Intertransverse Process Block to Improve Quality of Recovery After Cardiac Surgery With Sternotomy

Summary

The goal of this clinical trial is to evaluate the efficacy of intertransverse process block (ITPB) in blunting sympathetic response of sternotomy, achieving perioperative opioid-sparing and improving quality of recovery in adult patients undergoing elective cardiac surgery (e.g., coronary artery bypass graft \[CABG\], valve repair/replacement, or combined CABG/valve procedures).

The main questions it aims to answer are:

1. To investigate the efficacy of intertransverse process block (ITPB) on quality of recovery after cardiac surgery
2. To investigate the efficacy of ITPB on the sympathetic response on incision, intraoperative and postoperative morphine requirement
3. To investigate the efficacy of ITPB on surgical outcomes including time to weaning off mechanical ventilation, length of ICU/ hospital stay and incidence of neuropathic pain after surgery Researchers will compare patients receiving bilateral ITPB with levobupivacaine to those receiving sham blocks to determine if ITPB reduces CPSP, improves pain control, and decreases opioid consumption.

Conditions

• Acute Postoperative Pain

Interventions

PROCEDURE

Intertransverse process block

All blocks are performed by an anaesthesiologist who had previously performed ≥50 successful ITPB blocks, using Philips EPIQ ultrasound system, with a curved array transducer (C5-1), and 80mm echogenic nerve block needle. ITPB is performed with the patients positioned in a lateral decubitus position. The target intervertebral level (T4-5) is identified and marked in the preview ultrasound scan. The transducer is placed 2-3 cm lateral to the spinous process. Under strict asepsis, a single-level (T4-5) ultrasound-guided ITPB is performed with the in-plane insertion of the block needle from lateral to medial direction until its tip is at the medial aspect of the retro-SCTL space. After confirming the needle position by distension of the retro-SCTL space after a test bolus injection of 1-2 ml 0.9% normal saline, 25 ml 0.25% levobupivacaine is injected via the nerve block needle in small aliquots. The same procedure is repeated on the other side with the same v

PROCEDURE

Sham Block

All blocks are performed by an anaesthesiologist who had previously performed ≥50 successful ITPB blocks, using Philips EPIQ ultrasound system, with a curved array transducer (C5-1), and 80mm echogenic nerve block needle (SonoTAP; PAJUNK, Germany). ITPB is performed with the patients positioned in a lateral decubitus position. The target intervertebral level (T4-5) is identified and marked in the preview ultrasound scan. The transducer is placed 2-3 cm lateral to the spinous process. Under strict asepsis, a single-level (T4-5) ultrasound-guided ITPB is performed with the in-plane insertion of the block needle from lateral to medial direction until its tip is at the medial aspect of the retro-SCTL space. After confirming the needle position by distension of the retro-SCTL space after a test bolus injection of 1-2 ml 0.9% normal saline, 25 ml placebo is injected via the nerve block needle in small aliquots. The same procedure is repeated on the other side with the same volume study drug.

DRUG

Levobupivacaine 0.25%

Drug used for intertransverse process block (intervention group)

DRUG

Sodium Chloride (NaCl) 0.9 %

As placebo for sham block group

DEVICE

Ultrasound guided injection with local anaestethic

Philips EPIQ ultrasound system, with a curved array transducer (C5-1), and 80mm echogenic nerve block needle (SonoTAP; PAJUNK, Germany)

Sponsors & Collaborators

• Chinese University of Hong Kong

  lead OTHER

Principal Investigators

• Henry Wong · Hospital Authority

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-30

Primary Completion

2027-11-30

Completion

2027-11-30