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

NCT06926764 | Not Yet Recruiting

• 1 other identifier: ITBP - Acute pain
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.To investigate the efficacy of intertransverse process block (ITPB) on quality of recovery after cardiac surgery
2. 2.To investigate the efficacy of ITPB on the sympathetic response on incision, intraoperative and postoperative morphine requirement
3. 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

Keywords

Cardiac surgery; Intertransverse process block; ITPB; CABG; Quality of Recovery; Acute postoperative pain

Outcome Measures

Primary Outcomes (1)

• Quality of recovery at 24 hours after extubation

  Chinese validated version of the Quality of Recovery Questionnaire (QoR-15), range from 0 - 150, with 150 indicating excellent recovery and 0 indicated poor recovery.

  24 hours after extubation

Secondary Outcomes (15)

• Quality of recovery at 72 hours after extubation

  72 hours after extubation

• Intraoperative opioid consumption

  Intraoperatively

• Morphine consumption

  within 24 and 72 hours after surgery

• SBP change on incision for sternotomy

  within 10 minutes of skin incision of sternotomy

• Postoperative pain score

  15 minutes after tracheal extubation and at 2, 4, 6, 8, 12, 24, 48 and 72 hours post-extubation

Study Arms (2)

Interventional arm

EXPERIMENTAL

Intertransverse process block is performed on patients with injection of 25ml 0.25% levobupivacaine at the retro-SCTL space after a test bolus of 1-2ml 0.9% normal saline. The same procedure is repeated on the other side with same volume of study medication.

Procedure: Intertransverse process block; Drug: Levobupivacaine 0.25%; Device: Ultrasound guided injection with local anaestethic

Control arm

SHAM COMPARATOR

Sham intertransverse process block is performed on patients with injection of 25ml placebo at the retro-SCTL space after a test bolus of 1-2ml 0.9% normal saline. The same procedure is repeated on the other side with same volume of study medication.

Procedure: Sham Block; Drug: Sodium Chloride (NaCl) 0.9 %; Device: Ultrasound guided injection with local anaestethic

Interventions

Intertransverse process block PROCEDURE

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

Interventional arm

Sham Block PROCEDURE

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.

Control arm

Levobupivacaine 0.25% DRUG

Drug used for intertransverse process block (intervention group)

Interventional arm

Sodium Chloride (NaCl) 0.9 % DRUG

As placebo for sham block group

Control arm

Ultrasound guided injection with local anaestethic DEVICE

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

Control arm; Interventional arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 18 or older
• undergoing elective coronary artery bypass graft (CABG), valve repair/replacement, or combined CABG/valve procedure via sternotomy.

You may not qualify if:

• Emergency surgery
• redo surgery
• history of thoracotomy or mastectomy
• patients with history of chronic pain
• patients on chronic opioids or sedatives
• renal failure with estimated glomerular filtration rate \<30ml/min (calculated by Cockcroft-Gault formula)
• intraoperative use of remifentanil
• unable to provide informed consent.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

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MeSH Terms

Conditions

Pain, Postoperative

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Henry Wong

  Hospital Authority

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zion Yeung

CONTACT

+85295782790; yhosum928@gmail.com

Henry Wong

CONTACT

85297280005; mkw118@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anaesthesiologist

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 15, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share