| CTRI Number |
CTRI/2025/09/094635 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
11/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
trial to study the analgesic efficacy of Ultrasound guided bilateral abdominal wall with local anaesthetic injection in patients undergoing laparoscopic cholecystectomy |
|
Scientific Title of Study
|
Postoperative analgesic efficacy of USG guided bilateral external oblique intercostal plane block (EOIPB) in patients undergoing laparoscopic cholecystectomy: A patient and observer blind randomized controlled intervention trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Dwivedi |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Gorakhpur |
| Address |
Department of Anaesthesia, AIIMS GKP
Department of Anaesthesiology, Pain & Critical Care Medicine
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
08795453444 |
| Fax |
|
| Email |
drpriyad1111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Priyanka Dwivedi |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Gorakhpur |
| Address |
Department of Anaesthesia, AIIMS GKP
Department of Anaesthesiology, Pain & Critical Care Medicine
UTTAR PRADESH
273008
India |
| Phone |
08795453444 |
| Fax |
|
| Email |
drpriyad1111@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Dwivedi |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Gorakhpur |
| Address |
Department of Anaesthesia, AIIMS GKP
Department of Anaesthesiology, Pain & Critical Care Medicine
UTTAR PRADESH
273008
India |
| Phone |
08795453444 |
| Fax |
|
| Email |
drpriyad1111@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Gorakhpur |
| Address |
Major OT Complex, Department of Anaesthesia, |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Priyanka Dwivedi |
OT Complex AIIMS Gorakhpur |
Department of Anaesthesia, AIIMS GKP
Department of Anaesthesiology, Pain & Critical Care Medicine
All India Institute of Medical Sciences, Gorakhpur
Gorakhpur
UTTAR PRADESH |
08795453444
drpriyad1111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional human 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 |
| Intervention |
Patients who are scheduled for elective laparoscopic cholecystectomy surgeries under general anaesthesia will be given standard analgesic regimen |
Receiving general anaesthesia and standard postoperative analgesia only. |
| Comparator Agent |
Patients who are scheduled for elective laparoscopic cholecystectomy surgeries under general anaesthesia will be given USG guided bilateral EOIP Block |
Receiving general anaesthesia followed by USG guided bilateral EOIP Block with 20 ml 0.2 % ropivacaine on each side along with standard postoperative analgesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 - 65 years old, of either sex, American Society of Anesthesiologists physical status (ASA) I and II, who are scheduled for elective laparoscopic cholecystectomy surgeries under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
•Patient’s refusal
•Known allergies to local anesthetic drugs,
•ASA Grade more than 2
•Body mass index (BMI) more than 35 Kg per m2
•Participants having difficulty in the visualization of EO muscle on USG.
•Significant cerebrovascular, cardiovascular disease, hepatic or renal dysfunction or uncontrolled systemic illness
•Known coagulation defects, or on anticoagulants
•Infection in the intended intervention site,
•Inability to communicate.
•Chronic opioid usage, having history of treatment of chronic pain condition and are on daily analgesic for more than 4 weeks.
•History of previous abdominal surgeries. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the postoperative analgesic efficacy in the form of Numeric Rating Scale (NRS) for pain (rest) |
at 6 hours post surgery/post block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • To observe the Numeric Rating Score 1 hr, 2 hrs, 4hrs, 6 hrs, 12 hrs and 24 hrs at rest and at movement. |
at 1 hr, 2 hrs, 4hrs, 6 hrs, 12 hrs and 24 hrs |
| To observe total Fentanyl consumption |
in first 24 hours in both the groups. |
| To observe postoperative quality of Recovery Score (QoR-15). |
24 hours |
| • Variations in hemodynamic parameters such as Heart rate (HR) and Blood pressure (Systolic, Diastolic, Mean) |
1 hr, 2 hrs, 4hrs, 6 hrs, 12 hrs and 24 hrs |
| • To observe the side effects and complications, if any, during and after the block procedure. |
24 hours |
|
|
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 4 |
|
Date of First Enrollment (India)
|
15/10/2025 |
| 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="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drpriyad1111@gmail.com].
- For how long will this data be available start date provided 15-10-2025 and end date provided 15-10-2026?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This randomized patient and observer blind controlled intervention trial aims to evaluate whether EOIPB provides superior pain relief compared to standard systemic opioids and NSAIDs after laparoscopic cholecystectomy. A total of 110 patients (55 per group) will be randomized to receive either standard postoperative analgesia alone or in combination with bilateral EOIPB using ropivacaine. The primary outcome is pain score at rest (NRS) at 6 hours post-surgery. Secondary outcomes include pain scores at multiple time intervals, fentanyl consumption, quality of recovery (QoR-15), hemodynamic variations, and side effects. The trial employs strict randomization and blinding methods, and the sample size has been calculated to ensure adequate power. Results are expected to provide evidence on the role of EOIPB in improving postoperative pain management, reducing opioid use, and enhancing recovery |