| CTRI Number |
CTRI/2024/10/075959 [Registered on: 28/10/2024] Trial Registered Prospectively |
| Last Modified On: |
22/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparision of two approaches of nerve block for pain relief after Laparoscopic gall bladder removal surgery |
|
Scientific Title of Study
|
Comparison of External Oblique Intercostal Block with Subcostal Transversus Abdominis plane Block for Postoperative Analgesia in Laparoscopic Cholecystectomy
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1311-7207 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Purvika Singh |
| Designation |
Junior Resident |
| Affiliation |
Teerthanker Mahaveer Medical College and Research Centre |
| Address |
Room No. 117 Department Of Anaesthesia Teerthanker Mahaveer
Medical College and Research Centre N.H.-24, Delhi Road,
Moradabad - 244001, Uttar Pradesh
Moradabad
UTTAR PRADESH
244001
India
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9068152305 |
| Fax |
|
| Email |
purvikasingh.singh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukesh Kumar Prasad |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer Medical College and Research Centre |
| Address |
Room No. 117 Department Of Anaesthesia Teerthanker Mahaveer
Medical College and Research Centre N.H.-24, Delhi Road,
Moradabad - 244001, Uttar Pradesh
Moradabad
UTTAR PRADESH
244001
India
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9837624543 |
| Fax |
|
| Email |
mukeshkumar2002@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukesh Kumar Prasad |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer Medical College and Research Centre |
| Address |
Room No. 117 Department Of Anaesthesia Teerthanker Mahaveer
Medical College and Research Centre N.H.-24, Delhi Road,
Moradabad - 244001, Uttar Pradesh
Moradabad
UTTAR PRADESH
244001
India
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9837624543 |
| Fax |
|
| Email |
mukeshkumar2002@gmail.com |
|
|
Source of Monetary or Material Support
|
| Teerthanker Mahaveer Medical College and Research Centre, Delhi road,Moradabad 244001 , Uttar Pradesh,India |
|
|
Primary Sponsor
|
| Name |
Teerthanker Mahaveer Medical College and research Centre |
| Address |
Teerthanker Mahaveer Medical College and Research Centre,
N.H.-24, Delhi Road, Moradabad - 244001, Uttar Pradesh |
| 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 Purvika Singh |
Teerthanker Mahaveer Medical college and Research centre |
Room no 4, Main OT Complex,Department of
Anaesthesia, Teerthanker
Mahaveer Medical College
and Research Centre
Moradabad
UTTAR PRADESH
Moradabad
UTTAR PRADESH |
9068152305
purvikasingh.singh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Teerthanker Mahaveer University-Institutional Ethics Committee |
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 |
| Comparator Agent |
Group 2 -Transversus abdominis plane block |
Dose-20ml 0.25% Bupivacaine Injection in fascial plane
Frequency- once before extubation
Duration-VAS score and haemodynamic parameter will be recorded at the end of surgery
|
| Intervention |
Group I- Ultrasound guided EOIB |
Dose-20ml 0.25% Bupivacaine Injection in fascial plane
Frequency- once before extubation
Duration-VAS score and haemodynamic parameter will be recorded at the end of surgery
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1-Patients posted for Elective Laparoscopic 2-Cholecystectomy (Cholelithiasis and Cholecystitis) giving informed and written consent
3-Patients of age 18-70 years
4-American Society of Anesthesiologist (ASA) physical status I-II
|
|
| ExclusionCriteria |
| Details |
1-H/o coagulopathy
2-History of chronic alcohol abuse / drug abuse
3-Allergy to local anaesthetic
4-BMI ≥35kg/m2
5-Pregnant patients
6-All other indications of laparoscopic cholecystectomy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate tramadol consumption for postoperative 24 hours in both the groups |
To evaluate tramadol consumption for postoperative 24 hours in both the groups, 0 min, 15 min, 30 min, 1 hour, 2 hour, 4 hour, 8 hour, 12 hour,16 hour, 24 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1-To compare VAS score postoperatively.
2-To compare total consumption of analgesics in 24 hours post operatively.
3-To compare hemodynamical parameters.
4-To observe any complications |
0 mins, 15 mins, 30 mins, 45 mins ,1st hours, 2 hours, 4hours, 8hours, 12hours, 16hours, 20 hours 24hours. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/11/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/04/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
After getting approval from College Research Committee (CRC) and Institutional Ethical Committee (IEC), TMMC & RC
All Patients meeting our inclusion & exclusion criterions will be studied
Patients will be randomly allocated into two groups : E-External oblique intercoastal block[EOIB] and T-Subcostal transversus abdominis plane block [STAP]
General anaesthesia will be given as per the institution’s protocol
After surgery before extubation : Group E- Ultrasound guided EOIB 20ml Bupivacaine 0.25% and Group T- Ultrasound guided STAP 20ml Bupivacaine 0.25%
The patient will be shifted to PACU and standard analgesia (1 gm PCM 8 hourly I. V.) will be given as per institute protocol.
VAS score and hemodynamic parameter will be recorded at the end of surgery 30mins , 45mins then 1st hour, 2nd hour ,6th hour, 12th hour, 16th hour, 20th hour, and 24th hour.
VAS >4 will be given rescue analgesia in form of I/V Tramadol 1mg/kg.
Total rescue analgesic consumption in 24 hours and complications will be noted.
Data will be analysed using the appropriate statistical method. |