Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-28 @ 12:01 AM
Study NCT ID:
NCT07134660
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-05
First Post:
2025-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thoracic Surgery Intercostal Block Trial With Liposomal vs. Hydrochloride Bupivacaine
Sponsor:
Shanghai Pulmonary Hospital, Shanghai, China
Organization:
Study Overview
Official Title:
Analgesic Efficacy Between Liposomal Bupivacaine and Bupivacaine Hydrochloride in Intercostal Nerve Block for Thoracic Surgery: A Multicenter Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
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:
This randomized controlled trial evaluates the analgesic effects of liposomal bupivacaine compared to bupivacaine hydrochloride in intercostal nerve block for patients undergoing thoracoscopic lung surgery. Postoperative pain remains a significant issue in thoracic procedures, often leading to complications like pneumonia or delayed recovery. The investigators hypothesize that liposomal bupivacaine, with its extended-release properties, will provide superior pain relief beyond 24 hours compared to standard bupivacaine or no block. Participants will be randomized 1:1:1 to liposomal bupivacaine group , bupivacaine hydrochloride group , or control group . Primary outcome is the area under the curve of pain scores from 25-72 hours post-surgery. Secondary outcomes include opioid consumption, recovery quality (QoR-15), and other complications.
Detailed Description:
Background: Lung cancer surgery, even with minimally invasive thoracoscopy, causes significant postoperative pain in up to 62.9% of patients, potentially leading to complications and chronic pain. Intercostal nerve block is a safe alternative to epidural analgesia, but standard local anesthetics like bupivacaine provide limited duration (\<8 hours). Liposomal bupivacaineoffers prolonged release up to 72 hours.
Objective: To compare the analgesic efficacy of liposomal bupivacaine versus bupivacaine hydrochloride in intercostal nerve block, assessing pain scores, opioid use, recovery quality, and complications in thoracoscopic lung surgery patients.
Design: Multicenter, randomized controlled trial with 210 participants (70 per group). Randomization with (1:1:1).
Methods: Eligible patients receive ultrasound-guided intercostal block post-surgery: Liposomal bupivacaine (20 mL, 266 mg), bupivacaine HCl (20 mL, 0.25%), or control (IV PCA only). Follow-up includes pain scores, opioid consumption, QoR-15, and adverse events up to 72 hours.
Expected Outcomes: Liposomal bupivacaine expected to reduce pain AUC by \>10% vs. bupivacaine and \>15% vs. control from 25-72 hours.
Objective: To compare the analgesic efficacy of liposomal bupivacaine versus bupivacaine hydrochloride in intercostal nerve block, assessing pain scores, opioid use, recovery quality, and complications in thoracoscopic lung surgery patients.
Design: Multicenter, randomized controlled trial with 210 participants (70 per group). Randomization with (1:1:1).
Methods: Eligible patients receive ultrasound-guided intercostal block post-surgery: Liposomal bupivacaine (20 mL, 266 mg), bupivacaine HCl (20 mL, 0.25%), or control (IV PCA only). Follow-up includes pain scores, opioid consumption, QoR-15, and adverse events up to 72 hours.
Expected Outcomes: Liposomal bupivacaine expected to reduce pain AUC by \>10% vs. bupivacaine and \>15% vs. control from 25-72 hours.
Study Oversight
Has Oversight DMC:
True
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?:
None
Is an FDA AA801 Violation?: