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

NCT ID: NCT05861804

Last Updated: 2024-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Minimal Invasive Heart Surgery Rhomboid Intercostal Nerve Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Block group

Participants who will be receiving a rhomboid intercostal nerve block

Group Type EXPERIMENTAL

Rhomboid Intercostal Nerve Block

Intervention Type PROCEDURE

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.

Control group

Participant who will not be receiving any intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Koç University

OTHER

Sponsor Role lead

Responsible Party

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Kamil Darcin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kamil Darçın, MD

Role: STUDY_DIRECTOR

Koç University

Locations

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Koc University

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Kamil Darçın, MD

Role: CONTACT

+90 505 589 50 99

Yasemin Sincer, MD

Role: CONTACT

Facility Contacts

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Kamil Darçın

Role: primary

+905055895099

Yasemin Sincer

Role: backup

+90512040834

Other Identifiers

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2022.462.IRB1.182

Identifier Type: -

Identifier Source: org_study_id

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