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.
Adult patients aged 18 or older
undergoing elective coronary artery bypass graft (CABG), valve repair/replacement, or combined CABG/valve procedure via sternotomy.
Emergency surgery
redo surgery
history of thoracotomy or mastectomy
patients with history of chronic pain
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, 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
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, 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.
Levobupivacaine 0.25%
DrugDrug used for intertransverse process block (intervention group)
Sodium Chloride (NaCl) 0.9 %
DrugAs placebo for sham block group
Ultrasound guided injection with local anaestethic
DevicePhilips EPIQ ultrasound system, with a curved array transducer (C5-1), and 80mm echogenic nerve block needle (SonoTAP; PAJUNK, Germany)
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.
Quality of recovery at 72 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.
Intraoperative opioid consumption
Intraoperative opioids other than morphine are converted into intravenous morphine equivalent dose, and dose of fentanyl used at anaesthesia induction is recorded.
Morphine consumption
Morphine consumption postoperatively
SBP change on incision for sternotomy
Systolic blood pressure changes following sternotomy are defined as percentage increase in systolic blood pressure (SBP) between the baseline and their peaks within 10 minutes of skin incision for sternotomy. All hemodynamic parameters are automatically recorded using the Anaesthesia Clinical Information System at one-minute interval.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
