Analgesic Efficacy of Rhomboid Intercostal Nerve Block fo... | NCT05861804

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

NCT05861804

Sponsor

Koç University

Status

Unknown status

Last Update Posted

Mar 5, 2024Actual

Enrollment

78Estimated

Phase

Not Applicable

Conditions

Minimal Invasive Heart Surgery
Rhomboid Intercostal Nerve Block

Interventions

Rhomboid Intercostal Nerve Block

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2023Actual

Primary Completion Date

Dec 30, 2024Estimated

Completion Date

Dec 30, 2024Estimated

First Submitted Date

May 7, 2023

First Submission Date that Met QC Criteria

May 7, 2023

First Posted Date

May 17, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2024

Last Update Posted Date

Mar 5, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

78Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Block group	Experimental	Participants who will be receiving a rhomboid intercostal nerve block	Procedure: Rhomboid Intercostal Nerve Block
Control group	No Intervention	Participant who will not be receiving any intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rhomboid Intercostal Nerve Block	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.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kamil Darçın, MD	Contact	+90 505 589 50 99		kdarcin@ku.edu.tr
Yasemin Sincer, MD	Contact			sincer.yasemin@gmail.com

Overall Officials

Name	Affiliation	Role
Kamil Darçın, MD	Koç University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Koc University	Recruiting	Istanbul		34010	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Time Frame

Starting from 6 months after publication for 5 years

Access Criteria

no access criteria

URL

Not provided