Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06205875
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-01-04
Brief Title:
High Versus Low Dose Serratus Anterior Plane Block After Minimally Invasive Valve Surgery
Sponsor:
Jessa Hospital
Organization:
Jessa Hospital
Study Overview
Official Title:
High Versus Low Dose Serratus Anterior Plane Block After Minimally Invasive Valve Surgery a Double-blinded Randomized Controlled 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:
This study aims to compare the efficacy and quality of pain relief provided by the high-dose serratus anterior plane SAP block with the standard SAP block in preventing and treating acute postoperative pain after total endoscopic aortic or mitral valve surgery
Detailed Description:
During the last two decades cardiac surgical techniques have changed dramatically Evidence for good short and long-term outcomes after endovascular and minimally invasive procedures is rising This shift made it possible to avoid sternotomy and thus facilitating earlier patient recovery without compromising safety Therefore enhanced recovery after surgery ERAS protocols have been implemented to aim for early extubation and ambulation While policies for early extubation and discharge from the hospital have been implemented the analgesic regimen has not been modified Opioids remain the standard treatment in the postoperative setting after cardiac surgery despite known side effects such as nausea constipation and the risk of addiction Neuraxial anaesthesia techniques which require fewer opioids in cardiac surgery have been studied and validated but not yet implemented
In 2013 the serratus anterior plane SAP block was described as a pain relief option for chest surgery This anaesthesia technique injects local anaesthetics under the serratus muscle and between the latissimus dorsi and serratus anterior using ultrasound Successful pain relief with this SAP block has been reported in thoracotomy chest surgery and rib fractures In our previous study we demonstrated a 40 reduction in morphine consumption during the first 24 hours after total endoscopic aortic valve replacement with an SAP block compared to a control group without an SAP block Lower pain scores were also observed in the SAP group
As such in this proposed study we aim to optimise the intensity of the Serratus anterior plane block SAPB to decrease opioid requirements further and to encounter more favourable secondary clinical outcome parameters One strategy to increase the duration of action of plane blocks is injecting higher doses of local anaesthetics A meta-analysis by De Oliveira et al on transabdominal plane TAP-blocks for abdominal surgery showed a correlation between the local anaesthetic dose and the late block effect impacting both pain scores and opioid consumption In a randomised controlled trial by Suresh a TAP block with bupivacaine 125 mcgkg was compared to a TAP block with bupivacaine 25 mcgkg revealing a longer duration of analgesia and a lower need for additional analgesics up to 24 hours post-surgery Moreover loading doses up to 2mgkg body weight are recommended for truncal blocks in general but the mean injected dose in our intervention group was 125mgkg considering a mean patient body weight of 792kg Notably a pharmacokinetic study by Maximos and colleagues on an adrenalised bupivacaine mixture after pectointercostal fascial plane block PIFB after cardiac surgery showed that despite injecting 2mcgkg adrenalised bupivacain both total and free arterial serum bupivacaine levels were 10-20 times lower than levels associated with neurologic or cardiovascular toxicity in the literature
In conclusion we are convinced we can safely improve the late effects of our SAPB compared to our first study by increasing the dose of the local anesthetic injectate
In 2013 the serratus anterior plane SAP block was described as a pain relief option for chest surgery This anaesthesia technique injects local anaesthetics under the serratus muscle and between the latissimus dorsi and serratus anterior using ultrasound Successful pain relief with this SAP block has been reported in thoracotomy chest surgery and rib fractures In our previous study we demonstrated a 40 reduction in morphine consumption during the first 24 hours after total endoscopic aortic valve replacement with an SAP block compared to a control group without an SAP block Lower pain scores were also observed in the SAP group
As such in this proposed study we aim to optimise the intensity of the Serratus anterior plane block SAPB to decrease opioid requirements further and to encounter more favourable secondary clinical outcome parameters One strategy to increase the duration of action of plane blocks is injecting higher doses of local anaesthetics A meta-analysis by De Oliveira et al on transabdominal plane TAP-blocks for abdominal surgery showed a correlation between the local anaesthetic dose and the late block effect impacting both pain scores and opioid consumption In a randomised controlled trial by Suresh a TAP block with bupivacaine 125 mcgkg was compared to a TAP block with bupivacaine 25 mcgkg revealing a longer duration of analgesia and a lower need for additional analgesics up to 24 hours post-surgery Moreover loading doses up to 2mgkg body weight are recommended for truncal blocks in general but the mean injected dose in our intervention group was 125mgkg considering a mean patient body weight of 792kg Notably a pharmacokinetic study by Maximos and colleagues on an adrenalised bupivacaine mixture after pectointercostal fascial plane block PIFB after cardiac surgery showed that despite injecting 2mcgkg adrenalised bupivacain both total and free arterial serum bupivacaine levels were 10-20 times lower than levels associated with neurologic or cardiovascular toxicity in the literature
In conclusion we are convinced we can safely improve the late effects of our SAPB compared to our first study by increasing the dose of the local anesthetic injectate
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