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CTRI Number  CTRI/2025/02/080575 [Registered on: 14/02/2025] Trial Registered Prospectively
Last Modified On: 05/02/2025
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   Comparative study between injecting local anesthetic Ropivacaine 0.2 percent and Bupivacaine 0.25 percent in the chest wall fascial plane for Post-operative Analgesia in patients undergoing upper abdominal surgeries 
Scientific Title of Study   Comparison of external oblique intercostal plane block with Ropivacaine 0.2 percent and Bupivacaine 0.25 percent for postoperative pain management in upper abdominal surgeries 
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 Darshan Vegada 
Designation  Junior Resident 
Affiliation  D Y PATIL MEDICAL COLLEGE AND RESEARCH INSTITUTE 
Address  Department of Anesthesiology First floor D Y PATIL MEDICAL COLLEGE AND RESEARCH INSTITUTE KOLHAPUR Kolhapur Maharashtra 416003 India

Kolhapur
MAHARASHTRA
416003
India 
Phone  9104400077  
Fax    
Email  vegdadarshan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sandeep Kadam 
Designation  Professor and head of department  
Affiliation  D Y PATIL MEDICAL COLLEGE AND RESEARCH INSTITUTE 
Address  Department of Anesthesiology First floor D Y PATIL MEDICAL COLLEGE AND RESEARCH INSTITUTE KOLHAPUR Kolhapur Maharashtra 416003 India

Kolhapur
MAHARASHTRA
416003
India 
Phone  9922447500  
Fax    
Email  kadamsandeeps@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Darshan Vegada 
Designation  Junior Resident 
Affiliation  D Y PATIL MEDICAL COLLEGE AND RESEARCH INSTITUTE 
Address  Department of Anesthesiology First floor D Y PATIL MEDICAL COLLEGE AND RESEARCH INSTITUTE KOLHAPUR Kolhapur Maharashtra 416003 India

Kolhapur
MAHARASHTRA
416003
India 
Phone  9104400077  
Fax    
Email  vegdadarshan@gmail.com  
 
Source of Monetary or Material Support  
D Y PATIL HOSPITAL, KADAMWADI, KOLHAPUR 416003 MAHARSHTRA INDIA 
 
Primary Sponsor  
Name  Dr Darshan Vegada 
Address  D Y PATIL MEDICAL COLLEGE AND RESEARCH INSTITUE Kadamwadi Kolhapur 416003 Maharashtra India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Darshan Vegada  D Y PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE   Department of Anesthesiology First floor D Y PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE Kadamwadi Kolhapur 416003 Maharashtra India
Kolhapur
MAHARASHTRA 
9104400077

vegdadarshan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE D Y PATIL MEDICAL COLLEGE KOLHAPUR   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 3||Administration,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  External Oblique Intercostal Fascial Plane block with Bupivacaine 0.25%   Use of Bupivacaine 0.25% for post operative pain management in upper abdominal surgeries. To study pain score on Visual Analogue Scale (VAS) post-operatively in upper abdominal surgeries in first 24 hours after administration of external oblique intercostal block with Bupivacaine 0.25%. 
Intervention  External Oblique Intercostal Fascial Plane block with Ropivacaine 0.2%   Use of Ropivacaine 0.2% for post operative pain management in upper abdominal surgeries. To study pain score on Visual Analogue Scale (VAS) post-operatively in upper abdominal surgeries in first 24 hours after administration of external oblique intercostal block with Ropivacaine 0.2%.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Adult patients scheduled for elective upper
abdominal surgeries.
2 Patients who have given informed valid written
consent
3 ASA GRADE I AND II
 
 
ExclusionCriteria 
Details  1 Adult patients scheduled for emergency upper
abdominal surgeries.
2 All patients who are not willing for the study
3 Skin infection at the puncture site.
4 Allergic to Local Anesthetic agents.
5 Pregnant female patients
6 Patient with coagulopathy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the duration and quality of analgesia provided by ropivacaine 0.2% and bupivacaine 0.25% in external oblique intercostal plane block for upper abdominal surgeries by pain scores on Visual Analogue Score (VAS) post operatively .  Visual Analogue Score (VAS) will be observed at 2 hours, 4 hours,6 hours, 8 hours, 12 hours, 16 hours, 20 hours and 24 hours interval. 
 
Secondary Outcome  
Outcome  TimePoints 
1 To asses and compare the opioid consumption between patients receiving ropivacaine 0.2% and bupivacaine 0.25% for external oblique intercostal plane block in 24 hours.
2 To determine the incidence of adverse effects associated with ropivacaine 0.2% and bupivacaine 0.25% in external oblique intercostal plane block.
 
Visual Analogue Score (VAS) will be observed at 2 hours, 4 hours,6 hours, 8 hours, 12 hours, 16 hours, 20 hours and 24 hours interval.  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   17/02/2025 
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="2"
Months="0"
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  

INTRODUCTION

Upper abdominal surgeries often result in significant postoperative pain, which can lead to delayed recovery and increased morbidity. Effective pain management strategies are crucial to enhance patient comfort and facilitate early mobilization.[1] One promising technique is the external oblique intercostal plane (EOICP) block, which involves the administration of local anesthetics into the plane between the external oblique muscle and the intercostal muscles. This technique provides analgesia to the anterior abdominal wall, making it particularly suitable for upper abdominal surgeries. [2-5]

The choice of local anesthetic agent is a critical factor in the success and safety of EOICP block. Ropivacaine and bupivacaine are commonly used local anesthetics for regional anesthesia. Ropivacaine, a long-acting amide local anesthetic, offers a favorable safety profile with reduced cardiotoxicity compared to bupivacaine. It provides effective analgesia with a lower risk of systemic toxicity, making it an attractive option for EOICP block. On the other hand, bupivacaine, a long-acting local anesthetic, provides prolonged analgesia but carries a higher risk of cardiotoxicity. [5-7]

Several studies have investigated the efficacy and safety of ropivacaine and bupivacaine for various regional anesthesia techniques. [5,6,1] However, there is a paucity of data specifically comparing these two agents for EOICP block in upper abdominal surgeries. Understanding the comparative analgesic efficacy and adverse effects of ropivacaine 0.2% and bupivacaine 0.25% in this context is crucial for optimizing pain management strategies. Therefore, the present study is undertaken to study and compare the analgesic efficacy and adverse effects of ropivacaine 0.2% and bupivacaine 0.25% when used for EOICP block in upper abdominal surgeries. By evaluating the duration and quality of analgesia, opioid consumption and incidence of adverse effects, we can determine the optimal local anesthetic agent for EOICP block in this specific surgical population.

NEED FOR STUDY

This study on external oblique intercostal plane block comparing Ropivacaine 0.2% and Bupivacaine 0.25% for upper abdominal surgeries is crucial to optimize postoperative pain management. Given the significant pain associated with these surgeries, exploring the efficacy of these local anesthetics can help minimize opioid consumption and related side effects. Tailoring anesthetic approaches based on the characteristics of Ropivacaine and Bupivacaine is important for patient-centred care and improved recovery outcomes. Assessing the duration of analgesia and addressing gaps in the existing literature contributes to advancing evidence-based practice in upper abdominal surgery pain management.

AIM:

To compare the analgesic efficacy and adverse effects of ropivacaine 0.2% and bupivacaine 0.25% when used for external oblique intercostal plane (EOICP) block in upper abdominal surgeries.

OBJECTIVES:

  • To assess the duration and quality of analgesia provided by ropivacaine 0.2% and bupivacaine 0.25% in EOICP block for upper abdominal surgeries.
  • To Assess the opioid consumption between patients receiving ropivacaine 0.2% and bupivacaine 0.25% for EOICP block in 24 hours.
  • To compare the duration and quality of analgesia between ropivacaine 0.2% and bupivacaine 0.25% in EOICP block for upper abdominal surgeries.
  • To compare the opioid consumption between patients receiving ropivacaine 0.2% and bupivacaine 0.25% for EOICP block in 24 hours.
  • To determine the incidence of adverse effects associated with ropivacaine 0.2% and bupivacaine 0.25% in EOICP block.

 

Research design and Detailed methodology:

All the patients matching my inclusion criteria will be selected and the study protocol will be explained in detail and informed valid written consent will be obtained from patients.

Consented study participants will be randomized into 2 groups with 15 participants each by simple randomization using a computerized randomized method.

Both in the group will receive Inj. Paracetamol 1 gm IV TID and a standard dose of Inj. Tramadol 100 mg IV as a rescue analgesic whenever the patient complains of pain and his VAS Score is >3.

Patients in both groups will receive the same Pre-medication before the procedure and standard anaesthetic protocol and technique will be followed by administering a standard volume of 20 cc drug on each side. External oblique intercostal plane block will be given under USG guidance by consultant anaesthesiologist according to Randomization.   

Group A- Inj. Ropivacaine 0.2%. 40 ml (20ml on each side)

Group B- Inj. Bupivacaine 0.25%. 40 ml (20ml on each side)

The baseline demographic and clinical characteristics of the patients will be recorded. The primary outcome measure, the duration of analgesia, will be assessed by recording the time from the initiation of the block to the first request for rescue analgesia. Secondary outcome measures will include opioid consumption, assessed by recording the total amount of opioids administered during the first 24 hours postoperatively, and the incidence of adverse effects such as local anesthetic toxicity, systemic toxicity, and other complications. Postoperative pain will be assessed using a VAS score at regular intervals for both drugs.

 

REFERENCE:

  1. Korkusuz M, Basaran B, Et T, Bilge A, Yarimoglu R, Yildirim H. Bilateral external oblique intercostal plane block (EOIPB) in patients undergoing laparoscopic cholecystectomy: A randomized controlled trial. Saudi Medical Journal. 2023 Oct;44(10):1037.
  2. Elsharkawy H, Kolli S, Soliman LM, Seif J, Drake RL, Mariano ER, El-Boghdadly K. The external oblique intercostal block: anatomic evaluation and case series. Pain Medicine. 2021 Nov 1;22(11):2436-42.
 
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