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Clinical Trials/CTRI/2025/02/080575
CTRI/2025/02/080575
Not yet recruiting
Not Applicable

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

Dr Darshan Vegada1 site in 1 country30 target enrollmentStarted: February 17, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Dr Darshan Vegada
Enrollment
30
Locations
1
Primary Endpoint
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 .

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1 Adult patients scheduled for elective upper abdominal surgeries.
  • 2 Patients who have given informed valid written consent 3 ASA GRADE I AND II.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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 .

Time Frame: 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 Outcomes

  • 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.)

Investigators

Sponsor
Dr Darshan Vegada
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Darshan Vegada

D Y PATIL MEDICAL COLLEGE AND RESEARCH INSTITUTE

Study Sites (1)

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