Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369870
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-08
Brief Title:
Interpectoral-pectoserratus Plane Block for Minimally Invasive Aortic Valve Replacement Via Right Anterior Minithoracotomy
Sponsor:
Algemeen Ziekenhuis Maria Middelares
Organization:
Algemeen Ziekenhuis Maria Middelares
Study Overview
Official Title:
Interpectoral-pectoserratus Plane Block for Minimally Invasive Aortic Valve Replacement Via Right Anterior Minithoracotomy a Single Centre Prospective Double-blind Randomized Controlled Superiority Trial
Status:
RECRUITING
Status Verified Date:
2024-09
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:
PAINCARE
Brief Summary:
The goal of this clinical trial is to evaluate the analgesic effect of locoregional anaesthesia specifically the interpectoral pectoserratus plane IPP-PSP block in comparison to a placebo sham block after Aortic Valve Replacement via Right Anterior Minithoracotomy AVR-RAT The main question the trial aims to answer is Can the IPP-PSP block effectively reduce opioid consumption within the first 48 hours after AVR-RAT surgery The purpose is to understand the impact of the IPP-PSP block on postoperative pain Therefore the aim is to investigate the influence of the IPP-PSP block on the amount of pain medication administered during the patients first 48 hours after surgery
Participants who are scheduled for AVR-RAT surgery will be randomly assigned to receive either the IPP-PSP block or the sham block Researchers will compare opioid consumption among other outcomes including differences in pain scores incidence of nausea and vomiting quality of recovery quality of life and the length of hospital stay between the two groups
Patients will be monitored during their hospitalization and a follow-up phone call will be conducted 30 days after surgery
Participants who are scheduled for AVR-RAT surgery will be randomly assigned to receive either the IPP-PSP block or the sham block Researchers will compare opioid consumption among other outcomes including differences in pain scores incidence of nausea and vomiting quality of recovery quality of life and the length of hospital stay between the two groups
Patients will be monitored during their hospitalization and a follow-up phone call will be conducted 30 days after surgery
Detailed Description:
This clinical trial aims to evaluate the analgesic effect of an interpectoral-pectoserratus plane IPP-PSP block compared to a placebo sham block in patients undergoing aortic valve replacement via right anterior minithoracotomy AVR-RAT The primary objective is to determine whether the IPP-PSP block effectively reduces opioid consumption during the first 28 hours post-surgery
The trial is designed as a single-center prospective double-blind randomized controlled superiority trial It will enroll adult patients aged 18 years or older who are scheduled for minimally invasive AVR-RAT and meet specific inclusion criteria Exclusion criteria are established to ensure the safety and integrity of the trial
Patients undergoing minimally invasive AVR-RAT will be randomly assigned to either the IPP-PSP block group or the sham block group
The primary endpoint of the trial is the cumulative opioid consumption in oral morphine milligram equivalents OMEs within the first 48 postoperative hours after completion of the surgical procedure Secondary outcomes include the number of episodes of postoperative pain time to need for rescue medication incidence of respiratory complications PaCO2 levels postsurgical recovery episodes of postoperative nausea and vomiting time to extubation in the Intensive Care Unit ICU ICU length of stay hospital length of stay quality of life number of days alive and at home after surgery and vital status at 30 days post-operative
The trial aims to enroll a total of 144 patients with 72 patients randomized into each group Blinding will be implemented meaning neither the participant anesthesiologist study nurse surgeon nor the doctors and nurses in the Intensive Care Unit will know the participants group assignment
The anesthesia and monitoring proceed as usual for such procedures After the anesthesiologist administered the IPP-PSP block or a placebo at the end of the procedure the participant will be transferred to the ICU During the hospital stay they will be regularly asked to assess their pain level and additional pain relief will be administered if necessary
To assess quality of recovery and quality of life differences between groups participants will complete two questionnaires the day before surgery A recovery questionnaire will be completed at three time points post-surgery day 1 day 2 and day 7 after the surgery Participants will be involved in the trial for a total of 31 days with follow-up during hospitalization and a follow-up phone call 30 days post-surgery
The trial is designed as a single-center prospective double-blind randomized controlled superiority trial It will enroll adult patients aged 18 years or older who are scheduled for minimally invasive AVR-RAT and meet specific inclusion criteria Exclusion criteria are established to ensure the safety and integrity of the trial
Patients undergoing minimally invasive AVR-RAT will be randomly assigned to either the IPP-PSP block group or the sham block group
The primary endpoint of the trial is the cumulative opioid consumption in oral morphine milligram equivalents OMEs within the first 48 postoperative hours after completion of the surgical procedure Secondary outcomes include the number of episodes of postoperative pain time to need for rescue medication incidence of respiratory complications PaCO2 levels postsurgical recovery episodes of postoperative nausea and vomiting time to extubation in the Intensive Care Unit ICU ICU length of stay hospital length of stay quality of life number of days alive and at home after surgery and vital status at 30 days post-operative
The trial aims to enroll a total of 144 patients with 72 patients randomized into each group Blinding will be implemented meaning neither the participant anesthesiologist study nurse surgeon nor the doctors and nurses in the Intensive Care Unit will know the participants group assignment
The anesthesia and monitoring proceed as usual for such procedures After the anesthesiologist administered the IPP-PSP block or a placebo at the end of the procedure the participant will be transferred to the ICU During the hospital stay they will be regularly asked to assess their pain level and additional pain relief will be administered if necessary
To assess quality of recovery and quality of life differences between groups participants will complete two questionnaires the day before surgery A recovery questionnaire will be completed at three time points post-surgery day 1 day 2 and day 7 after the surgery Participants will be involved in the trial for a total of 31 days with follow-up during hospitalization and a follow-up phone call 30 days post-surgery
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