Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06392191
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-04-08
Brief Title:
Comparison of Bupivacaine Liposomal vs Bupivacaine Combined With Dexamethasone for Postoperative Pain in VATS
Sponsor:
Affiliated Hospital of Jiaxing University
Organization:
Affiliated Hospital of Jiaxing University
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 93 mg combined with bupivacaine 25 mg and the standard control group was treated with 0525 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 patient39s 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
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 0525 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 patient39s 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None