The goal of this clinical trial is to evaluate the efficacy and safety of liposomal Bupivacaine administered by paravertebral block for the treatment of acute and chronic pain after video-assisted thoracoscopic lobectomy.
Researchers will compare liposomal bupivacaine to bupivacaine to see if liposomal bupivacaine works better to treat acute and chronic pain after video-assisted thoracoscopic lobectomy.Participants will:1.Received liposomal bupivacaine or bupivacaine paravertebral block before surgery. 2.Keep a diary of their pain scores within 30min after recovery from anesthesia and 6h, 12h, 24h, 48h, 72h and 90d after the beginning of injection of experimental drugs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
284
Participants randomized to the intervention arm received 266 mg of liposomal bupivacaine for paravertebral block before surgery.(The volume was expanded to 30 mL with normal saline).
Participants randomized to the intervention arm received 0.5% 100 mg of bupivacaine hydrochloride for paravertebral block before surgery.(The volume was expanded to 30 mL with normal saline)
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGArea under the movement-evoked pain intensity-time curve
Area under the pain intensity-time curve in the movement (or coughing) state within 72h after the intervention.
Time frame: from 0-72 hours after the intervention
The incidence of chronic postoperative pain
The incidence of chronic postoperative pain at 90 days
Time frame: postoperative day (POD) 90
Area under the rest pain intensity-time curve
Area under the pain intensity-time curve at rest within 72h after the intervention.
Time frame: from 0-72 hours after the intervention
Movement-evoked pain score
Use pain Numeric Rating Scale(NRS) to evaluate the movement-evoked pain score at 30minutes after recovery from anesthesia and at 6 hours, 12hours, 24hours , 48hours and 72 hours after the intervention.(NRS scale 0-10, where 0 was no pain, and 10 was the worst possible pain)
Time frame: 30 minutes after recovery from anesthesia,6 hours, 12hours, 24hours , 48hours and 72 hours after the intervention
Pain score at rest
Use pain Numeric Rating Scale(NRS) to evaluate the pain score at rest at 30minutes after recovery from anesthesia and at 6 hours, 12hours, 24hours , 48hours and 72 hours after the intervention.(NRS scale 0-10, where 0 was no pain, and 10 was the worst possible pain)
Time frame: 30 minutes after recovery from anesthesia,6 hours,12hours, 24hours , 48hours and 72 hours after the intervention
Proportion of participants who did not use rescue analgesia
Proportion of participants who did not use rescue analgesia during 0-12 hours, 12-24 hours, 24-48 hours, 48-72 hours and 0-72 hours after the intervention.
Time frame: from 0-72 hours after the intervention
The cumulative dosage of rescue analgesia
The cumulative dosage of rescue analgesia during 0-12 hours, 12-24 hours, 24-48 hours, 48-72hours and 0-72hours after the intervention.
Time frame: from 0-72 hours after the intervention
The time of first use of rescue analgesia
The time of first use of rescue analgesia
Time frame: from 0-72 hours after the intervention
First time out-of-bed
Time of participant's first out-of-bed activity after surgery
Time frame: From date of surgery until the date of first out-of-bed,assessed up to 7 days
Length of hospital stay
Duration of participants from hospital admission to hospital discharge
Time frame: From date of surgery until the date of first hospital discharge,assessed up to 1 months
Chronic pain score
Use pain Numeric Rating Scale(NRS) to evaluate the movement-evoked pain score and rest pain score at 90 days after surgery.(NRS scale 0-10, where 0 was no pain, and 10 was the worst possible pain)
Time frame: postoperative day (POD) 90
Score of satisfaction with analgesia
At 72 hours after the intervention,the participants rated the satisfaction with analgesia.Satisfaction rating scale 0-5,where 0 was poor drug effectiveness, and 5 was excellent drug efficacy)
Time frame: At 72 hours after the intervention
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