| CTRI Number |
CTRI/2024/10/074565 [Registered on: 01/10/2024] Trial Registered Prospectively |
| Last Modified On: |
29/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparison of 2 medicine for postoperative pain relief |
|
Scientific Title of Study
|
Comparative evaluation of intraperitoneal instillation of bupivacaine with magnesium sulphate versus bupivacaine with dexmedetomidine for post operative relief after laparoscopic cholecystectomy |
| 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 Aditi Raj Singh |
| Designation |
Junior Resident |
| Affiliation |
Lala Lajpat Rai Memorial Medical College Meerut |
| Address |
Department of anaesthesia, Lala Lajpat Rai Memorial Medical College, Meerut, Uttar Pradesh India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
7895889556 |
| Fax |
|
| Email |
krati1796@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subhash Dahiya |
| Designation |
Professor |
| Affiliation |
Lala Lajpat Rai Memorial Medical College Meerut |
| Address |
Department of anaesthesia, Lala Lajpat Rai Memorial Medical College, Meerut, Uttar Pradesh, India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9837056949 |
| Fax |
|
| Email |
drsubhashllrm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aditi Raj Singh |
| Designation |
Junior Resident |
| Affiliation |
Lala Lajpat Rai Memorial Medical College Meerut |
| Address |
Department of anaesthesia,
Lala Lajpat Rai Memorial Medical College, Meerut, Uttar Pradesh, India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
7895889556 |
| Fax |
|
| Email |
krati1796@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia LLRM medical college meerut 250004 |
|
|
Primary Sponsor
|
| Name |
LLRM medical College |
| Address |
Department of Anaesthesia, LLRM medical college, meerut, uttar pradesh 250004 |
| Type of Sponsor |
Government medical college |
|
|
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 Aditi Raj Singh |
LLRM medical college meerut |
Department of anaesthesia LLRM medical college meerut uttar pradesh
Meerut
UTTAR PRADESH |
7895889556
krati1796@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K80||Cholelithiasis, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inj. Bupivacaine with Dexmedetomidine |
Inj. Bupivacaine 20ml of 0.25% plus 1mcg/kg of Dexmedetomidine to total volume of 30ml to be given intraperitoneally. |
| Comparator Agent |
Inj. Bupivacaine with magnesium sulphate
|
Inj. Bupivacaine 20ml of 0.25% plus 50mg/kg of magnesium sulphate to total volume of 30ml to be given intraperitoneally. |
| Intervention |
Intraperitoneal instillation |
Drug is instilled intraperitoneally in all the participants of the study. We observe patient for 24 hours post operatively |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade 1 And 2
Age 18-65 Yrs
Patients Undergoing Elective Laparoscopic Cholecystectomy surgery
Patients With Informed Consent |
|
| ExclusionCriteria |
| Details |
Patients With ASA Grade 3 And 4
Known Allergy Or Hypersensitivity To Local Anaesthetic Drug
Pregnancy, Patients With Asthma Or Chronic Lung Disease, Patients With Heart Disease, Patients With Renal Failure And Dialysis
Patient Refusal |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the efficacy and the quality of analgesia.
|
Postoperatively pain will be assessed at different time intervals for initial 24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Timing of requiring first dose of rescue analgesic |
Patient to be assessed for 24 hours post operatively |
| Total analgesic consumption in 24 hours |
Patient to be assessed for 24 hours post operatively |
| Assess hemodynamic changes |
Patient to be assessed for 24 hours post operatively at different time intervals |
| Complications if any |
Patient to be assessed for 24 hours post operatively |
|
|
Target Sample Size
|
Total Sample Size="116"
Sample Size from India="116"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/10/2024 |
| 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="4"
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 study is prospective randomised study for comparative evaluation of intraperitoneal instillation of bupivacaine with magnesium sulphate versus bupivacaine with dexmedetomidine for post operative relief after laparoscopic cholecystectomy.
Also will be assessing the timing of requiring first dose of rescue analgesic, total dose of rescue analgesia required, hemodynamic changes and complications if any during post operative period. |