Revised-Paravertebral Nerve Blocks for Enhanced Recovery After Video-assisted Thoracoscopic Pneumonectomy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSixth Affiliated Hospital, Sun Yat-sen University

About this trial

Revised-Paravertebral Nerve Block (r-PVB) is performed right after induction of general anesthesia and before lateral positioning of surgery. Under ultrasound guidance, an intercostal space between the 6th and 8th ribs at the midaxillary line is identified. Using an in-plane technique, the needle is advanced into the internal intercostal muscle, and 30 mL of 0.5% ropivacaine is injected to achieve the block. Traditional Paravertebral Nerve Block (PVB) is performed right after the lateral positioning of surgery under ultrasound guidance. According to the operator's preference, choose any of the commonly used three traditional paravertebral block approaches. Among these 3 approaches, the axial plane approach is recommended as the first choice: use the convex probe to identify the 6th and 8th transverse processes, then scan cranially to display the superior costotransverse ligament, pleura, and paravertebral space. Under sterile conditions, insert the needle in-plane approximately 2 cm lateral to the probe, ensuring the ultrasound probe remains stable and dynamically visualizing the needle advancement. Stop advancing the needle when the tip passes through the superior costotransverse ligament. Administer 2% lidocaine in pulsatile injections, 1-2 ml per pulse, observing the spread of fluid at the needle tip on ultrasound and depression of the pleura. Repeat pulsatile injections until a total of 5 ml lidocaine is administered, and if necessary, increase with another 5 ml of pulsatile lidocaine. The fluid movement and pleura depression observed on ultrasound confirm proper needle placement. Then, use this needle to inject 30 ml of 0.5% ropivacaine to complete the PVB. The surgical procedure will start right after the intervention blocks.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18 years or older

Scheduled for elective video-assisted thoracoscopic pneumonectomy for benign or malignant diseases

Disqualifiers

Contraindications to nerve block, including skin infection at the puncture site, increased intracranial pressure, uncorrectable coagulopathy, bridging indication for therapeutic anticoagulation (CHADS-VASc ≥ 8), sepsis, or allergy to local anesthetics

Surgeon-estimated high likelihood of conversion to open surgery

Chronic opioid use

Heart failure, liver failure, or renal failure

Trial design

Design model

Parallel

Treatments tested in this trial

  • Revised-Paravertebral Nerve Block

    Procedure/Surgery

    Revised-Paravertebral Nerve Block (r-PVB) is performed after induction of general anesthesia and before the start of surgery. Under ultrasound guidance, an intercostal space between the 7th and 9th ribs at the midaxillary line is identified. Using an in-plane technique, the needle is advanced into the internal intercostal muscle, and 30 mL of 0.5% ropivacaine is injected to achieve the block.

  • Control

    Procedure/Surgery

    Paravertebral Nerve Block (PVB), the control of investigated intervention, is performed right after the lateral positioning of surgery under ultrasound guidance. According to the operator's preference, choose any of the commonly used three traditional paravertebral block approaches. Among these 3 approaches, the axial plane approach is recommended as the first choice: use the convex probe to identify the transverse process, then scan cranially to display the superior costotransverse ligament, pleura, and paravertebral space. Under sterile conditions, insert the needle in-plane approximately 2 cm lateral to the probe, ensuring the ultrasound probe remains stable and dynamically visualizing the needle advancement. Stop advancing the needle when the tip passes through the superior costotransverse ligament.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: r-PVBExperimental treatment 1 intervention
Group B: PVBOther 1 intervention

Trial outcomes

Primary outcomes

1

Mean postoperative NRS pain score during the first 2 postoperative days

Postoperative pain will be assessed using a Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain the patient can imagine). The primary pain outcome is the mean of 8 postoperative NRS pain scores collected in the post-anesthesia care unit, on the evening of surgery, and on postoperative days 1 and 2 (morning, midday, and evening).

Time frame
From post-anesthesia care unit through postoperative day 2
2

Mean QoR-15 score on postoperative days 1 and 2

Quality of recovery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15), ranging from 0 (the worst) to 150 (the best). The primary recovery outcome is the mean QoR-15 score measured on postoperative day 1 and postoperative day 2.

Time frame
Postoperative day 1 and postoperative day 2

Secondary outcomes

1

Resting and movement NRS pain scores on postoperative days 1 and 2

Resting and movement-related pain will be assessed using the Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain the patient can imagine), at predefined time points on postoperative days 1 and 2.

Time frame
Postoperative day 1 and postoperative day 2
2

Proportion of participants with pain score 4 or greater

The proportion of participants with clinically significant pain, defined as the Numerical Rating Scale (NRS, 0-10) of 4 or greater, will be compared between groups.

Time frame
Postoperative day 1 and postoperative day 2
3

Postoperative opioid and analgesic consumption

Postoperative opioid and other analgesic consumption will be recorded and compared between groups. Opioid use will be converted to oral morphine equivalents where appropriate.

Time frame
Postoperative day 1 and postoperative day 2
4

Postoperative complications

Postoperative complications, including pneumothorax, nausea, vomiting, dizziness, respiratory depression, and other adverse events, will be recorded and compared between groups.

Time frame
From surgery through postoperative day 30

Other outcomes

1

Incidence of local anesthetic systemic toxicity

The incidence of local anesthetic systemic toxicity (LAST) will be recorded and compared between groups.

Time frame
From intervention through postoperative day 30
2

Pain scores at 30 days after surgery

Resting and movement-related pain at 30 days after surgery will be assessed using the Numerical Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain the patient can imagine).

Time frame
Postoperative day 30
3

QoR-15 score at 30 days after surgery

Quality of recovery at 30 days after surgery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15), ranging from 0 (the worst) to 150 (the best).

Time frame
Postoperative day 30
4

Morbidity within 30 days after surgery

Postoperative morbidity within 30 days after surgery will be recorded and compared between groups.

Time frame
From surgery through postoperative day 30

Locations

This trial has no locations.

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