Comparison of Bupivacaine Liposomal vs Bupivacaine Combined With Dexamethasone for Postoperative Pain in VATS

Effects of Liposomal Bupivacaine Combined With Bupivacaine and Dexamethasone for Rhomboid Intercostal Block on Postoperative Pain Following Video-Assisted Thoracoscopic Surgery: A Non-inferiority, Double-blind, Randomized Trial.

The purpose of this study, is to investigate the effectiveness of ultrasound-guided rhombic intercostal nerve block for postoperative pain control in thoracoscopic pulmonary resection with bupivacaine liposomes versus bupivacaine hydrochloride with dexamethasone to assess whether bupivacaine liposomes will produce analgesia superior to bupivacaine hydrochloride with dexamethasone in terms of analgesia effect and duration of analgesia. This study will also evaluate whether liposomal bupivacaine after nerve block improves the quality of postoperative recovery compared to bupivacaine hydrochloride combined with dexamethasone.

Study Overview

• Status: Completed
• Conditions: Thoracic Surgery
• Intervention / Treatment: Procedure: Rhombic intercostal nerve block(Received liposomal bupivacaine 93 mg and bupivacaine 25 mg diluted to 20 ml); Procedure: Rhombic intercostal nerve block(Receive standard bupivacaine 105 mg diluted to 20 ml with dexamethasone 5 mg.)

Detailed Description

Approved by the Ethics Committee of Jiaxing No. 1 Hospital (approval number: 2024-KY-226). This study was enrolled prior to patient enrollment in the clinical trial. Written informed consent was obtained from all participants. The study is expected to be conducted from April 2024 through December 2025. This study enrolls 90 elective thoracoscopic lung resection surgery(including wedge resection, segmentectomy, or lobectomy) patients between the ages of 18-80 years, ASA Physical Status I and III, who had no allergic reaction to the study drug.

Basic monitoring such as electrocardiogram, pulse oximetry, and noninvasive blood pressure were arranged preoperatively. The bupivacaine liposome group was treated with bupivacaine liposome 93 mg combined with bupivacaine 25 mg, and the standard control group was treated with bupivacaine hydrochloride 105 mg combined with dexamethasone 5 mg, and both groups were perfused with saline 20 ml. ultrasound-guided rhombic intercostal muscle nerve block was performed for a total of 20 ml. postoperative analgesia was provided using patient-controlled intravenous analgesia (PCIA), and according to the patients weight and baseline condition. Upon arrival of postoperative patients to the ward, if the patient reports significant pain, defined as the numeric rating scale (NRS), score greater than 3, the first step is to administer one press of the analgesic pump. If the pain persists, the pain management protocol will be initiated. Cumulative PCIA consumption at different postoperative time intervals (including 0-24 hours, 24-48 hours, and 48-72 hours). Quality of Recovery Score (QoR-15) at 72 hours postoperatively, If NRS at 6 hours to 3 months, and patient satisfaction were recorded.Pain assessments were performed at the following time points: 0 hours postoperatively (upon tracheal extubation and patient awakening), 0.5 hours, 2 hours, 4 hours, 12 hours, 24 hours, 48 hours, and 72 hours. Pain score follow-up by telephone at the third month.

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Jiaxing, Zhejiang, China, 942111
      • The First Hospital of Jiaxing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

ASA physical status I-III, aged between 18 and 80 years, scheduled for elective thoracoscopic lung resection surgery under general anesthesia with endotracheal intubation (including wedge resection, segmentectomy, or lobectomy) with one or three incisions, expected duration of surgery less than 4 hours, and body mass index (BMI) between 18 and 30 kg/m².

Exclusion Criteria:

1. trauma or emergency patients;
2. patients classified as New York Heart Association (NYHA) functional class 3-4;
3. unstable coronary artery disease patients;
4. patients with renal system diseases (estimated glomerular filtration rate <30 mL/min/1.73 m²);
5. patients with liver system diseases (alanine aminotransferase or aspartate aminotransferase levels exceeding twice the normal value);
6. patients with coagulation disorders, or those who have not discontinued warfarin or novel anticoagulants (such as rivaroxaban, dabigatran) prior to surgery;
7. individuals with a history of alcohol abuse or substance dependence within the past two months;
8. patients with uncontrolled anxiety, schizophrenia, or other psychiatric disorders;
9. pregnant or planning to become pregnant women;
10. individuals with a history of allergy to local anesthetics or investigational drugs. Additionally, patients who refuse to sign the informed consent form will also be excluded;
11. chronic pain syndromes (defined as reflex sympathetic dystrophy or complex regional pain syndrome);
12. chronic opioid use (longer than 3 months or daily morphine equivalents more than 5 mg/day for 1 month).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Bupivacaine liposomes group; The nerve block puncture needle was imaged and then entered into the fascial space between the rhomboid and extracostal muscles, and liposomal bupivacaine 93 mg and bupivacaine 25mg diluted to 20 ml were injected into this space.	Procedure: Rhombic intercostal nerve block(Received liposomal bupivacaine 93 mg and bupivacaine 25 mg diluted to 20 ml); The patient was placed in lateral recumbency and placed medial to the medial border of the scapula in the oblique sagittal plane using a line array ultrasound probe to identify ultrasound landmarks, trapezius, obliques, intercostals, pleura, and lungs, The block needle was then entered in-plane at the T5 level, with the margins retracting on insertion, and the nerve block perforating needle was imaged and then inserted into the fascial gap between the trapezius and the external intercostal muscles. Receive liposomal bupivacaine 93 mg and bupivacaine 25 mg diluted to 20ml.
Other: Standard bupivacaine dexamethasone group; The nerve block puncture needle was imaged and then entered into the fascial space between the rhomboid and external intercostal muscles, and a mixture of: receive standard bupivacaine 105 mg diluted to 20 ml with dexamethasone 5 mg was injected into this space.	Procedure: Rhombic intercostal nerve block(Receive standard bupivacaine 105 mg diluted to 20 ml with dexamethasone 5 mg.); The patient was placed in lateral recumbency and placed medial to the medial border of the scapula in the oblique sagittal plane using a line array ultrasound probe to identify ultrasound landmarks, trapezius, obliques, intercostals, pleura, and lungs, The block needle was then entered in-plane at the T5 level, with the margins retracting on insertion, and the nerve block perforating needle was imaged and then inserted into the fascial gap between the trapezius and the external intercostal muscles. A mixture of standard bupivacaine 105 mg diluted to 20 ml with dexamethasone 5 mg was received.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the curve	Area under the curve of the numeric rating scale (NRS) scores at rest	0-48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in functional pain using Brief Pain Inventory (BPI)	Compare functional pain using the BPI at baseline, 6 weeks and 3 months. The BPI scale defines pain as follows: Score: 1 - 4 = Mild Pain, Score: 5 - 6 = Moderate Pain, Score: 7 - 10 = Severe Pain.	Preoperative day one, 6 weeks after surgery, 3 months after surgery
Change in white blood cell count (WBC)	Compare the change in postoperative WBC from baseline only for participants that have an overnight hospital stay	Preoperative day one, day 0, day 1 and day 2 after surgery
Absolute value of Interleukin 1 beta (IL-1b)	Absolute value IL-1b at postoperative day 1 only for participants that have an overnight hospital stay	day 1 after surgery
Change in Quality of Recovery 15 questionnaire	15 questions assessing the quality of recovery, rated on a ten-point scale with a total score ranging from 0 (very poor recovery) to 150 (good recovery)	Preoperative day one；Day 1, 2 and 7 after surgery
CD3、CD4、CD4/CD8 and CD16+56	Postoperative day 1 CD3, CD4, CD4/CD8 and CD16+56 only for participants who were hospitalised overnight and pathologically had lung cancer	Preoperative day one，day 1 after surgery
Length of hospital stay	The patient post surgical length of stay in the hospital will be compared between treatment groups.	perioperatively
Absolute value of Interleukin 6 (IL-6)	Absolute value IL-6 at postoperative day 1 only for participants that have an overnight hospital stay	day 1 after surgery
C-reactive protein (CRP)	Absolute value C-reactive protein at postoperative day 1 only for participants that have an overnight hospital stay	day 1 after surgery
Postoperative chest Pain Score	Average postoperative chest pain scores for the first two postoperative days using numerical rating scale (NRS) pain score. Score range from 0 (no pain) to 10 (worst pain possible).	Preoperative day one；Day 1 after surgery; Day 2 after surgery; Day 3 after surgery
postoperative complications	Postoperative complications include arrhythmia, bowel obstruction, atrial fibrillation, and other cardiorespiratory systems.	perioperatively
mean arterial pressure	Changes in haemodynamics during surgery	Start of surgery to end of surgery
systolic blood pressure	Changes in haemodynamics during surgery	Start of surgery to end of surgery
diastolic blood pressure	Changes in haemodynamics during surgery	Start of surgery to end of surgery
heart rate	Changes in haemodynamics during surgery	Start of surgery to end of surgery
liver function	Transaminases in biochemical indicators	perioperatively
kidney function	Creatinine in biochemical indicators	perioperatively
Incidence of remedial analgesia	Remedial analgesia was given when the patient's numerical analogue score (NRS) was greater than 3 in the postoperative period	perioperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
lung injury	The injury of the lung specimen was evaluated through light microscopy by a pathologist who was blinded to the study. Lung injury was quantified using a 4-point scoring system.	day 1 after surgery

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Jiaxing University
• Investigators: Principal Investigator: QINGhe ZHOU, professor, deputy chair of board

Publications and helpful links

General Publications

• Elsharkawy H, Ince I, Pawa A. Rhomboid intercostal and sub-serratus (RISS) plane block for analgesia after lung transplant. J Clin Anesth. 2019 Sep;56:85-87. doi: 10.1016/j.jclinane.2019.01.042. Epub 2019 Jan 28. No abstract available.
• Xie Y, Yan D, Shen J. Video-assisted thoracic surgery versus thoracotomy for treatment of patients with pulmonary sequestration: A systematic review and meta-analysis. Asian J Surg. 2023 Aug;46(8):3387-3388. doi: 10.1016/j.asjsur.2023.03.097. Epub 2023 Mar 25. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2024
• Primary Completion (Actual): April 1, 2025
• Study Completion (Actual): May 2, 2025

Study Registration Dates

• First Submitted: April 8, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 28, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: thoracoscopy; Rhombic intercostal nerve block; Bupivacaine liposomes
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Antineoplastic Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Dexamethasone; Bupivacaine
• Other Study ID Numbers: 2024-KY-226

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No