| CTRI Number |
CTRI/2024/07/071108 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To see the effect of external oblique intercostal plane block on post operative pain relief in patients for laparoscopic cholecystectomy. |
|
Scientific Title of Study
|
Efficacy of bilateral external oblique intercostal plane block for postoperative pain relief in patients undergoing 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 Mamta Bhardwaj |
| Designation |
Professor |
| Affiliation |
Department of Anaesthesiology , Pandit BD Sharma PGIMS Rohtak. |
| Address |
Department of Anaesthesiology , Pandit BD Sharma PGIMS Rohtak
Rohtak
HARYANA
Rohtak
HARYANA
124001
India |
| Phone |
9812789476 |
| Fax |
|
| Email |
drbmamta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Bhardwaj |
| Designation |
Professor |
| Affiliation |
Department of Anaesthesiology , Pandit BD Sharma PGIMS Rohtak. |
| Address |
Department of Anaesthesiology , Pandit BD Sharma PGIMS Rohtak
Rohtak
HARYANA
Rohtak
HARYANA
124001
India |
| Phone |
9812789476 |
| Fax |
|
| Email |
drbmamta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aishwara Tamboli |
| Designation |
Junior Resident (postgraduate student) |
| Affiliation |
Department of Anaesthesiology , Pandit BD Sharma PGIMS Rohtak. |
| Address |
Department of Anaesthesiology , Pandit BD Sharma PGIMS Rohtak
Rohtak
HARYANA
Rohtak
HARYANA
124001
India |
| Phone |
7000118605 |
| Fax |
|
| Email |
tamboliaishwarya1234@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology , Pt B.D. Sharma PGIMS university of health sciences, Rohtak, haryana, 124001.
INDIA |
|
|
Primary Sponsor
|
| Name |
Pt BD Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology and critical care |
| 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 Aishwarya Tamboli |
Department of Anaesthesiology and critical care , Pt B.D. Sharma PGIMS Rohtak |
Department of Anaesthesiology and critical care, Pt B.D. Sharma PGIMS
Rohtak
HARYANA
Rohtak
HARYANA |
7000118605
tamboliaishwarya1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research 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 |
Local anaesthetic infiltration |
Local anaesthetic (bupivacaine 0.25%) infiltration will be done at four trocar sites and under the diaphragm on both sides at the end of the surgery (5 mins) |
| Intervention |
Ultrasound guided bilateral external oblique intercostal plane block (EOIPB) |
USG guided EOIPB will be administered at the end of surgery.It will take around 10-15 mins. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American society of Anesthesiologists (ASA) physical status I to II, scheduled to undergo Laparoscopic cholecystectomy (LC) under general anaesthesia will be included in the study. |
|
| ExclusionCriteria |
| Details |
Patients with allergy to local anaesthetics, coagulopathies, pregnancy, infection at local site, weight less than 45kg and BMI more than 35 kg/m², chronic opioid use, history of abdominal surgery, refusal to consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate analgesic consumption (tramadol and paracetamol) in the first 24 hours in both groups. |
To evaluate analgesic consumption(tramadol and paracetamol) at 30 mins, 1hr, 2hr,6hr, 12hr and 24hrs post operatively in both groups. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Postoperative pain score evaluation using visual analogue scale (VAS) in PACU at 30 min, 1 h, 2h, 6h. 12h and 24h postoperatively
2.Time of first analgesic request.
3.Postoperative Nausea and Vomiting (PONV)
4.Sedation score
5.Number of dermatomes anaesthetised.
6.Adverse effects (if any)
|
At 30 min, 1h, 2h, 6h. 12h and 24h postoperatively. |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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
|
N/A |
|
Date of First Enrollment (India)
|
02/08/2024 |
| 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="4"
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
|
Title of Study-Efficacy of bilateral external oblique intercostal plane block for postoperative pain relief in patients undergoing laparoscopic cholecystectomy. 44 patients (22 in each group), aged between 18-65 years belonging to ASA I & II scheduled to undergo laparoscopic cholecystectomy under general anaesthesia will be enrolled to compare the effect of external oblique intercostal plane block (EOIPB) and patient receiving standard multimodal analgesia. Analgesic consumption in first 24 hours, post op pain score evaluation using visual analogue scale in PACU, Time of first analgesic request, post op nausea and vomiting (PONV), sedation score, total intra operative fentanyl consumption, number of dermatomes anaesthetised, adverse effects (if any) will also be compared.
|