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| Name | Class |
|---|---|
| People's Hospital of Chongqing | OTHER |
| LanZhou University | OTHER |
| Xiangya Hospital of Central South University | OTHER |
| Shapingba District People's Hospital of Chongqing |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention (liposomal bupivacaine） | Experimental | Participants randomized to the intervention arm received liposomal bupivacaine for paravertebral block before surgery. |
|
| control (bupivacaine hydrochloride) | Active Comparator | Participants randomized to the intervention arm received bupivacaine hydrochloride for paravertebral block before surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal bupivacaine | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| He Huang, ph.D | Contact | 86+13708385559 | huanghe@cqmu.edu.cn | |
| Guangyou Duan, ph.D | Contact | 86+18323376014 | duangy@hospital.cqmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| He Huang, ph.D | The Second Affiliated Hospital of Chongqing Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | 4000000 | China |
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| UNKNOWN |
Randomization was performed in a 1:1 ratio with the use of block randomization.SAS software (version 9.4 or higher) was used to generate the random number and the treatment group to which the random number was assigned.Assignment of Randomization Numbers Using the Interactive Web Response System (IWRS).
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| Bupivacaine Hydrochloride | Drug | 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) |
|
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 |
| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D059350 | Chronic Pain |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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