| CTRI Number |
CTRI/2024/08/073051 [Registered on: 28/08/2024] Trial Registered Prospectively |
| Last Modified On: |
22/08/2024 |
| 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
|
Estimating the result of regional anesthesia for pain management post laparoscopy cholecystectomy adult group of patients |
|
Scientific Title of Study
|
Effect of External Oblique Intercostal plane block and Rectus Abdominis plane block for postoperative pain in patient of laparoscopic cholecystectomy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1311-0108 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gami meetkumar vrajlal |
| Designation |
Junior resident |
| Affiliation |
Teerthanker Mahaveer Medical College and Research Centre |
| Address |
Room No. 211 Department Of Anaesthesia Teerthanker Mahaveer Medical College and Research Centre N.H.-24, Delhi Road, Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9979756561 |
| Fax |
|
| Email |
meetgami77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MD Shahbaz Alam |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer Medical College and Research Centre |
| Address |
Room No. 211 Department Of Anaesthesia Teerthanker Mahaveer
Medical College and Research Centre N.H.-24, Delhi Road,
Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9897907372 |
| Fax |
|
| Email |
dralamshahbaz006@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MD Shahbaz Alam |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer Medical College and Research Centre |
| Address |
Room No. 211 Department Of Anaesthesia Teerthanker Mahaveer Medical College and Research Centre N.H.-24, Delhi Road, Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9897907372 |
| Fax |
|
| Email |
dralamshahbaz006@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 Gami Meetkumar |
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 |
9979756561
meetgami77@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 |
Placebo group |
iv analgesics (Paracetamol & Tramadol) |
| Intervention |
Regional anesthesia |
Regional anesthesia blocks will be perform post laparoscopy cholecystectomy for pain management |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient posted for elective laparoscopic cholecystectomy giving informed and written consent
2. Patients of age 18-70 years.
3. BMI from 18.5 kg/m2 to 25 kg/m2
4.American Society of Anesthesiologists (ASA) physical status I-II patients. |
|
| ExclusionCriteria |
| Details |
1.Coagulation disorders, liver/kidney disease.
2. Local infection at site of block.
3. Ho/ alergy ot study medications
4.Pregnancy.
5.Chronic alcohol and drug abuse. |
|
|
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 group |
To evaluate tramadol consumption for postoperative 24 hours in both the group |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the Numeric Rating Scale (NRS) scores for postoperative 24 hours in both the group.
2.To evaluate the post operative recovery time in both the groups.
|
15 minute,30 minute, 60 minute, 2 hours, 6 hours, 12 hours, 24 hours |
|
|
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)
|
11/08/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/12/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 Permission from College Research Committee (CRC) and Institutional Ethical Committee (IEC), TMMC&RC, Moradabad
Randomization will be done by computer generated techniques and patients will be assigned in to two group
Group A : External oblique intercostal block (20 ml of 0.25% bupivacaine) and rectus abdominis (20 ml of 0.25% bupivacaine) Group B : IV analgesic will be administered as standard institutional protocol
After shifting the patient to operating room ASA monitor will be attached baseline values of heart rate (HR) Systolic blood pressure (SBP) Diastolic blood pressure (DBP) and oxygen saturation will be recorded
General anesthesia with endotracheal intubation will be administered according to standard protocol
EOIPB & RA will be administered by anesthesiologist after extubation.
Postoperative analgesia all patients were given INJ PCM 15mg/kg 8 hourly will be given , will be given first application of analgesic drug was administered after anesthesia induction. NRS, Modified Aldrete’s Score will be assessed simultaneously
In postoperative period patients will be assessed for pain by numeric rating scale (NRS) • NRS will be recorded at 15, 30, 60 minutes in PACU and 2,6,12,24 hours • In the NRS evaluation 0 = no pain , 10 = worst pain • Intravenous tramadol 50 mg ( rescue analgesia) will be given and recorded when the pain >= 4on NRS
The recovery time will be considered from the last dose of drug administered till archiving Modified Aldrete’s Score of 9-10 |