Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-30 @ 7:49 AM
Study NCT ID:
NCT05861804
Status:
RECRUITING
Last Update Posted:
2024-03-05
First Post:
2023-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesic Efficacy of Rhomboid Intercostal Nerve Block for Minimal Invasive Heart Surgery
Sponsor:
Koç University
Organization:
Study Overview
Official Title:
Analgesic Efficacy of Rhomboid Intercostal Nerve Block for Minimal Invasive Heart Surgery: A Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: