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

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Bypass Grafting or Heart Valve Surgery Via Median Sternotomy
• Intervention / Treatment: Procedure: Bilateral transversus thoracis muscle plane and rectus sheath block with ropivacaine; Procedure: Bilateral transversus thoracis muscle plane and rectus sheath puncture with saline

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510180
      • Recruiting
      • Guangzhou First People's Hospital
      • Contact: Jierong Luo, MD; Phone Number: 86-20-81048306; Email: jierongluo@outlook.com
      • Sub-Investigator: Jierong Luo, MD
      • Principal Investigator: Bin Zheng, MD
      • Sub-Investigator: Guokun Ou, MD
      • Sub-Investigator: Haitao Zhou, MD
      • Sub-Investigator: Xiaoqing Xie, MD, Msc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transversus thoracis muscle plane and rectus sheath block with ropivacaine; Using 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 (TTP block) and rectus sheath block, give 15ml and 10ml 0.3% ropivacaine respectively.	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.
Experimental: Transversus thoracis muscle plane and rectus sheath puncture with saline; Using 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 (TTP block) and rectus sheath block, give 15ml and 10ml 0.9% saline respectively.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Length of stay in hospital	record how many days doses the patient spends in hospital	the day before hospital discharge
Postoperative complications	such as nausea and vomiting, pulmonary infection, wound infection, delayed healing, renal insufficiency, etc.	the day before hospital discharge
incidence of postoperative delirium	Changes in postoperative state of consciousness were assessed	Day 7 after operation

Collaborators and Investigators

• Sponsor: Guangzhou First People's Hospital
• Investigators: Study Chair: Bin Zheng, doctor, Guangzhou First People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2021
• Primary Completion (Anticipated): October 31, 2021
• Study Completion (Anticipated): November 30, 2021

Study Registration Dates

• First Submitted: March 30, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: K-2021-009-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No