Liposomal Bupivacaine in Paravertebral Block for the Treatment of Pain After Video-assisted Thoracoscopic Lobectomy
NCT Number: NCT06569953
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Acute Pain|Chronic Pain|Postoperative Pain
Interventions: DRUG: Liposomal bupivacaine|DRUG: Bupivacaine Hydrochloride
Sponsor: The Second Affiliated Hospital of Chongqing Medical University
Collaborators: People's Hospital of Chongqing|Sichuan Provincial People's Hospital|LanZhou University|Xiangya Hospital of Central South University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 284
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-08-31
Locations: The Second Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, 4000000, China

Summary:
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.

Primary Outcome Measures: Area 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., from 0-72 hours after the intervention|The incidence of chronic postoperative pain, The incidence of chronic postoperative pain at 90 days, postoperative day (POD) 90
Secondary Outcome Measures: Area under the rest pain intensity-time curve, Area under the pain intensity-time curve at rest within 72h after the intervention., 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), 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), 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., 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., from 0-72 hours after the intervention|The time of first use of rescue analgesia, The time of first use of rescue analgesia, from 0-72 hours after the intervention|First time out-of-bed, Time of participant's first out-of-bed activity after surgery, 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, 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), 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), At 72 hours after the intervention