Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2026-01-02 @ 11:40 AM
Study NCT ID:
NCT04838132
Status:
UNKNOWN
Last Update Posted:
2021-04-08
First Post:
2021-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transversus Thoracis Muscle Plane Block Plus Rectus Sheath Block in the Perioperative Pain Management of Cardiac Surgery
Sponsor:
Guangzhou First People's Hospital
Organization:
Study Overview
Official Title:
Application of Transversus Thoracis Muscle Plane Block Plus Rectus Sheath Block in the Perioperative Pain Management of Cardiac Surgery : Study Protocol of a Randomized Double-blind Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
RECRUITING
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:
An emerging regional block technique, transverse thoracic muscle block covers the T2-T6 intercostal nerves and can effectively relieve perioperative pain during median sternotomy. Bilateral transverse thoracic muscle plane( TTP) block is expected to be a new analgesic mode in perioperative of cardiac surgery via sternotomy.
Detailed Description:
This is a single-center, randomized, double-blind, parallel controlled clinical trial. Eighty patients planning to undergo coronary artery bypass grafting or heart valve surgery via median sternotomy were randomly assigned 1:1 to the experimental group or control group. After general anesthesia, all subjects were injected with 0.3% ropivacaine (experimental group) or 0.9% normal saline (control group) 15ml and 10ml respectively after insertion of a needle into bilateral transverse thoracic muscle plane and rectus sheath guided by B-ultrasound by anesthesiologist. The main outcome indicators were the threshold of incision pain and the total amount of analgesics used during the operation and 48h after the operation. Secondary outcome measures were as follows: postoperative VAS score, duration of mechanical ventilation, days in ICU, total days of hospitalization, and hospitalization cost. This study will provide evidence-based medical evidence and clinical data support for the application of TTP block in cardiac 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?:
False
Is an FDA AA801 Violation?: