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

Sponsor

Koç University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05861804

Collaborator

(none)

Enrollment

Location

Arms

7.5

Anticipated Duration (Months)

10.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Minimal Invasive Heart Surgery Rhomboid Intercostal Nerve Block	Procedure: Rhomboid Intercostal Nerve Block	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

78 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

May 15, 2023

Anticipated Primary Completion Date :

Dec 30, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Total opioid consumption [24 hours post-surgery]
all consumed opioids will be converted in morphine equivalents and then added to reach the total dosage

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Koc University	İstanbul		Turkey	34010

Sponsors and Collaborators

Koç University

Investigators

Study Director: Kamil Darçın, MD, Koç University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kamil Darcin, Principal Investigator, Koç University

ClinicalTrials.gov Identifier:

NCT05861804

Other Study ID Numbers:

2022.462.IRB1.182

First Posted:

May 17, 2023

Last Update Posted:

May 23, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Kamil Darcin, Principal Investigator, Koç University

rhomboid intercostal nerve block

minimal invasive heart surgery

cardiac anesthesia

Study Results

No Results Posted as of May 23, 2023