| CTRI Number |
CTRI/2025/02/080792 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing pain relief using two different volumes and concentrations of local anaesthetic for ultrasound guided transverse abdominis plane block in patients having laparoscopic Gall bladder removal. |
|
Scientific Title of Study
|
Study on analgesic effectiveness of ultrasound guided transverse abdominis plane block using different volumes and concentrations of levobupivacaine in 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 Sumedha Dhar |
| Designation |
Post Graduate Trainee |
| Affiliation |
Bankura Sammilani Medical College and Hospital |
| Address |
Department of Anaesthesiology, Bankura Sammilani Medical College,Lokepur, Post Office-Kenduadihi,Bankura,Pin-722102
West Bengal
India
Bankura
WEST BENGAL
722102
India |
| Phone |
8016896010 |
| Fax |
|
| Email |
sumedhadhar17091995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Debasish Saha |
| Designation |
Professor and Head of Department |
| Affiliation |
Bankura Sammilani Medical College and Hospital |
| Address |
Department of Anaesthesiology, Bankura Sammilani Medical College,Lokepur, Post Office-Kenduadihi,Bankura,Pin-722102
West Bengal
Bankura
WEST BENGAL
722102
India |
| Phone |
9434100947 |
| Fax |
|
| Email |
drdebasishsaha1965@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sayak Patra |
| Designation |
Assistant Professor |
| Affiliation |
Bankura Sammilani Medical College and Hospital |
| Address |
Department of Anaesthesiology, Bankura Sammilani Medical College,Lokepur, Post Office-Kenduadihi,Bankura,Pin-722102
West Bengal
Bankura
WEST BENGAL
722102
India |
| Phone |
9433273012 |
| Fax |
|
| Email |
sayak.bank@gmail.com |
|
|
Source of Monetary or Material Support
|
| Office to Principal,Bankura Sammilani Medical College,Lokepur, Post Office-Kenduadihi,Bankura,Pin-722102
West Bengal |
|
|
Primary Sponsor
|
| Name |
Bankura Sammilani Medical Collge |
| Address |
Department of Anaesthesiology, Bankura Sammilani Medical College,Lokepur, Post Office-Kenduadihi,Bankura,Pin-722102
West Bengal |
| 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 Sumedha Dhar |
Bankura Sammilani Medical College and Hospital |
Department of Anaesthesiology, Bankura Sammilani Medical College,Lokepur, Post Office-Kenduadihi,Bankura,Pin-722102
West Bengal
Bankura
WEST BENGAL |
8016896010
sumedhadhar17091995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE OF BANKURA SAMMILANI MEDICAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
TAP-20ml local anaesthetic |
20 ml local anaesthetic( 10ml of 0.5% levobupivacaine with 10 ml saline solution) injected in the transverse abdominis plane under ultrasound guidance using 21 gauge Stimuplex needle |
| Comparator Agent |
TAP-30ml local anaesthetic |
30 ml local anaesthetic(10ml of 0.5% levobupivacaine with 20 ml saline solution) injected in the transverse abdominis plane under ultrasound guidance using 21 gauge Stimuplex needle. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients belonging to ASA Grade I to ASA Grade II.
2.Patients scheduled for elective laparoscopic cholecystectomy under General Anaesthesia with endotracheal intubation.
|
|
| ExclusionCriteria |
| Details |
1.Patients not willing to give consent to the above study.
2.Patients with cardiac, endocrinological or neurological disease
3.Patients with coagulation disorders
4.Patients with a history of known allergy to study drugs.
5.Lap cholecystectomies converted to open cholecystectomies.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.To compare the duration of postoperative analgesia obtained in the two study groups. |
minutes to hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the pain score in the two study groups
2. To study haemodynamic changes after transverse abdominis plane infiltration of Levobupivacaine in the two study groups.
|
5min,10min,15min,30min,45min,60min, 12hr,24hr |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
28/02/2025 |
| 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="3"
Days="7" |
|
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
|
A comparative study on analgesic effectiveness of two different volumes and concentrations of levobupivacaine for ultrasound-guided Transverse Abdominis Plane block to be conducted on patients undergoing laparoscopic cholecystectomy.The patients will be given General anaesthesia followed by Transverse Abdominis Plane block with 20ml of local anaesthetic (10ml 0.5% levobupivacaine and 10ml sterile water) in Group A and 30 ml of local anaesthetic (10ml 0.5% levobupivacaine and 20 ml sterile water)in Group B. Both Groups will be compared intraoperatively for analgesia using hemodynamic parameters and use of fentanyl and will be compared postoperatively by checking VAS score at 20min,12h and 24h, first time of requirement of analgesic and total analgesic used. |