Intertransverse Process Block to Improve Quality of Recovery and Pain Management in Adult Cardiac Surgical Patients

NCT06946290 | Recruiting DMC

• 1 other identifier: ITPB - chronic pain
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the efficacy of intertransverse process block (ITPB) in improving quality of recovery and potentially preventing chronic postsurgical pain (CPSP) 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 quality of recovery after cardiac surgery, and its analgesic efficacy in the immediate postoperative period
2. 2.To investigate the efficacy of intertransverse process block (ITPB) on CPSP after cardiac surgery by determining the incidence of CPSP at 3 month, defined as persistent pain that was not present before surgery or that had different characteristics, and other possible causes of pain are excluded.
3. 3.To investigate the efficacy of ITPB on the incidence of CPSP at 6 month, 12 month, and the pain interference (sensory and affective components, physical activities) at 3 month, 6 month and 12 month after surgery

Conditions

Chronic Postsurgical Pain

Keywords

ITPB; Intertransverse process block; Chronic postsurgical pain; Cardiac surgery; quality of recovery

Outcome Measures

Primary Outcomes (1)

• Quality of recovery at 24 hours after extubation

  The score ranges from 0 to 150, with higher scores associated with better quality of recovery. Though acute pain is identified as an important predictor for the development of CPSP, advanced pain management strategies have failed to reduce the overall incidence of CPSP, suggesting a complex underlying mechanism. Evidence have demonstrated that pain-related functional interference and patient-reported outcomes, such as quality of recovery, might be associated with the development of CPSP. Thus, the primary outcome of this study is the Quality of Recovery (QoR-15) score at 24 hours after extubation. QoR is recommended for patient's comfort after surgery, and is highly valid and reliable patient-centred outcome measure.

  24 hours after extubation

Secondary Outcomes (16)

• Numerical rating scale

  2-hour, 4-hour, 8-hour, 12-hour, 24-hour, 48-hour and 72-hour after extubation

• Patient satisfaction with pain management

  2-hour, 4-hour, 8-hour, 12-hour, 24-hour, 48-hour and 72-hour after extubation

• Postoperative morphine consumption

  2-hour, 4-hour, 8-hour, 12-hour, 24-hour, 48-hour and 72-hour after extubation

• Time for first morphine rescue

  Up to postoperative day 3, with time of first morphine required recorded

• Intraoperative opioid consumption

  Intraoperative record

Study Arms (2)

ITPB group

EXPERIMENTAL

Intertransverse process block is performed on patients with injection of 20ml 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

Sham block group

SHAM COMPARATOR

Sham intertransverse process block is performed on patients with injection of 20ml 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

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, 20 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 volume of study medication.

ITPB group

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, 20 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.

Sham block group

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 CABG, valve repair/replacement, or combined CABG/valve procedure via sternotomy

You may not qualify if:

• Emergency surgery
• redo surgery
• history of chronic pain or being on chronic opioids/sedatives
• renal failure with an estimated glomerular filtration rate ≤30 ml/min (calculated by Cockcroft-Gault formula)
• re-operation within 24 hours after surgery
• intraoperative use of remifentanil
• inability to provide informed consent.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (41)

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MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

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 27, 2025
• Study Start: January 2, 2026
• Primary Completion (Estimated): January 2, 2027
• Study Completion (Estimated): January 2, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)