The Efficacy and Safety of Liposomal Bupivacaine for Rhomboid Intercostal Nerve Block in Relieving Postoperative Pain After Video-assisted Thoracoscopic Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorBeijing Tiantan Hospital

About this trial

Video-assisted thoracoscopic surgery (VATS) is less invasive compared to traditional thoracotomy. It is reported that the incidence of acute pain following VATS exceeds 80%. Inadequate postoperative analgesia may trigger a series of adverse physiological stress responses, increase the occurrence of postoperative complications, and affect the rehabilitation process.If acute pain is not managed promptly and sufficiently, nearly one-quarter of patients may develop chronic pain, impacting normal life and sleep quality after discharge.In recent years, multimodal postoperative analgesia protocols have been increasingly adopted in clinical practice. The Rhomboid intercostal block (RIB), as a novel regional anesthesia technique within the multimodal analgesia framework, has been widely utilized in various thoracic surgical procedures. Liposomal bupivacaine, an innovative long-acting sustained-release amide local anesthetic, provides prolonged analgesia for up to 72 hours. However, its efficacy and safety in video-assisted thoracoscopic surgery (VATS) have not yet been fully validated. Based on this premise, the present study aims to evaluate and compare the clinical outcomes of ultrasound-guided Rhomboid intercostal block (RIB) utilizing liposomal bupivacaine combined with conventional bupivacaine for postoperative pain management in patients undergoing VATS.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients scheduled for elective video-assisted thoracoscopic lobectomy or wedge resection under general anesthesia;

Ages 18 to 64 years old;

American Society of Anesthesiologists (ASA) physical status of I-III;

Glasgow Coma Scale (GCS) score of 15;

Disqualifiers

History of chronic pain syndrome of any cause.

Patients with heart conduction block (sinus block or atrioventricular block).

Patients with unstable coronary artery disease.

Patients with gastric ulcer or gastric bleeding.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bupivacaine hydrochloride

    Drug

    Prior to surgical incision, the Doppler ultrasound-guided injection technique will be employed. A 22-gauge block needle will be inserted at the medial border of the scapula at the T5-T6 vertebral level using an in-plane approach. Upon reaching the rhomboid-intercostal fascial plane, 20 mL of 0.25% bupivacaine will be administered. The patient-controlled analgesia (PCA) pump solution consists of 100 μg sufentanil and 16 mg ondansetron diluted with normal saline to a total volume of 100 mL. Postoperatively, patients may self-administer a 2-mL bolus per demand, with a lockout interval of 10 minutes. Should analgesia remain inadequate after four consecutive boluses, one tablet of oxycodone-acetaminophen(containing 5 mg oxycodone hydrochloride and 325 mg acetaminophen) may be administered orally, with a minimum repeat dosing interval of 6 hours. For persistent pain, intravenous morphine 5 mg may be administered at intervals no shorter than 4 hours.

  • Liposomal bupivacaine plus bupivacaine

    Drug

    Prior to surgical incision, the Doppler ultrasound-guided injection technique will be employed. A 22-gauge block needle will be inserted at the medial border of the scapula at the T5-T6 vertebral level using an in-plane approach. Upon reaching the rhomboid-intercostal fascial plane, 20 mL of a mixed solution-comprising 10 mL of liposomal bupivacaine (133 mg) and 10 mL of 0.25% bupivacaine diluted in normal saline-will be administered. The patient-controlled analgesia (PCA) pump solution consists of 100 μg sufentanil and 16 mg ondansetron diluted with normal saline to a total volume of 100 mL. Postoperatively, patients may self-administer a 2-mL bolus per demand, with a lockout interval of 10 minutes. Should analgesia remain inadequate after four consecutive boluses, one tablet of oxycodone-acetaminophen may be administered orally, with a minimum repeat dosing interval of 6 hours. For persistent pain, intravenous morphine 5 mg may be administered at intervals no shorter than 4 hours.

Treatment groups

134 Participants
are divided into 2 treatment groups
Group A: Bupivacaine hydrochlorideActive comparator 1 intervention
Group B: Liposomal bupivacaine plus bupivacaineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively

Time frame
The postoperative period 48 hours.

Secondary outcomes

1

Area Under the Curve (AUC) of Numeric Rating Scale at rest (NRSr) Within 0-72 Hours Postoperatively

The Numeric Rating Scale (NRS) designates 0 as representing no pain and 10 as representing the most severe pain; scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain.

Time frame
Data will be collected at 2 hours, 24 hours, 48 hours, and 72 hours postoperatively.
2

Numeric Rating Scale at rest (NRSr) at 1 week, 1 month, and 3 months postoperatively

The Numeric Rating Scale (NRS) designates 0 as representing no pain and 10 as representing the most severe pain; scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain.

Time frame
Postoperative day 7, month 1, and month 3.
3

Time to request of first analgesia

Time frame
Within 48 hours postoperatively.
4

Cumulative sufentanil dose for four separate periods (0-4, 4-8, 8-24, and 24-48 h), a total press count including both valid and invalid presses

Time frame
Postoperative Hours 4, 8, 24, and 48.

Other outcomes

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