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

Official title

Ultrasound-Guided Liposomal Bupivacaine Plus Bupivacaine Rhomboid Intercostal Block for Postoperative Pain Relief in Patients Undergoing Thoracoscopic Surgery:A Multi-Center Randomized Controlled Trial

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.

Interventions

• Drug Bupivacaine hydrochloride
  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. Postop
• Drug Liposomal bupivacaine plus bupivacaine
  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

Primary outcome measures

• Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively [Time frame: The postoperative period 48 hours.]

Secondary outcome measures (12)

• Area Under the Curve (AUC) of Numeric Rating Scale at rest (NRSr) Within 0-72 Hours Postoperatively [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 [Time frame: Postoperative hours 2, 24, 48, and 72; week 1; month 1; and month 3.]
• Ramsay Sedation Scale，RSS [Time frame: Postoperative at 2 hours, 24 hours, 48 hours, and 72 hours.]
• Quality of Recovery-40，QoR-40 [Time frame: Postoperative hours 24, 48, and 72.]
• The duration of stay in the post-anesthesia care unit（PACU） [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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Prevention

Study locations

China · 1 center

• Beijing Tiantan Hospital — Beijing

Publications

• Ciftci B, Alver S, Gungor H, Golboyu BE, Subasi M, Omur B, Gul YG, Ekinci M. The efficacy of rhomboid intercostal block for pain management after video-assisted thoracoscopic surgery: a prospective, randomized-controlled trial. Gen Thorac Cardiovasc Surg. 2024 Dec;72(12):779-785. doi: 10.1007/s11748-024-02036-8. Epub 2024 Apr 26. PMID 38668898
• Wang X, Jia X, Li Z, Zhou Q. Rhomboid intercostal block or thoracic paravertebral block for postoperative recovery quality after video-assisted thoracic surgery: A prospective, non-inferiority, randomised controlled trial. Eur J Anaesthesiol. 2023 Sep 1;40(9):652-659. doi: 10.1097/EJA.0000000000001872. Epub 2023 Jun 28. PMID 37377368
• Chen R, Su S, Shu H. Efficacy and safety of rhomboid intercostal block for analgesia in breast surgery and thoracoscopic surgery: a meta-analysis. BMC Anesthesiol. 2022 Mar 16;22(1):71. doi: 10.1186/s12871-022-01599-4. PMID 35296252
• Zhang JG, Jiang CW, Deng W, Liu F, Wu XP. Comparison of Rhomboid Intercostal Block, Erector Spinae Plane Block, and Serratus Plane Block on Analgesia for Video-Assisted Thoracic Surgery: A Prospective, Randomized, Controlled Trial. Int J Clin Pract. 2022 Jun 23;2022:6924489. doi: 10.1155/2022/6924489. eCollection 2022. PMID 35832798

Identifiers

NCT: NCT07441902 · KY2025-289-02-2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗