An interventional study of Rhomboid Intercostal Nerve Block in Minimal Invasive Heart Surgery and Rhomboid Intercostal Nerve Block, sponsored by Koç University. Recruiting at 1 site in Turkey. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-03-05.
Sponsored by Koç University · Not applicable, Interventional, and Other
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:
Participants will be divided in two groups:
The hypothesis of this study is that participants receiving RINB for MIHS will have a less total opioid consumption 24 hours postoperatively.
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.
Koç University is the lead sponsor of 106 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants who will be receiving a rhomboid intercostal nerve block
Procedure: Rhomboid Intercostal Nerve Block
Participant who will not be receiving any intervention
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.
Total opioid consumption
all consumed opioids will be converted in morphine equivalents and then added to reach the total dosage
Time frame: 24 hours post-surgery
Numeric rating scale scores for pain
the scale between 0: no pain and 10:highes pain answered by the participants
Time frame: 24 hours post-surgery
Extubation time after surgery
measured in hours
Time frame: 24 hours post-surgery
Length of intensive care unit stay
measured in hours
Time frame: 1 week follow up after surgery
Opioid related side effects
Nausea, vomiting, pruritis, respiratory depression assessed by yes/no questions
Time frame: 24 hours post surgery
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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Koç University