Transversus Thoracis Muscle Plane Block Plus Rectus Sheath Block in the Perioperative Pain Management of Cardiac Surgery

Not Applicable

• Conditions: Coronary Artery Bypass Grafting or Heart Valve Surgery Via Median Sternotomy

• Registration Number: NCT04838132
• Lead Sponsor: Guangzhou First People's Hospital

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 Timeline

• Status Verified: 2021-03
• Study Start: 2021-03-16
• Study First Submitted: 2021-03-30
• Study First Submitted QC: 2021-04-06
• Last Update Submitted: 2021-04-06
• Study First Posted: 2021-04-08
• Last Update Posted: 2021-04-08
• Primary Completion: 2021-10-31
• Study Completion: 2021-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Length of stay in hospital	the day before hospital discharge	record how many days doses the patient spends in hospital
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
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

Trial Locations

Locations (1)

Guangzhou First People's Hospital; 🇨🇳 Guangzhou, Guangdong, China