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Prospective, randomized, and controlled trial to compare the postoperative pain management of paravertebral nerve block with liposomal bupivacaine to ropivacaine in patients undergoing elective thoracoscopic surgery.
The objective of this study is to validate the analgesic efficacy of liposomal bupivacaine (LB) compared with ropivacaine when injected for paravertebral nerve block (PVB) for video-assisted thoracoscopic surgery (VATS).
We hypothesize that LB will be superior to ropivacaine in terms of postoperative pain control following VATS. The primary outcome of this study will be NRS pain scores for resting pain and NRS pain scores for cough pain 24 hours following surgery. Secondary outcomes will include pain scores over the first 120 hours following surgery, opioid consumption, opioid-related adverse events, block-related adverse events, time of first getting out of bed, catheter indwelling time, postoperative hospitalization time, patient satisfaction, and chronic pain at 1, 3, and 6 months after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug: Liposomal bupivacaine | Experimental | Experimental group will receive PVB with LB 20 mL. |
|
| Drug:ropivacaine | Active Comparator | Comparator group will receive PVB with 20 mL of 0.5% ropivacaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal bupivacaine | Drug | 133mg LB 20mL thoracic paravertebral nerve block |
|
| Measure | Description | Time Frame |
|---|---|---|
| pain score at rest | The pain score at rest will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain"). | 24 hours after surgery |
| pain score during coughing | The pain score during coughing will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain"). | 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| pain score at rest | The pain score at rest will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain"). | 6 hours after surgery |
| pain score during coughing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng Gao, Doctor | Contact | 13971587381 | 86 | fgao@tjh.tjmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital | Wuhan | Hubei | 430030 | China |
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| Ropivacaine | Drug | 0.5% ropivacaine 20mL thoracic paravertebral nerve block |
|
The pain score during coughing will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain").
| 6 hours after surgery |
| pain score at rest | The pain score at rest will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain"). | 48 hours after surgery |
| pain score during coughing | The pain score during coughing will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain"). | 48 hours after surgery |
| pain score during coughing | The pain score during coughing will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain"). | 72 hours after surgery |
| pain score at rest | The pain score at rest will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain"). | 72 hours after surgery |
| pain score at rest | The pain score at rest will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain"). | 96 hours after surgery |
| pain score during coughing | The pain score during coughing will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain"). | 96 hours after surgery |
| pain score at rest | The pain score at rest will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain"). | 120 hours after surgery |
| pain score during coughing | The pain score during coughing will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 (representing "no pain") to 10 (representing "the worst pain"). | 120 hours after surgery |
| Consumption of analgesic drugs | the amount of analgesic drugs will be recorded | 120 hours after surgery |
| Nerve block related adverse events | Any adverse event resulting from a nerve block, such as toxicity, allergic reactions, or nerve injuries, will be considered causally related. | 120 hours after surgery |
| Block duration: first reported pain | Definition: timing begins at block performance | 24 hours after surgery |
| Presence of pain 1 month after surgery assessed using the Brief Pain Inventory. | yes/no | 1 month after surgery |
| Presence of pain 3 months after surgery assessed using the Brief Pain Inventory. | yes/no | 3 months after surgery |
| Presence of pain 6 months after surgery assessed using the Brief Pain Inventory. | yes/no | 6 months after surgery |
| Hospital Anxiety and Depression Scale, HADS | The Hospital Anxiety and Depression Scale (HADS) is primarily used to screen for anxiety and depression in general hospital patients. The HADS includes a total of 14 items, with 7 items assessing depression and 7 items assessing anxiety. There are six reverse question entries, five on the depression subscale and one on the anxiety subscale. | day1 before surgery |
| Insomnia Severity Index, ISI | The Insomnia Severity Index (ISI) is a self-assessment tool for self-perception of insomnia symptoms in the past two weeks. It includes 7 items, with each item scoring 0 to 4 points. The questions involve the subject's subjective evaluation of sleep quality, including the severity of symptoms and their satisfaction with their sleep patterns. The impact of insomnia on daily functioning, the subject's awareness of the impact of insomnia on themselves, and the level of depression caused by sleep disorders. | day1 before surgery |
| Charlson Comorbidity Index, CCI | The Charlson Comorbidity Index (CCI) is a commonly used evaluation method in clinical research to assess the health status of patients and predict their life expectancy by scoring coexisting diseases and age. | day1 before surgery |
| Mini-cog | The Mini-Cog uses recall and clock-drawing tests to determine whether patients have cognitive impairments. A score of 0-2 indicates a positive dementia screening, while a score of 3-5 implies a negative screening, necessitating further evaluation. | day1 before surgery |
| Complications within 120hours after surgery | Complications will be recorded. | Five days after surgery |
| The douleur neuropathique 4 questionnaire(DN4) | This questionnaire serves as a diagnostic tool for identifying neuropathic pain. It comprises 10 options, consisting of 7 self-assessment items that evaluate symptoms. The total score is 10 points, and a score of ≥ 4 indicates the possibility of neuropathic pain, while a score < 4 rules out neuropathic pain. | day1 before surgery |
| The douleur neuropathique 4 questionnaire(DN4) | This questionnaire serves as a diagnostic tool for identifying neuropathic pain. It comprises 10 options, consisting of 7 self-assessment items that evaluate symptoms. The total score is 10 points, and a score of ≥ 4 indicates the possibility of neuropathic pain, while a score < 4 rules out neuropathic pain. | 1 month after surgery |
| The douleur neuropathique 4 questionnaire(DN4) | This questionnaire serves as a diagnostic tool for identifying neuropathic pain. It comprises 10 options, consisting of 7 self-assessment items that evaluate symptoms. The total score is 10 points, and a score of ≥ 4 indicates the possibility of neuropathic pain, while a score < 4 rules out neuropathic pain. | 3 months after surgery |
| The douleur neuropathique 4 questionnaire(DN4) | This questionnaire serves as a diagnostic tool for identifying neuropathic pain. It comprises 10 options, consisting of 7 self-assessment items that evaluate symptoms. The total score is 10 points, and a score of ≥ 4 indicates the possibility of neuropathic pain, while a score < 4 rules out neuropathic pain. | 6 months after surgery |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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