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CTRI Number  CTRI/2026/04/107938 [Registered on: 09/04/2026] Trial Registered Prospectively
Last Modified On: 09/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study to Evaluate the Effect of Adding Magnesium Sulphate to Levobupivacaine in blocking Abdominal Nerve for Better Pain Relief After Inguinal Hernia Surgery. 
Scientific Title of Study   ARandomized Controlled Trial to Evaluate Magnesium Sulphate as an Adjuvant to 0.25 Percent Levobupivacaine in Ultrasound Guided Transversus Abdominis Plane Block for Postoperative Analgesia in Patients Undergoing Unilateral Inguinal Herniorraphy 
Trial Acronym  MAGLEV-TAP Trial 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jayanti Gupta 
Designation  Secondary DNB Resident  
Affiliation  Swami Dayanand Hospital 
Address  Department of Anaesthesia,Swami Dayanand Hospital,Dilshad Garden,East Delhi,India-110095

East
DELHI
110095
India 
Phone  8707251341  
Fax    
Email  jayanti.gupta1994@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aashish Dang 
Designation  Senior Consultant 
Affiliation  Swami Dayanand Hospital 
Address  Flat no.4 New Doctors Flat Hindu Rao Hospital Delhi

East
DELHI
110007
India 
Phone  9810710458  
Fax    
Email  drdangi679@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Aashish Dang 
Designation  Senior Consultant 
Affiliation  Swami Dayanand Hospital 
Address  Flat no.4 New Doctors Flat Hindu Rao Hospital Delhi

East
DELHI
110007
India 
Phone  9810710458  
Fax    
Email  drdangi679@gmail.com  
 
Source of Monetary or Material Support  
Swami Dayanand Hospital,Dilshad Garden,East Delhi-110095,India 
 
Primary Sponsor  
Name  Swami Dayanand Hospital  
Address  Department of Anaesthesia,Swami Dayanand Hospital,Dilshad Garden,East Delhi -110095,India 
Type of Sponsor  Other [[Hospital/Institute]] 
 
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 
DrJayanti Gupta  Swami Dayanand Hospital   Room no. 18,Department of Anaesthesia,Swami Dayanand Hospital,Dilshad Garden,East Delhi -110095,India
East
DELHI 		 8707251341

jayanti.gupta1994@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
HIEC SDNH-Hospital Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Magnesium Sulphate + 0.25% Levobupivacaine  Patients will receive an ultrasound-guided Transversus Abdominis Plane (TAP) block with 20 ml of 0.25% levobupivacaine combined with magnesium sulphate (150 mg) for postoperative analgesia following unilateral inguinal herniorrhaph 
Intervention  Magnesium sulphate with 0.25% Levobupivacaine  Ultrasound-guided TAP block with 0.25% levobupivacaine + magnesium sulphate (dose e.g., 150–250 mg) administered bilaterally for postoperative analgesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients aged between 18-60 years
Patients belonging to American Society Of Anesthesiologist (ASA) physical status grade I – II
Patients undergoing elective unilateral inguinal hernia surgeries under subarachnoid block 
 
ExclusionCriteria 
Details  Patients suffering from defect of spinal cord or any anatomical deformity of spine.
Patients having infections at the site of injection.
Patients with coagulopathy.
Patients with prior back surgery.
Patients with raised intracranial pressure.
•Patients with history of cardiac, respiratory,renal or hepatic diseases.
•Allergy to study medication or local Anaesthetic s.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Duration of postoperative analgesia, defined as the time from administration of ultrasound-guided transversus abdominis plane block to the first request for rescue analgesia, measured in hours during the first 24 hours after surgery.  Up to 24 hours postoperatively. 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess postoperative pain scores using the Numeric Pain Rating Scale (NRS/Pain) at predefined time intervals.
2. To evaluate the time to first request for rescue analgesia
3. To compare the total postoperative analgesic (rescue analgesia) consumption within the first 24 hours after surgery.
4. To monitor and compare any adverse effects or complications related to the TAP block or adjuvants used.
 		 post-operatively for pain scores and hemodynamic parameters; cumulative rescue analgesic consumption and patient satisfaction assessed at 24 hours; adverse effects monitored during the first 24 hours after surgery. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 3 
Date of First Enrollment (India)   25/04/2026 
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   This randomized controlled trial aims to compare the efficacy of 0.25% levobupivacaine alone versus 0.25% levobupivacaine combined with 10% Magnesium Sulphate in ultrasound-guided Transversus Abdominis Plane (TAP) block for postoperative analgesia in patients undergoing unilateral inguinal herniorrhaphy. Patients will be randomly allocated into two groups to receive TAP block with either levobupivacaine alone or levobupivacaine with magnesium sulphate. Post-operative pain scores will be assessed using the Numerical Pain Rating Scale (NRS). The duration of analgesia, time to first rescue analgesic, and total analgesic consumption within the first 24 hours after surgery will be recorded and compared between the groups to evaluate whether the addition of magnesium sulphate improves the quality and duration of postoperative analgesia. 
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