Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06418100
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-02-26
Brief Title:
Recto-intercostal Block for Coronary Artery Bypass Grafting
Sponsor:
Haseki Training and Research Hospital
Organization:
Haseki Training and Research Hospital
Study Overview
Official Title:
Recto-intercostal Fascial Plane Block for Postoperative Analgesia in Coronary Artery Bypass Grafting With Sternotomy a Randomized Double-blind Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-02
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:
This interventional study aims to learn about the postoperative analgesic efficacy of a new fascial plane block recto-intercostal fascial plane block at coronary artery bypass grafting with sternotomy There will be two groups one of which will be the control group and the other will be the study group randomly receiving postoperative recto-intercostal fascial plane block
The main questions it aims to answer are the effect of this new block on postoperative opioid consumption and pain scores Also postoperative outcomes related to respiratory postoperative oxygenation and atelectasis score hemodynamic functions newly developed arrhythmias total postanesthesia care unit stay and hospital stay will be questioned
The main questions it aims to answer are the effect of this new block on postoperative opioid consumption and pain scores Also postoperative outcomes related to respiratory postoperative oxygenation and atelectasis score hemodynamic functions newly developed arrhythmias total postanesthesia care unit stay and hospital stay will be questioned
Detailed Description:
All patients will receive standard general anaesthesia under standard monitoring along with the bispectral index Medtronic Intubation will be performed by administering intravenous IV 003 mgkg midazolam propofol Lipuro Braun max 2 mgkg according to BIS two mcgkg fentanyl Talinat VEM 1 mg kg rocuronium Esmeron Alessandroorsini followed by 1 MAC sevoflurane Sevorane Abbott in an air-oxygen mixture for maintenance of anaesthesia Following anaesthesia induction all participants will receive superficial parasternal intercostal plane block SPIP bilaterally along with 8 mg dexamethasone before surgical incision as part of multimodal analgesia by a single experienced regional anaesthesiologist BC under ultrasound guidance Esaote MyLab Seven SPIPB will be performed using a high-frequency probe to visualize the pectointercostal fascial area at the intercostal level of the intercostal 3-4 level and 20 ml 025 bupivacaine was injected bilaterally After applying SPIPB the surgery is set to begin after at least 15 minutes of block procedure The intraoperative analgesic need will be supplied by fentanyl bolus doses as 50 mcq if necessary as heart rate or systolic blood pressure increases by more than 15 According to randomization the intervention group will receive RIFPB with 20 ml 025 bupivacaine
From the beginning of acclaimed arousal till the 24th hour rescue analgesia as tramadol 100 mg maximum daily dose 400 mg is applied if NRS is over four or with the patients request The routine analgesia regimen was 1 gram IV paracetamol 6th hourly postoperatively at the PACU All patients were followed up from the extubation time till hospital discharge to evaluate respiratory and hemodynamic changes possible complications and total postoperative time
From the beginning of acclaimed arousal till the 24th hour rescue analgesia as tramadol 100 mg maximum daily dose 400 mg is applied if NRS is over four or with the patients request The routine analgesia regimen was 1 gram IV paracetamol 6th hourly postoperatively at the PACU All patients were followed up from the extubation time till hospital discharge to evaluate respiratory and hemodynamic changes possible complications and total postoperative time
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None