Thoracic Surgery Intercostal Block Trial With Liposomal vs. Hydrochloride Bupivacaine
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Pulmonary Hospital, Shanghai, China
About this trial
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.
Eligibility criteria
Qualifiers
Scheduled for elective unilateral thoracoscopic (VATS) lung surgery
Age 18 to 80 years
American Society of Anesthesiologists (ASA) physical status I-III
Disqualifiers
Contraindication to local anesthetics (infection at puncture site, allergy to local anesthetics, coagulopathy or other bleeding risk)
Sensory abnormalities in the planned chest-wall surgical area
Hepatic dysfunction (ALT > 50 U/L, AST > 40 U/L, or total bilirubin ≥ 19 μmol/L) or renal dysfunction (serum creatinine > 112 μmol/L, BUN > 7.1 mmol/L, or dialysis within 28 days before surgery)
Pregnancy, breastfeeding, women of childbearing potential not using adequate contraception, or planning pregnancy during the study period
Trial design
Treatments tested in this trial
- Liposomal Bupivacaine intercostal nerve block
- Bupivacaine Hydrochloride intercostal nerve block
- Standard Postoperative Analgesia
Treatment groups
210 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov