| CTRI Number |
CTRI/2024/03/064042 [Registered on: 12/03/2024] Trial Registered Prospectively |
| Last Modified On: |
02/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessment of postoperative pain relief in patients coming for laparoscopic abdomen surgeries using two different drugs under ultrasound guidance |
|
Scientific Title of Study
|
Assessment of postoperative analgesic effect of Bupivacaine and Magnesium sulphate vs Bupivacaine and Dexmedetomidine in ultrasound-guided Transversus abdominis plane block for all laparoscopic surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vinisha Sridhar |
| Designation |
Junior resident |
| Affiliation |
Sree Balaji medical college and hospital |
| Address |
Department of Anaesthesiology third floor
Sree Balaji medical college and hospital
Department of Anaesthesiology third floor
Sree Balaji medical college and hospital
7 clc works chrompet chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
9884484448 |
| Fax |
|
| Email |
vinishasridhar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kala Balasubramanian |
| Designation |
professor |
| Affiliation |
Sree Balaji medical college and hospital Chennai |
| Address |
Department of Anaesthesiology third floor
Sree Balaji medical college and hospital Chennai
Department of Anaesthesiology third floor
Sree Balaji medical college and hospital Chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
9444680908 |
| Fax |
|
| Email |
kalamhn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kala Balasubramanian |
| Designation |
professor |
| Affiliation |
Sree Balaji medical college and hospital Chennai |
| Address |
Department of Anaesthesiology first floor
Sree Balaji medical college and hospital
Department of Anaesthesiology first floor
Sree Balaji medical college and hospital
Chennai
TAMIL NADU
600044
India |
| Phone |
9444680908 |
| Fax |
|
| Email |
kalamhn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sree Balaji Medical College and Hospital chennai |
|
|
Primary Sponsor
|
| Name |
Sree Balaji Medical College and Hospital |
| Address |
Sree Balaji Medical College and Hospital Department of
Anaesthesiology No 7 CLC Works road chromepet chennai 44 |
| Type of Sponsor |
Private 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 Vinisha |
Sree Balaji Medical College Hospital |
Department of Anaesthesiology fourth floor Operating room complex
chrompet
chennai
Chennai
TAMIL NADU |
9884484448
vinishasridhar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN ETHICS COMMITTE (IHEC) Sree Balaji Medical College Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.25% Inj Bupivacaine and 0.5 mcg/kg Dexmedetomidine Group B |
Prospectively for the one year
duration Patients posted for
Laparoscopic abdominal surgery will be randomly taken as Group A and Group B
Group B Under sterile aseptic precautions, TAP block will be given with 20ml on each side combination of 0.25% Bupivacaine and 0.5 mcg/kg Dexmedetomidine |
| Intervention |
Injection 0.25% Inj Bupivacaine and 150 mg Magnesium sulphate Group A |
Prospectively for the one year
duration Patients posted for
Laparoscopic abdominal surgery will be randomly taken as Group A and Group B
Group A Under sterile aseptic precautions, TAP block will be given with combination of 0.25% Bupivacaine and 150 mg Magnesium sulphate |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted all laparoscopic surgeries
ASA grade 1 and ASA grade 2
patient who are willing to participate |
|
| ExclusionCriteria |
| Details |
ASA grade 3 and ASA grade 4
Patients who are known case of hypersensitivity to amide group of local anesthetic agents
Patients with coagulation disorders
patient who are not willing to participate |
|
|
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 |
| To observe the duration of analgesia between the two different study groups |
by observing hourly VAS score |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the time of first rescue analgesia |
To find out the Pain score at 4hr 8hr 12hr 18hr and 24hr postoperatively |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/04/2024 |
| 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="0"
Days="0" |
|
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
|
Patients who are fulfilling inclusion criteria will be randomly allocated to two groups based on computer generated randomisation Group A Under sterile aseptic precautions TAP block will be given with combination of 0.25% Bupivacaine and 150 mg Magnesium sulphate Group B Under sterile aseptic precautions TAP block will be given with 20ml on each side combination of 0.25% Bupivacaine and 0.5 mcg/kg Dexmedetomidine Postoperatively the patients will be monitored for vital parameters and PAIN SCORES (VAS score, NRS score) at 4h, 8h, 12h ,18h and 24 h The time of requirement of first rescue analgesia will be noted and Outcomes will be recorded for interpretation
|