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

Effect of Ultrasound-guided Rhombic Intercostal Nerve Block With Liposomal Bupivacaine Versus Bupivacaine Hydrochloride Combined With Dexamethasone in Thoracoscopic Pneumonectomy on Postoperative Pain: a Non-inferiority Study

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: Recruiting
• Conditions: Thoracic Surgery
• Intervention / Treatment: Procedure: Rhombic intercostal nerve block(Received liposomal bupivacaine 10 ml 133 mg and 0.5% bupivacaine 5 ml diluted to 30 ml); Procedure: Rhombic intercostal nerve block(Receive 0.5% standard bupivacaine 15 ml diluted to 30 ml with dexamethasone 4 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 130 thoracoscopic pneumonectomy patients between the ages of 18-80 years, ASA Physical Status I and III, who underwent elective or limited partial pneumonectomy and 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 133 mg combined with bupivacaine 25 mg, and the standard control group was treated with 0.5% bupivacaine hydrochloride 75 mg combined with dexamethasone 5 mg, and both groups were perfused with saline 30 ml. ultrasound-guided rhombic intercostal muscle nerve block was performed for a total of 30 ml. postoperative analgesia was provided using patient-controlled intravenous analgesia (PCIA), and according to the patient's weight and baseline condition, flurbiprofenac 50 mg or tramadol 100 mg rescue analgesia was given every 6 hours when resting VAS score was ≥4. Record cumulative consumption at 72 hours postoperatively. Quality of Recovery Score (QoR-15) at 72 hours postoperatively, Numeric Pain Rating Scale (NRS) at 6 hours to 3 months, and patient satisfaction were recorded.

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qinghe ZHOU, professor; Phone Number: 13732573379; Email: jxxmxy@163.com

Study Locations

• China
  • Zhejiang
    • Jiaxing, Zhejiang, China, 942111
      • Recruiting
      • The First hospital of Jiaxing
      • Contact: lei xie; Phone Number: 17334528826; Email: 17334528826@163.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. American Society of Anesthesiologists status I, II and III; 2.Thoracoscopic pneumonectomy

Exclusion Criteria:

1. Refusal of consent
2. Pregnancy
3. Conditions making the patient unable to fill out questionnaire online, through email or over the phone including with cognitive dysfunction, psychiatric disorder, or non-English speaking patients, or lack of internet access which would prevent post discharge follow-up electronically
4. Coagulopathy
5. Allergy to or for any other reasons cannot use local anesthetic bupivacaine, DEX
6. Insulin dependent or uncontrolled diabetes defined as, day of surgery finger stick glucose >200mg/dl, or HbA1C > 8.0%
7. Peripheral Nerve Block site or systemic infection
8. Immune compromise (e.g., HIV, chronic glucocorticoid use)
9. Severe pre-existing neuropathy
10. Severe hepatic or renal dysfunction (GFR <50 ml/min)
11. Actual body weight <60 kg
12. Patients with active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and non-specific ulcerative colitis

Study Plan

How is the study designed?

Design Details

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

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 10 ml of liposomal bupivacaine 133 mg and 5 ml of 0.5% bupivacaine diluted to 30 ml were injected into this space.	Procedure: Rhombic intercostal nerve block(Received liposomal bupivacaine 10 ml 133 mg and 0.5% bupivacaine 5 ml diluted to 30 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 10 ml 133 mg and 0.5% bupivacaine 5 ml diluted to 30 ml.
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 0.5% standard bupivacaine 15 ml diluted to 30 ml with dexamethasone 5 mg was injected into this space.	Procedure: Rhombic intercostal nerve block(Receive 0.5% standard bupivacaine 15 ml diluted to 30 ml with dexamethasone 4 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 0.5% standard bupivacaine 15 ml diluted to 30 ml with dexamethasone 4 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 pain score 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 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)	Day 1, 2 and 7 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).	Day 1 after surgery and Day 2 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
Length of hospital stay	The patient's post surgical length of stay in the hospital will be compared between treatment groups.	from the start of the surgery to discharge from hospital

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): April 5, 2024
• Primary Completion (Estimated): May 5, 2025
• Study Completion (Estimated): May 5, 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 (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

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