Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06239025
Status:
RECRUITING
Last Update Posted:
2024-02-13
First Post:
2024-01-25
Brief Title:
Efficacy of Transversus Thoracis Muscle Plane Block in Patients Undergoing Cardiac Surgery
Sponsor:
Hôpital du Valais
Organization:
Hôpital du Valais
Study Overview
Official Title:
Efficacy of Transversus Thoracis Muscle Plane Block in Patients Undergoing Cardiac Surgery A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
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:
TTMP_Block
Brief Summary:
The goal of this randomized double blind study is to evaluate the analgesic efficacy of Transversus Thoracis Muscle Plane Block in patients undergoing cardiac surgery with median sternotomy
one group of participants will receive multimodal analgesia plus ultrasound-guided Transversus Thoracis Muscle Plane Block with ropivacaine 05 after induction of general anesthesia the other group will receive multimodal analgesia without a bloc
The investigators want to know if participants who receive the Transversus Thoracis Muscle Plane Block with ropivacaine have less pain than participants who do not receive a block
one group of participants will receive multimodal analgesia plus ultrasound-guided Transversus Thoracis Muscle Plane Block with ropivacaine 05 after induction of general anesthesia the other group will receive multimodal analgesia without a bloc
The investigators want to know if participants who receive the Transversus Thoracis Muscle Plane Block with ropivacaine have less pain than participants who do not receive a block
Detailed Description:
Participants who undergo elective cardiac surgery with median sternotomy are eligible They will receive general anaesthesia with multimodal analgesia as is standard in our institution For study purposes participants will be randomized in a double blinded fashion to receive a Transversus Thoracis Muscle Plane Block with 30 mL of ropivacaine 05 or no block As the block is carried out after induction of general anesthesia the participants will not know to which group they are assigned
all blocks will be carried out after induction of general anesthesia under full sterile precautions and with ultrasound guidance multimodal analgesia intra- and postoperatively is standardized and consists of sufentanil ketamine dexmedetomidine dexamethasone paracetamol metamizole IV morphine in ICU
The investigators aim for fast track surgery ie extubation either in the operating room or in ICU within the first 6 postoperative hours
the primary outcome is postoperative opioid consumption over the first 24 h postoperatively secondary outcomes are pain scores and opioid-related side effects all outcomes will be assessed by blinded investigators
all blocks will be carried out after induction of general anesthesia under full sterile precautions and with ultrasound guidance multimodal analgesia intra- and postoperatively is standardized and consists of sufentanil ketamine dexmedetomidine dexamethasone paracetamol metamizole IV morphine in ICU
The investigators aim for fast track surgery ie extubation either in the operating room or in ICU within the first 6 postoperative hours
the primary outcome is postoperative opioid consumption over the first 24 h postoperatively secondary outcomes are pain scores and opioid-related side effects all outcomes will be assessed by blinded investigators
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