Clinical trial NCT04838132: Transversus Thoracis Muscle Plane Block Plus Rectus Sheath Block in the Perioperative Pain Management of Cardiac Surgery
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Bypass Grafting or Heart Valve Surgery Via Median Sternotomy
Lead sponsor: Guangzhou First People's Hospital
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of hyperalgesia
timeFrame: Surgery to 48 hours after
measure: The total amount of analgesics used in the perioperative period.
timeFrame: Surgery to 48 hours after
Secondary outcomes:
measure: Visual Analogue Scale
timeFrame: Extubation to 24 hours after
measure: Length of stay in hospital
timeFrame: the day before hospital discharge
measure: Postoperative complications
timeFrame: the day before hospital discharge
measure: incidence of postoperative delirium
timeFrame: Day 7 after operation
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
Study officials:
affiliation: Guangzhou First People's Hospital
name: Bin Zheng, doctor
role: STUDY_CHAIR
References: