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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05861804
Enrollment
78
Registered
2023-05-17
Start date
2023-06-01
Completion date
2024-12-30
Last updated
2024-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Minimal Invasive Heart Surgery, Rhomboid Intercostal Nerve Block

Keywords

rhomboid intercostal nerve block, minimal invasive heart surgery, cardiac anesthesia

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.

Interventions

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.

Sponsors

Koç University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Total opioid consumption24 hours post-surgeryall consumed opioids will be converted in morphine equivalents and then added to reach the total dosage

Secondary

MeasureTime frameDescription
Numeric rating scale scores for pain24 hours post-surgerythe scale between 0: no pain and 10:highes pain answered by the participants
Extubation time after surgery24 hours post-surgerymeasured in hours
Length of intensive care unit stay1 week follow up after surgerymeasured in hours
Opioid related side effects24 hours post surgeryNausea, vomiting, pruritis, respiratory depression assessed by yes/no questions

Countries

Turkey (Türkiye)

Contacts

Primary ContactKamil Darçın, MD
kdarcin@ku.edu.tr+90 505 589 50 99
Backup ContactYasemin Sincer, MD
sincer.yasemin@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026