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NCT Number: NCT07134660

Thoracic Surgery Intercostal Block Trial With Liposomal vs. Hydrochloride Bupivacaine

This randomized controlled trial evaluates the analgesic effects of liposomal bupivacaine compared to bupivacaine hydrochloride in intercostal nerve block for patients undergoing thoracoscopic lung surgery. Postoperative pain remains a significant issue in thoracic procedures, often leading to complications like pneumonia or delayed recovery. The investigators hypothesize that liposomal bupivacaine, with its extended-release properties, will provide superior pain relief beyond 24 hours compared to standard bupivacaine or no block. Participants will be randomized 1:1:1 to liposomal bupivacaine group , bupivacaine hydrochloride group , or control group . Primary outcome is the area under the curve of pain scores from 25-72 hours post-surgery. Secondary outcomes include opioid consumption, recovery quality (QoR-15), and other complications.

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Key information

Conditions

Postoperative Pain, Acute Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Respiratory Tract Diseases Respiratory Tract Neoplasms Signs and Symptoms Thoracic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Background: Lung cancer surgery, even with minimally invasive thoracoscopy, causes significant postoperative pain in up to 62.9% of patients, potentially leading to complications and chronic pain. Intercostal nerve block is a safe alternative to epidural analgesia, but standard local anesthetics like bupivacaine provide limited duration (<8 hours). Liposomal bupivacaineoffers prolonged release up to 72 hours.

Objective: To compare the analgesic efficacy of liposomal bupivacaine versus bupivacaine hydrochloride in intercostal nerve block, assessing pain scores, opioid use, recovery quality, and complications in thoracoscopic lung surgery patients.

Design: Multicenter, randomized controlled trial with 210 participants (70 per group). Randomization with (1:1:1).

Methods: Eligible patients receive ultrasound-guided intercostal block post-surgery: Liposomal bupivacaine (20 mL, 266 mg), bupivacaine HCl (20 mL, 0.25%), or control (IV PCA only). Follow-up includes pain scores, opioid consumption, QoR-15, and adverse events up to 72 hours.

Expected Outcomes: Liposomal bupivacaine expected to reduce pain AUC by >10% vs. bupivacaine and >15% vs. control from 25-72 hours.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Scheduled for elective unilateral thoracoscopic (VATS) lung surgery
  • Age 18 to 80 years
  • American Society of Anesthesiologists (ASA) physical status I-III

Exclusion criteria

  • Contraindication to local anesthetics (infection at puncture site, allergy to local anesthetics, coagulopathy or other bleeding risk)
  • Sensory abnormalities in the planned chest-wall surgical area
  • Hepatic dysfunction (ALT > 50 U/L, AST > 40 U/L, or total bilirubin ≥ 19 μmol/L) or renal dysfunction (serum creatinine > 112 μmol/L, BUN > 7.1 mmol/L, or dialysis within 28 days before surgery)
  • Pregnancy, breastfeeding, women of childbearing potential not using adequate contraception, or planning pregnancy during the study period
  • Preoperative opioid use, history of chronic pain, or history of opioid abuse
  • Refusal to provide informed consent

Treatment and study plan

Liposomal Bupivacaine intercostal nerve block

Procedure

Ultrasound-guided intercostal nerve block with liposomal bupivacaine 266 mg (20 mL total; 4 mL per intercostal space at the incision and adjacent spaces), performed at the end of surgery before emergence from anesthesia. All patients receive standard postoperative analgesia with intravenous patient-controlled opioid analgesia.

Bupivacaine Hydrochloride intercostal nerve block

Procedure

Ultrasound-guided intercostal nerve block with 0.25% bupivacaine hydrochloride (20 mL total; 4 mL per intercostal space at the incision and adjacent spaces), performed at the end of surgery before emergence from anesthesia. All patients receive standard postoperative analgesia with intravenous patient-controlled opioid analgesia.

Standard Postoperative Analgesia

Other

No intercostal nerve block. Patients receive standard postoperative analgesia consisting of an intravenous patient-controlled opioid pump per institutional protocol.

Primary outcomes

  1. Pain score area under the curve (AUC) from 25 to 72 hours postoperatively

    Time frame: 25 to 72 hours after the end of surgery

    Area under the curve of postoperative pain intensity measured on the VRS. AUC is computed over the 25-72 h interval. Postoperative pain intensity assessed using the Verbal Response Scale (VRS), the score ranges from 0 to 10, with a total of 11 numbers corresponding to different pain levels: 0 indicates no pain; 1-3 indicates mild pain (tolerable and does not affect sleep); 4-6 indicates moderate pain (significant, affects sleep, and requires medication for relief); and 7-10 indicates severe pain (intense, intolerable, and severely affects life).

Secondary outcomes

  1. Pain score at PACU discharge and postoperative intervals

    Time frame: At PACU discharge, and 6, 12, 24, 48, and 72 hours postoperatively

    Pain intensity assessed using the VRS in the post-anesthesia care unit (PACU) and at 6, 12, 24, 48, and 72 hours after surgery. Postoperative pain intensity assessed using the Verbal Response Scale (VRS), the score ranges from 0 to 10, with a total of 11 numbers corresponding to different pain levels: 0 indicates no pain; 1-3 indicates mild pain (tolerable and does not affect sleep); 4-6 indicates moderate pain (significant, affects sleep, and requires medication for relief); and 7-10 indicates severe pain (intense, intolerable, and severely affects life).Rescue analgesia is provided if VRS >4.

  2. Cumulative opioid consumption

    Time frame: From the end of surgery to 48 hours after surgery

    Total postoperative opioid use converted to morphine milligram equivalents.

Other outcomes

  1. Duration of chest wall analgesia

    Time frame: From intervention (end of surgery) up to 7 days

    Time from performance of the intercostal nerve block (end of surgery) to return of chest-wall sensation, as determined by cold and pinprick testing at predefined chest-wall sites.

  2. Quality of Recovery (QoR-15) score

    Time frame: 24, 48, and 72 hours after surgery

    Measured by the QoR-15 questionnaire (15 items, total score 0-150; higher scores indicate better recovery).

  3. Incidence of postoperative nausea and vomiting

    Time frame: 24, 48, and 72 hours postoperatively

    Number of patients of nausea or vomiting recorded at 24, 48, and 72 hours after surgery.

  4. Incidence of postoperative pulmonary complications

    Time frame: From intervention (end of surgery) up to 7 days

    Occurrence of postoperative pulmonary complications-including pneumonia, atelectasis, acute respiratory distress syndrome (ARDS), and aspiration-defined by CDC and Berlin criteria.

  5. Length of hospital stay

    Time frame: From intervention (end of surgery) up to 7 days

    Time from end of surgery to discharge, measured in days.

Study contacts

Contact information is provided by the study sponsor or research team.

Shiyou Wei, PhD

CONTACT

[email protected]

8615601680288

Xin Lv, PhD

CONTACT

[email protected]

8618852869700

Sponsors and collaborators

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Other

Registry information

Official study title

Analgesic Efficacy Between Liposomal Bupivacaine and Bupivacaine Hydrochloride in Intercostal Nerve Block for Thoracic Surgery: A Multicenter Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2025
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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