A Phase 3 interventional study of Liposomal bupivacaine and Ropivacaine in Analgesia, sponsored by Feng Gao. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by Feng Gao · Phase 3, Interventional, and Treatment
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,137 are open to participants now.
This study's planned enrollment of 84 is above the median of 75 across 4,341 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Feng Gao is the lead sponsor of 11 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Experimental group will receive PVB with LB 20 mL.
Drug: Liposomal bupivacaine
Comparator group will receive PVB with 20 mL of 0.5% ropivacaine
Drug: Ropivacaine
133mg LB 20mL thoracic paravertebral nerve block
Also known as: Exparel
0.5% ropivacaine 20mL thoracic paravertebral nerve block
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").
Time frame: 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").
Time frame: 24 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").
Time frame: 6 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").
Time frame: 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").
Time frame: 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").
Time frame: 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").
Time frame: 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").
Time frame: 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").
Time frame: 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").
Time frame: 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").
Time frame: 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").
Time frame: 120 hours after surgery
Consumption of analgesic drugs
the amount of analgesic drugs will be recorded
Time frame: 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.
Time frame: 120 hours after surgery
Block duration: first reported pain
Definition: timing begins at block performance
Time frame: 24 hours after surgery
Presence of pain 1 month after surgery assessed using the Brief Pain Inventory.
yes/no
Time frame: 1 month after surgery
Presence of pain 3 months after surgery assessed using the Brief Pain Inventory.
yes/no
Time frame: 3 months after surgery
Presence of pain 6 months after surgery assessed using the Brief Pain Inventory.
yes/no
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: day1 before surgery
Complications within 120hours after surgery
Complications will be recorded.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months after surgery
This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Feng Gao