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

Coronary Artery Bypass Grafting or Heart Valve Surgery Via Median Sternotomy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04838132
• Other study ID #: K-2021-009-01
• Status: Recruiting
• Phase: N/A
• Start date: March 16, 2021
• Est. completion date: November 30, 2021

Study information

• Verified date: March 2021
• Source: Guangzhou First People's Hospital
• Contact: Jierong Luo, master
• Phone: +8615802031110
• Email: jierongluo[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 30, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Bilateral 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.
• Bilateral 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.

Locations

Country	Name	City	State
China	Guangzhou First People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou First People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hyperalgesia	a 180mN von-Frey wire (Touch Test™ Sensory Evaluator, USA) was used to test the pain sensitivity of the area around the wound	Surgery to 48 hours after
Primary	The total amount of analgesics used in the perioperative period.	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	Surgery to 48 hours after
Secondary	Visual Analogue Scale	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	Extubation to 24 hours after
Secondary	Length of stay in hospital	record how many days doses the patient spends in hospital	the day before hospital discharge
Secondary	Postoperative complications	such as nausea and vomiting, pulmonary infection, wound infection, delayed healing, renal insufficiency, etc.	the day before hospital discharge
Secondary	incidence of postoperative delirium	Changes in postoperative state of consciousness were assessed	Day 7 after operation