Clinical trial NCT05861804: Analgesic Efficacy of Rhomboid Intercostal Nerve Block for Minimal Invasive Heart Surgery
Official title: Analgesic Efficacy of Rhomboid Intercostal Nerve Block for Minimal Invasive Heart Surgery: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Minimal Invasive Heart Surgery
Rhomboid Intercostal Nerve Block
Keywords: rhomboid intercostal nerve block
minimal invasive heart surgery
cardiac anesthesia
Lead sponsor: Koç University
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Total opioid consumption
timeFrame: 24 hours post-surgery
Secondary outcomes:
measure: Numeric rating scale scores for pain
timeFrame: 24 hours post-surgery
measure: Extubation time after surgery
timeFrame: 24 hours post-surgery
measure: Length of intensive care unit stay
timeFrame: 1 week follow up after surgery
measure: Opioid related side effects
timeFrame: 24 hours post surgery
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Koc University
Study officials:
affiliation: Koç University
name: Kamil Darçın, MD
role: STUDY_DIRECTOR
References: