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

K

Koç University

Status

Enrolling

Conditions

Rhomboid Intercostal Nerve Block
Minimal Invasive Heart Surgery

Treatments

Procedure: Rhomboid Intercostal Nerve Block

Study type

Interventional

Funder types

Other

Identifiers

NCT05861804
2022.462.IRB1.182

Details and patient eligibility

About

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.

Full 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.

Enrollment

78 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

78 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Yasemin Sincer, MD; Kamil Darçın, MD

Data sourced from clinicaltrials.gov

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