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. To investigate the quality of recovery after cardiac surgery, and its analgesic efficacy in the immediate postoperative period 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. 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
adult patients aged 18 or older
undergoing elective CABG, valve repair/replacement, or combined CABG/valve procedure via sternotomy
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)
Parallel
Intertransverse process block
Procedure/SurgeryAll 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.
Sham block
Procedure/SurgeryAll 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.
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.
Numerical rating scale
Pain scores after extubation. It is a 11-points scale from 0 to 10, with zero score means no pain, and 10 score means the worst pain ever
Patient satisfaction with pain management
Assessment on patient satisfaction with pain management at predefined time point after extubation. The patients are asked to rate the overall satisfaction to pain management on a verbal analogue scale (0=worst possible, 100=best possible)
Postoperative morphine consumption
Postoperative morphine consumption at predefined time point after extubation
Time for first morphine rescue
Time for first morphine rescue (in minutes)
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