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CTRI Number  CTRI/2025/05/086920 [Registered on: 14/05/2025] Trial Registered Prospectively
Last Modified On: 13/05/2025
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   Comparing the effectiveness of three different doses of magnesium sulfate added to bupivacaine using spinal anesthesia in patients with below umbilical surgeries 
Scientific Title of Study   A comparative study of three different doses of magnesium sulphate as adjuvant with injection bupivacaine 0.5 percent heavy for infraumbilical procedures under subarachnoid block 
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 Apeksha Sureshbhai Prajapati  
Designation  MD Anaesthesia 2nd Year 
Affiliation  pdu college civil hospital rajkot 
Address  3rd floor opd building department of anesthesia pdu college civil hospital RAJKOT
3rd floor opd building department of anesthesia pdu college civil hospital RAJKOT
Rajkot
GUJARAT
360001
India 
Phone  7990281091  
Fax    
Email  apexaprajapati8@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Ashutosh Vyas 
Designation  Associate Professor  
Affiliation  pdu college civil hospital rajkot 
Address  Department Of Anaesthesiology, 3rd Floor ,opd building, pdu civil hospital,near hospital chalk,rajkot
Department Of Anaesthesiology, 3rd Floor ,opd building, pdu civil hospital,near hospital chalk,rajkot
Rajkot
GUJARAT
360001
India 
Phone  9898188464  
Fax    
Email  dr.ashutoshvyas@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Dr Apeksha Sureshbhai Prajapati  
Designation  MD Anaesthesia 2nd Year 
Affiliation  pdu college civil hospital rajkot 
Address  3rd floor opd building department of anesthesia pdu college civil hospital RAJKOT
3rd floor opd building department of anesthesia pdu college civil hospital RAJKOT
Rajkot
GUJARAT
360001
India 
Phone  7990281091  
Fax    
Email  apexaprajapati8@gmail.com  
 
Source of Monetary or Material Support  
3rd floor opd building department of anesthesia pdu college civil hospital Rajkot gujarat India pin code-360001  
 
Primary Sponsor  
Name  Dr Apeksha Sureshbhai Prajapati 
Address  3rd floor opd building department of anesthesia pdu college civil hospital rajkot gujarat india pin code-360001 
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 Apeksha sureshbhai Prajapati   pdu college civil hospital rajkot gujarat india  3RD FLOOR ,OPD BUILDING,ANAESTHESIA DEPARTMENT,PDU CIVIL HOSPITAL, NEAR HOSPITAL CHALK
Rajkot
GUJARAT 		 7990281091

apexaprajapati8@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Human) P.D.U. Medical College, Rajkot.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  bupivacaine with MgSO4 (50%)(100mg)  patients undergoing for infraumbilical surgeries in spinal anesthesia using Inj. Bupivacaine Heavy (0.5%) 3ml plus MgSO4 (50%) 0.2 ml [100mg] will be done for 1 year 
Intervention  bupivacaine with MgSO4 (50%)(15mg)  patients undergoing for infraumbilical surgeries in spinal anesthesia using Inj. Bupivacaine Heavy (0.5%) 3ml plus MgSO4 (50%) 0.1 ml [15mg] plus 0.1 ml normal saline will be done for 1 year  
Comparator Agent  bupivacaine with MgSO4 (50%)(75mg)  patients undergoing for infraumbilical surgeries in spinal anesthesia using Inj. Bupivacaine Heavy (0.5%) 3ml plus MgSO4 (50%) 0.15 ml [75mg] plus 0.05 ml normal saline will be done for 1 year 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Patients undergoing subarachnoid block for infraumbilical surgeries
2) Patients aged 18 to 60 years
3) Patients of ASA â… , â…¡ and â…¢ grade  
 
ExclusionCriteria 
Details  1) Patients refusal
2) Uncooperative patients
3) Patients with deformity of spine
4) Patients with coagulation disorder, thrombocytopenia, increased intracranial pressure, severe hypovolemia, severe heart disease, local infection at injection site, allergy to local anaesthetic.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To see the duration and efficacy of magnesium sulphate as an adjuvant to bupivacaine heavy in Subarachnoid block   every 10 min for 120min till recovery for 2 months 
 
Secondary Outcome  
Outcome  TimePoints 
compare & evaluate the efficacy of a magnesium sulphate as an adjuvant in three different doses with inj Bupivacaine 0.5% heavy for spinal anaesthesia in terms of block characteristics haemodynamic parameters safety profile & post operative analgesia.   every 10 min for 120min till recovery for 2 months 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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 4 
Date of First Enrollment (India)   08/06/2025 
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="72"
Months="2"
Days="24" 
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  

Regional Anesthesia in Lower Limb Surgeries:

Regional anesthesia, especially subarachnoid block (SAB), is preferred for lower limb surgeries over general anesthesia due to various benefits, such as:

Ease of administration

Dense sensory, motor, and sympathetic blockade

Better post-operative pain relief

Reduced incidence of postoperative nausea and vomiting (PONV)

Lower cost compared to general anesthesia

Reduced thromboembolism risk

Bupivacaine in SAB:

Bupivacaine is the most commonly used local anesthetic for SAB.

However, it has a limited duration of action, necessitating the use of adjuvants for prolonged effects.

Role of Adjuvants:

The use of adjuvants in SAB is gaining popularity for enhancing blockade duration, improving patient satisfaction, and achieving better surgical outcomes.

Adjuvants also provide prolonged analgesia, optimal resource utilization, and a higher success rate compared to general anesthesia.

Magnesium Sulfate as an Adjuvant:

Magnesium sulfate is an effective adjuvant for prolonging the duration of SAB.

It is a non-competitive antagonist of N-Methyl D-Aspartate (NMDA) receptors, preventing central sensitization from peripheral nociceptive stimulation.

Its antinociceptive properties contribute to prolonged pain relief, especially for postoperative pain management.

Safety of Magnesium Sulfate:

Magnesium sulfate has minimal adverse effects when used in low doses, making it a safe and beneficial addition to SAB for enhancing patient outcomes and reducing pain.

 

 
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