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

G

Guangzhou First People's Hospital

Status

Unknown

Conditions

Coronary Artery Bypass Grafting or Heart Valve Surgery Via Median Sternotomy

Treatments

Procedure: Bilateral transversus thoracis muscle plane and rectus sheath block with ropivacaine
Procedure: Bilateral transversus thoracis muscle plane and rectus sheath puncture with saline

Study type

Interventional

Funder types

Other

Identifiers

NCT04838132
K-2021-009-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

80 participants in 2 patient groups

Transversus thoracis muscle plane and rectus sheath block with ropivacaine
Experimental group
Description:
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.
Treatment:
Procedure: Bilateral transversus thoracis muscle plane and rectus sheath block with ropivacaine
Transversus thoracis muscle plane and rectus sheath puncture with saline
Experimental group
Description:
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.
Treatment:
Procedure: Bilateral transversus thoracis muscle plane and rectus sheath puncture with saline

Trial contacts and locations

1

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Central trial contact

Jierong Luo, master; Bin Zheng, doctor

Data sourced from clinicaltrials.gov

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