Comparison of Bupivacaine Liposomal vs Bupivacaine Combined With

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06392191
Study type	Interventional
Source	Affiliated Hospital of Jiaxing University
Contact	Qinghe ZHOU, professor
Phone	13732573379
Email	jxxmxy@163.com
Status	Recruiting
Phase	N/A
Start date	April 5, 2024
Completion date	May 5, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms