that blocks sensation to anterior and lateral abdominal wall as well as the parietal peritoneum. The TAP anatomical compartment is located between the internal oblique and transversus abdominis muscles and contains the T6 to L1 thoracolumbar nerves.  The T9 to T11 Intercostal and T12 Subcostal (SC) nerves penetrate the transversus abdominis plane compartment posterior to the midaxillary line. It is one of the most common truncal block for post operative analgesia in lower abdominal surgeries because of its easy accessibility, safety and reliability. Ropivacaine, an enantiomer of Bupivacaine, is a long-acting amide and less likely to penetrate large myelinated motor fibers so it has relatively shown lesser motor blockade with safer cardiac profile used for peripheral nerve block. Addition of adjuvant improves the efficacy of local anaesthetics by reducing the duration of onset of action, prolonging the duration of action, decrease pain intensity and reduce consumption of systemic opioids and lesser systemic side effects. Dexamethasone is a highly potent, long acting glucocorticoid. It acts by inhibiting    potassium conductance by binding to glucocorticoid receptors which decreases  the activity of nociceptive C-fibres and may also prolong the analgesia duration through systemic anti-inflammatory effects and local vasoconstrictive action. Magnesium sulphate is an N-methyl D-aspartate (NMDA) receptor antagonist. It is a non-competitive antagonist which blocks the voltage- dependent ion channels. This receptor is found in many parts of the body, including the nerve endings and plays a role in modulating inflammatory responses and pain responses by preventing central sensitisation caused by peripheral nociceptive stimulation. Hence, the aim of this study is to compare the efficacy of Dexamethasone versus Magnesium sulphate with Ropivacaine in ultrasound guided transversus abdominis plane(TAP) block for patients undergoing Total Abdominal Hysterectomy.

 
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