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CTRI Number  CTRI/2019/04/018833 [Registered on: 30/04/2019] Trial Registered Prospectively
Last Modified On: 27/02/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of Bupivacaine plus magnesium sulphate with Ropivacaine plus magnesium sulphate local infiltration of wound for most op analgesia 
Scientific Title of Study   Comparison of Bupivacaine plus Magnesium Sulfate with Ropivacaine plus Magnesium Sulphate for wound infiltration for postoperative analgesia in patients undergoing upper abdominal surgery: A Randomized Double Blind study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SVIEC/ON/MEDI/RP/19006  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR Anuja Agrawal 
Designation  Assistant Professor 
Affiliation  Sumandeep Vidyapeeth 
Address  Department of Anaesthesiology Dhiraj Hospital

Vadodara
GUJARAT
391760
India 
Phone    
Fax    
Email  anujagyl@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR Anuja Agrawal 
Designation  Assistant Professor 
Affiliation  SBKSMIRC 
Address  Department of Anaesthesiology Dhiraj Hospital


GUJARAT
391760
India 
Phone    
Fax    
Email  anujagyl@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR Anuja Agrawal 
Designation  Assistant Professor 
Affiliation  SBKSMIRC 
Address  Department of Anaesthesiology Dhiraj Hospital


GUJARAT
391760
India 
Phone    
Fax    
Email  anujagyl@gmail.com  
 
Source of Monetary or Material Support  
DR Anuja Agrawal Department of Anaesthesia, Dhiraj Hospital Sumandeep Vidyapeeth Vadodara Gujarat 391760 
 
Primary Sponsor  
Name  Dr Anuja Agrawal 
Address  Department of Anaesthesiology Dhiraj Hospital SBKSMIRC Vadodara 
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 Anuja Agrawal  Dhiraj Hospital  Deparment of Anaesthesia SBKSMIRC Vadodara
Vadodara
GUJARAT 
9687798989

anujagyl@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Local Infiltration  INJ Bupivacaine 0.5 % 50 mg plus INJ MAgnesium Sulphate 500 mg Diluted with Normal Saline to make total volume of 20 ml 
Comparator Agent  Local Infiltration  INJ Ropivacaine 0.5% 50 mg plus INJ MAgnesium Sulphate 500 mg Dilute with Normal Saline to mAke total Volume of 20 ml 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age >18 years <60 years
ASA-I, II and III
Patient willing to sign informed consent.
Mallampatti class I and II
Upper abdominal surgeries eg. Open Cholecystectomy, Laprotomies, upper abdominal wall mass, etc.
 
 
ExclusionCriteria 
Details  Patient’s refusal.
ASA IV
Mallampatti class III and IV
Known allergy of any of the drugs
Patient not planned for extubation after the surgery
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Duration of Analgesia  24 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
VAS At different time intervals  0,2,4,6,8,10,12,14,16,18,20,22,24 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   30/04/2019 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not yet published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

Management of acute post-operative pain has received keen attention in recent years with considerable concurrent advancement in the field. Major abdominal surgeries with upper abdominal incisions lead to severe abdominal pain, which if treated inadequately, can cause shallow breathing, atelectasis, retention of secretions and lack of cooperation in physiotherapy. This increases the incidence of post-operative morbidity and leads to delayed recovery. The choice of post-operative analgesic modality employed after major abdominal surgeries at our university hospital is at the discretion of the primary anesthesiologist responsible for managing the patient in the operating room. The choice mainly depends upon the strategy favored by the concerned anesthesiologist and the availability of drugs and equipment. The supply of drugs is erratic and the quantity of equipment might not be sufficient for every patient. With these objectives in mind and in this era of opioid free analgesia, we designed this prospective observational study to evaluate postoperative pain in patients undergoing upper abdominal surgery with local anaesthetics bupivacaine and ropivacaine with NMDA adjuvant; magnesium sulphate.

So far, there are no clinical studies comparing the efficacy of magnesium sulfate when combined with local anesthetic agents, such as bupivacaine and ropivacaine for upper abdominal surgical site infiltration. The objective of this study is to assess and compare the effectiveness and safety of local infiltration of bupivacaine combined with magnesium sulfate and ropivacaine combined with magnesium sulfate for postoperative analgesia in patients undergoing upper abdominal surgery. 
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