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

NCT06392191 | Completed

• 1 other identifier: 2024-KY-226
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thoracic Surgery

Keywords

Rhombic intercostal nerve block; thoracoscopy; Bupivacaine liposomes

Outcome Measures

Primary Outcomes (1)

• Area under the curve

  Area under the curve of the numeric rating scale (NRS) scores at rest

  0-48 hours after surgery

Secondary Outcomes (17)

• Change in functional pain using Brief Pain Inventory (BPI)

  Preoperative day one, 6 weeks after surgery, 3 months after surgery

• Change in Quality of Recovery 15 questionnaire

  Preoperative day one；Day 1, 2 and 7 after surgery

• Change in white blood cell count (WBC)

  Preoperative day one, day 0, day 1 and day 2 after surgery

• Length of hospital stay

  perioperatively

• Absolute value of Interleukin 1 beta (IL-1b)

  day 1 after surgery

Study Arms (2)

Bupivacaine liposomes group

OTHER

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)

Standard bupivacaine dexamethasone group

OTHER

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.)

Interventions

Rhombic intercostal nerve block(Received liposomal bupivacaine 93 mg and bupivacaine 25 mg diluted to 20 ml) PROCEDURE

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.

Bupivacaine liposomes group

Rhombic intercostal nerve block(Receive standard bupivacaine 105 mg diluted to 20 ml with dexamethasone 5 mg.) PROCEDURE

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.

Standard bupivacaine dexamethasone group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Affiliated Hospital of Jiaxing University: lead

Study Sites (1)

The First Hospital of Jiaxing

Jiaxing, Zhejiang, 942111, China

Location

Related Publications (3)

• 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.

  PMID: 36973139 RESULT

• 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.

  PMID: 30703673 RESULT

• Xie L, Xi Y, He X, An M, Jia X, Li Z, Chen T, Zhou Q. Liposomal Bupivacaine vs. Plain Bupivacaine with Dexamethasone for Rhomboid Intercostal Block in the Management of Postoperative Pain After Video-Assisted Thoracoscopic Surgery: A Randomized Non-inferiority Trial. Pain Ther. 2025 Oct;14(5):1513-1530. doi: 10.1007/s40122-025-00763-1. Epub 2025 Aug 4.

  PMID: 40758210 DERIVED

MeSH Terms

Interventions

Bupivacaine; Dexamethasone

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• QINGhe ZHOU, professor

  deputy chair of board

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Blinding of medical staff and investigators: a study coordinator was developed to keep and distribute the randomisation numbers, an independent nurse anaesthetist prepared the medication for the study according to the randomisation result code, because bupivacaine liposomes are milky and bupivacaine is colourless, we set up an independent medication preparer and nerve block operator, and nerve block operators were not permitted to be associated with anaesthesia procedures and postoperative Patient assessment. The anaesthesiologist and the follow-up physician were unaware of the grouping. Patients were blinded: all patients were anaesthetised and the nerve block was performed without the patients touching the drugs. The double blinding continued throughout the study period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 30, 2024
• Study Start: November 10, 2024
• Primary Completion: April 1, 2025
• Study Completion: May 2, 2025
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)