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

N/ARecruitingNCT07441902

Beijing Tiantan Hospital134 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

134

Conditions

Video-assisted Thoracoscopic Surgery (VATS)

Interventions

Bupivacaine hydrochlorideDRUG

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 bupivacaineDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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； * Patients must be able to understand the nature and potential personal consequences of the clinical trial, signing of the informed consent form. Exclusion Criteria: * 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. * Patients with diabetes and are being treated with insulin. * Subjects with coagulation dysfunction (prothrombin time or activated partial thromboplastin time is higher than the normal threshold) or patients who are taking oral anticoagulants for other medical reasons and have not stopped it before surgery, such as warfarin or new anticoagulants rivaroxaban or dabigatran. * Patients with abnormal liver function: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 2× the upper limit of normal (ULN) or total bilirubin (TBIL) ≥ 1.5×ULN. * Patients with renal impairment (serum creatinine \> 176 µmol/L) or receiving dialysis treatment within 28 days before surgery. * Patients with a history of diagnosed mental illness or currently taking psychotropic medication. * Excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks or 3 days per week for more than 1 month), use of drugs with confirmed or suspected sedative or analgesic effects, or use of any painkiller within 24 h before surgery. * Pregnancy or breastfeeding. * Extreme body mass index (BMI) (\< 15 or \> 35). * Participation in another interventional trial that interferes with the intervention or outcome of this trial. * Patients with a history of allergy to local anaesthetics or one of the study drugs.

Outcomes

Primary Outcomes

Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively

Time frame: The postoperative period 48 hours.

Secondary Outcomes

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.

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

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

Time to request of first analgesia

Time frame: Within 48 hours postoperatively.

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.

Duration days of Oral Oxycodone and Acetaminophen Tablets Administration

Time frame: Within 3 months postoperatively.

Intraoperative Anesthetic Dosage

Time frame: During the surgical anesthesia phase.

Patient Satisfaction Scale，PSS

Patient Satisfaction Scale(PSS) on a scale ranging from 0 to 10, where 0 denotes "completely dissatisfied" and 10 signifies "extremely satisfied."

Time frame: Postoperative hours 2, 24, 48, and 72; week 1; month 1; and month 3.

Ramsay Sedation Scale，RSS

The RSS utilizes a six-point scale to evaluate sedation levels. The total score ranges from 1 to 6 as follows: anxious or agitated (1 point); oriented, calm, and cooperative (2 points); responsive to commands (3 points); drowsy with brisk response to glabellar tap or loud auditory stimulus (4 points); drowsy with sluggish response to glabellar tap or loud auditory stimulus (5 points)；and drowsy with no response whatsoever（6）points. A score of 1 reflects inadequate sedation, scores of 2 to 4 indicate satisfactory sedation, while scores of 5 to 6 denote oversedation.

Time frame: Postoperative at 2 hours, 24 hours, 48 hours, and 72 hours.

Quality of Recovery-40，QoR-40

The Quality of Recovery-40 (QoR-40) serves as a globally recognized metric for evaluating the quality of recovery. It encompasses five dimensions-emotional state, physical comfort, physiological independence, psychological support, and pain-comprising a total of 40 items, each rated on a 1-5 scoring scale. The overall QoR-40 score ranges from 40 (indicating extremely poor recovery quality) to 200 (representing excellent recovery quality).

Time frame: Postoperative hours 24, 48, and 72.

The duration of stay in the post-anesthesia care unit（PACU）

The time from the end of surgery until the patient regains consciousness and has stable vital signs after extubating and is subsequently transferred back to the ward.

Time frame: The time from the end of surgery until transferred back to the ward.Typically, patients are transferred back to the ward after approximately 30 to 60 minute.

Length of Stay (LOS)

Time frame: Perioperation.

Total hospitalization expenses incurred during the patient's inpatient stay

Time frame: Perioperation.

Postoperative nausea and vomiting，PONV

Time frame: Postoperatively within 72 hours.

Adverse events，AEs

Systemic Toxicity of Local Anesthetics (LAST), localized hematoma, pruritus, hypotension, arrhythmia, delirium, etl.

Time frame: Within 72 hours postoperatively.

Total dosage of orally oxycodone and acetaminophen tablets