| 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
|
|
|
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
|
|
|
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:
- 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.
- 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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