| CTRI Number |
CTRI/2021/12/038916 [Registered on: 24/12/2021] Trial Registered Prospectively |
| Last Modified On: |
25/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to see if adding magnesium sulphate to local anaesthetic in abdominal block decreases pain after gall bladder surgery |
|
Scientific Title of Study
|
Magnesium sulphate as adjuvant to ropivacaine in bilateral transversus abdominis plane block for laproscopic cholecystectomy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Wasim Mohammad Bhat |
| Designation |
Lecturer Anaesthesiology |
| Affiliation |
SKIMS Medical College Bemina |
| Address |
Department of Anaesthesia, SKIMS Medical College Bemina,Srinagar, J & K,India
Srinagar
JAMMU & KASHMIR
190018
India |
| Phone |
7006142879 |
| Fax |
0194-2490071 |
| Email |
wmb914@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Wasim Mohammad Bhat |
| Designation |
Lecturer Anaesthesiology |
| Affiliation |
SKIMS Medical College Bemina |
| Address |
Department of Anaesthesia, SKIMS Medical College Bemina,Srinagar, J & K,India
Srinagar
JAMMU & KASHMIR
190018
India |
| Phone |
7006142879 |
| Fax |
0194-2490071 |
| Email |
wmb914@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Wasim Mohammad Bhat |
| Designation |
Lecturer Anaesthesiology |
| Affiliation |
SKIMS Medical College Bemina |
| Address |
Department of Anaesthesia, SKIMS Medical College Bemina,Srinagar, J & K,India
Srinagar
JAMMU & KASHMIR
190018
India |
| Phone |
7006142879 |
| Fax |
0194-2490071 |
| Email |
wmb914@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, Skims Medical College
Hospital,Bemina, Srinagar 190018, J & K, India |
|
|
Primary Sponsor
|
| Name |
Govt SKIMS Medical College Hospital |
| Address |
SKIMS Medical College Hospital Bemina Srinagar J and K India |
| 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 Wasim Mohammad Bhat |
Skims Medical College Hospital Bemina |
Department of Anaesthesia, General Surgery Operation Room
Srinagar
JAMMU & KASHMIR |
7006868235
wmb914@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Skims Medical College Bemina Srinagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (19.5 ml of 0.2 % ropivacaine plus 0.5 ml Magnesium sulphate 50%) |
Drug: Ropivacaine plus Magnesium sulphate.Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (19.5 ml of 0.2 % ropivacaine plus 0.5 ml of 50 % Magnesium sulphate)
Total duration of therapy will be 2 to 5 minutes. |
| Comparator Agent |
Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (19.5 ml of 0.2 % ropivacaine plus 0.5 ml NS).
|
Drug: Ropivacaine +Normal saline.
Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (19.5 ml of 0.2 % ropivacaine plus 0.5 ml Normal saline).
Total duration of therapy will be 2 to 5 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged 18-65 years undergoing laparoscopic cholecystectomy |
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.Patients with a history of cardiac, or respiratory diseases (>ASA III).
3.Patients with allergy to amide local anesthetics or medication included in the study.
4.Infection at the needle insertion site.
5.Pregnancy
6.BMI >35
7.Drug abusers
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The post-operative pain during first 24 hours after surgery using Visual analogue scale. |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time to first dose of post-operative analgesia and total diclofenac consumption in 24 hours
2. Post-operative nausea and vomiting
3. Sedation
4. Patient satisfaction
|
24 hours |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 |
|
Date of First Enrollment (India)
|
01/01/2022 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is a prospective randomised controlled trial to assess the effect of adding magnesium sulphate as adjuvant to ropivacaine in ultrasound guided transversus abdominis plane block in laproscopic cholecystectomy.The study is planned for 80 patients.The primary outcome measure is post-operative pain during the first 24 hours after surgery using visual analogue scale.Secondary outcome measures are time to first dose of post-operative analgesia and total diclofenac consumption in 24 hours, post-operative nausea and vomiting,sedation,patient satisfaction. |