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
|
|
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
|
|
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. |