Analgesic Efficacy of Rhomboid Intercostal Nerve Block for Minimal Invasive Heart Surgery

Analgesic Efficacy of Rhomboid Intercostal Nerve Block for Minimal Invasive Heart Surgery: A Randomized Controlled Clinical Trial

The goal of this clinical trial is to test the analgesic efficacy of rhomboid intercostal nerve block (RINB) in patients undergoing minimal invasive heart surgery (MIHS). The main questions it aims to answer are:

• How will the total perioperative opioid consumption of the patients receiving RINB change?
• How will RINB effect the patients' numeric rating scores for pain in the postoperative 24-hour period?
• How will RINB effect the postoperative extubation times?
• How will RINB effect the length of intensive care unit (ICU) stays on the postoperative period?
• How will RINB effect the incidence of opioid related side effects?

Participants will be divided in two groups:

• Block group will receive a RINB before the surgery.
• Control group will not receive any nerve block. Researchers will compare the results between the groups to see the postoperative effects concerning opioid consumption as well as the pain scores, respiratory parameters and ICU length of stay of the patients receiving RINB for minimal invasive heart surgery.

The hypothesis of this study is that participants receiving RINB for MIHS will have a less total opioid consumption 24 hours postoperatively.

Study Overview

• Status: Recruiting
• Conditions: Minimal Invasive Heart Surgery; Rhomboid Intercostal Nerve Block
• Intervention / Treatment: Procedure: Rhomboid Intercostal Nerve Block

Detailed Description

Rhomboid intercostal nerve block (RINB) was first defined by Elsharkawy et al in 2016 proposing to provide analgesia for both the anterior and posterior hemithorax. Minimal invasive heart surgeries require a surgical incision of the lateral thoracic wall. In order to ease the postoperative pain of patients undergoing MIHS, some regional anaesthesia techniques have been tried but there is no consensus on the best method. This study aims to assess the analgesic efficacy of RINB for MIHS. The hypothesis is that participants receiving RINB for MIHS will have a less total opioid consumption 24 hours postoperatively. Also, the postoperative pain scores, respiratory parameters and ICU length of stay of the participants will be recorded. Participants will be divided in two groups. The block-group will receive a RINB preoperatively in the operating room. The control-group will not receive any nerve block. The participants will be followed 24 hours postoperatively and their total opioid consumption, numeric rating scores for pain, postoperative extubation times, length of ICU stays, incidence of opioid related side effects will be recorded. Also the participants and the surgical teams perioperative pain related satisfaction will be evaluated.

• Study Type: Interventional
• Enrollment (Estimated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kamil Darçın, MD; Phone Number: +90 505 589 50 99; Email: kdarcin@ku.edu.tr
• Study Contact Backup: Name: Yasemin Sincer, MD; Email: sincer.yasemin@gmail.com

Study Locations

• Turkey
  • İstanbul, Turkey, 34010
    • Recruiting
    • Koc University
    • Contact: Kamil Darçın; Phone Number: +905055895099; Email: kdarcin@ku.edu.tr
    • Contact: Yasemin Sincer; Phone Number: +90512040834; Email: sincer.yasemin@gmail.com
    • Principal Investigator: Kamil Darçın

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients between the age of 18-80 undergoing minimal invasive heart surgery

Exclusion Criteria:

• Allergy to local anaesthetics
• Chronic opioid use history
• Patients with psychiatric disorders
• Patients who are not open to communication
• Patients with chronic organ failure
• Patients that do not give consent
• Patients that need emergency surgery within the first 24 hours of the initial surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Block group; Participants who will be receiving a rhomboid intercostal nerve block	Procedure: Rhomboid Intercostal Nerve Block; Before the induction of general anesthesia, under aseptic conditions, rhomboid intercostal nerve block will be performed with a single dose of 20 ml of %0,25 bupivacaine with ultrasound guidance, by the senior anaesthesiologist.
No Intervention: Control group; Participant who will not be receiving any intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total opioid consumption	all consumed opioids will be converted in morphine equivalents and then added to reach the total dosage	24 hours post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric rating scale scores for pain	the scale between 0: no pain and 10:highes pain answered by the participants	24 hours post-surgery
Extubation time after surgery	measured in hours	24 hours post-surgery
Length of intensive care unit stay	measured in hours	1 week follow up after surgery
Opioid related side effects	Nausea, vomiting, pruritis, respiratory depression assessed by yes/no questions	24 hours post surgery

Collaborators and Investigators

• Sponsor: Koç University
• Investigators: Study Director: Kamil Darçın, MD, Koc University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: May 7, 2023
• First Submitted That Met QC Criteria: May 7, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: cardiac anesthesia; rhomboid intercostal nerve block; minimal invasive heart surgery
• Other Study ID Numbers: 2022.462.IRB1.182

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Starting from 6 months after publication for 5 years
• IPD Sharing Access Criteria: no access criteria
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No