Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT05999721
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2023-08-06
Brief Title:
The Effect of Superficial Parasternal Intercostal Plane Block on Pulmonary Function Tests After Cardiac Surgery
Sponsor:
Shai Fein
Organization:
Rabin Medical Center
Study Overview
Official Title:
The Effect of Superficial Parasternal Intercostal Plane Block on Pulmonary Function Tests After Cardiac Surgery PIPACS Trial a Prospective Double-blind Randomised Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
PIPACS
Brief Summary:
In adult patients undergoing cardiac surgery does adding an sPIP block to standard care compared to standard care alone result in a smaller decrease in PFTs
Detailed Description:
Postoperative pulmonary complications pose a significant concern after cardiac surgery Post-sternotomy pain plays a key role in impaired pulmonary function tests ultimately increasing the risk of postoperative pulmonary complications Parasternal intercostal plane blocks have recently emerged as a promising analgesic modality for cardiac surgery However the impact of parasternal intercostal plane blocks on pulmonary function tests remains unexplored
In this prospective single-centre double-blind randomised controlled trial a total of 100 participants undergoing elective cardiac surgery will be recruited Prior to surgery baseline pulmonary function tests will be measured Throughout the surgical procedure all participants will receive identical anaesthesia and surgical protocols At the end of the surgery and after sternal wound closure participants will be randomly assigned to one of two research arms in a 11 ratio The treatment arm will receive a superficial parasternal intercostal plane block in addition to standard care while the control arm will receive standard care alone Pulmonary function tests pain scores and opioid consumption will be recorded daily until the third postoperative day The primary outcome is the difference between pre and postoperative PFTs values Secondary outcomes are pain scores opioid consumption the incidence of postoperative pulmonary complications during current hospitalisation cardiothoracic intensive care unit hospital length stay and 30-day mortality
Pulmonary function tests were selected as the primary outcome due to their practicality and relevance to the postoperative course The superficial parasternal intercostal plane block was chosen as the study intervention due to its simplicity and feasibility The hypothesis posits that the addition of this intervention to standard care compared to standard care alone results in a smaller decrease in pulmonary function tests
In this prospective single-centre double-blind randomised controlled trial a total of 100 participants undergoing elective cardiac surgery will be recruited Prior to surgery baseline pulmonary function tests will be measured Throughout the surgical procedure all participants will receive identical anaesthesia and surgical protocols At the end of the surgery and after sternal wound closure participants will be randomly assigned to one of two research arms in a 11 ratio The treatment arm will receive a superficial parasternal intercostal plane block in addition to standard care while the control arm will receive standard care alone Pulmonary function tests pain scores and opioid consumption will be recorded daily until the third postoperative day The primary outcome is the difference between pre and postoperative PFTs values Secondary outcomes are pain scores opioid consumption the incidence of postoperative pulmonary complications during current hospitalisation cardiothoracic intensive care unit hospital length stay and 30-day mortality
Pulmonary function tests were selected as the primary outcome due to their practicality and relevance to the postoperative course The superficial parasternal intercostal plane block was chosen as the study intervention due to its simplicity and feasibility The hypothesis posits that the addition of this intervention to standard care compared to standard care alone results in a smaller decrease in pulmonary function tests
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