Coronary Artery Bypass Grafting or Heart Valve Surgery Via Median Sternotomy
Conditions
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.
Interventions
PROCEDUREBilateral transversus thoracis muscle plane and rectus sheath block with ropivacaine
A linear array transducer (6-13 MHz) with a sterile cover and a 22-gauge (G) block needle (KDL™, Kindly group, Shanghai, China) will be used. Place the ultrasound probe on the longitudinal plane 1 cm outside the edge of the sternum in the fourth intercostal space, and identify the T3-T4 intercostal space under ultrasound. Use the plane technique to place a 22-gauge, 80-mm needle obliquely upwards until the needle tip is located at the plane between the internal intercostal muscles and the transverse pectoralis muscle. After general anesthesia, all subjects were injected with 0.3% ropivacaine 15ml and 10ml respectively after insertion of a needle into bilateral transverse thoracic muscle plane and rectus sheath guided by B-ultrasound.
PROCEDUREBilateral transversus thoracis muscle plane and rectus sheath puncture with saline
A linear array transducer (6-13 MHz) with a sterile cover and a 22-gauge (G) block needle (KDL™, Kindly group, Shanghai, China) will be used. Place the ultrasound probe on the longitudinal plane 1 cm outside the edge of the sternum in the fourth intercostal space, and identify the T3-T4 intercostal space under ultrasound. Use the plane technique to place a 22-gauge, 80-mm needle obliquely upwards until the needle tip is located at the plane between the internal intercostal muscles and the transverse pectoralis muscle. After general anesthesia, all subjects were injected with 0.9% saline 15ml and 10ml respectively after insertion of a needle into bilateral transverse thoracic muscle plane and rectus sheath guided by B-ultrasound.
Sponsors
Guangzhou First People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients voluntarily cooperate with the study and sign an informed consent form; * Ages between 18 and 65; * American Society of Anesthesiologists (ASA) classification: I-III; * Undergo coronary artery bypass grafting (CABG) or heart valve surgery with midsternal incision.
Exclusion criteria
* Refuse to participate in the trial; * Allergic to the anesthetics or analgesics; * Suffering with serious systemic diseases (kidney, liver, lungs and endocrine system); * American Association of Anesthesiologists (ASA) classification: IV-V; * Unstable hemodynamics; * History of drug abuse or chronic pain; * Mental disorders or communication difficulties; * Died during or immediately after the operation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hyperalgesia | Surgery to 48 hours after | a 180mN von-Frey wire (Touch Test™ Sensory Evaluator, USA) was used to test the pain sensitivity of the area around the wound |
| The total amount of analgesics used in the perioperative period. | Surgery to 48 hours after | During the perioperation, the amount of analgesics during the operation, the total amount of analgesic pump drugs used and the frequency of pressing the additional bolus trigger in the patient's analgesia system at 48 hours after the operation, and the amount of remedial analgesics |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale | Extubation to 24 hours after | A scale with a length of about 10cm is used. One side is marked with 10 scales, and the two ends are marked with 0 and 10 points respectively. 0 points mean painless, and 10 points mean the most intense pain that is unbearable |
| Length of stay in hospital | the day before hospital discharge | record how many days doses the patient spends in hospital |
| Postoperative complications | the day before hospital discharge | such as nausea and vomiting, pulmonary infection, wound infection, delayed healing, renal insufficiency, etc. |
| incidence of postoperative delirium | Day 7 after operation | Changes in postoperative state of consciousness were assessed |
Countries
China
Contacts
Primary ContactJierong Luo, master
Backup ContactBin Zheng, doctor
Outcome results
None listed