The objective of this study is to evaluate the efficacy, safety, and tolerability of bupivacaine liposomes for paravertebral nerve block in the treatment of thoracoscopic postoperative pain, and to evaluate the relevant human pharmacokinetics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
96
Bupivacaine Liposome Injection Low Dose or Moderate Dose or High Dose
Bupivacaine Hydrochloride Injection Low Dose or Moderate Dose or High Dose
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGArea under the time curve of pain intensity during exercise (or cough) for 72 hours after administration
Time frame: 0 minute to 72 hours after administration
Area under the curve of pain intensity and time in exercise (or cough) state in 0-12h, 12-24h, 12-48h and 12-72h after administration
Time frame: 0 minute to 72 hours after administration
Area under the curve of pain intensity and time in resting state in 0-12h, 12-24h, 12-48h, 12-72h and 0-72h after administration
Time frame: 0 minute to 72 hours after administration
Pain intensity scores in resting state and exercise (or cough) state, including within 30 minutes after anesthesia recovery and various time points after administration (6h, 8h, 12h, 18h, 24h, 30h, 36h, 48h, 72h)
Time frame: recovery from anesthesia to 72 hours after administration
The duration of the first pain intensity score ≥4 points during exercise (or cough) after anesthesia recovery
Time frame: 0 minute to 72 hours after administration
The duration of the first pain intensity score ≥4 points at rest after anesthesia recovery
Time frame: 0 minute to 72 hours after administration
Maximum pain intensity score during exercise (or cough) within 72 hours after administration
Time frame: 0 minute to 72 hours after administration
Percentage of painless (pain intensity score ≤1 at rest) subjects at planned time points
Time frame: 0 minute to 72 hours after administration
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Proportion of subjects who did not use remedial analgesia in 0-12h, 12-24h, 24-48h, 48-72h, 0-72h
Time frame: 0 minute to 72 hours after administration
Cumulative use of remedial analgesics in 0-12h, 12-24h, 24-48h, 48-72h, 0-72h
Time frame: 0 minute to 72 hours after administration
Time of first use of remedial analgesics
The first time additional analgesic medication is required due to insufficient analgesic efficacy.
Time frame: The time of the first pain intensity rating to 72 hours after administration
Subjects' analgesic satisfaction scores
Time frame: 72 hours after administration
Investigators' analgesic satisfaction scores
Time frame: 72 hours after administration