Analgesia
Conditions
Keywords
paravertebral nerve block, liposomal bupivacaine, video-assisted thoracoscopic surgery
Brief summary
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.
Detailed description
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.
Interventions
DRUGLiposomal bupivacaine
133mg LB 20mL thoracic paravertebral nerve block
DRUGRopivacaine
0.5% ropivacaine 20mL thoracic paravertebral nerve block
Sponsors
Feng Gao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-64 years old 2. Elective unilateral thoracoscopic surgery 3. Hospital stay ≥3 days 4. Able to cooperate in completing interviews and scale assessments 5. American Society of Anesthesiologists (ASA) classification I-III 6. Signed informed consent form
Exclusion criteria
1. History of thoracic surgery within the past 6 months 2. Pre-existing history of chronic pain or acute pain in the surgical area 3. Allergy to local anesthetics 4. Contraindications to thoracic paravertebral nerve block 5. Mental disorders, intellectual disabilities, epilepsy, or other neurological conditions 6. Severe heart or lung diseases 7. History of opioid drug abuse or substance abuse 8. Postoperative intubation 9. Recent participation in other clinical studies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain score at rest | 24 hours after surgery | 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). |
| pain score during coughing | 24 hours after surgery | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pain score at rest | 6 hours after surgery | 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). |
| pain score during coughing | 6 hours after surgery | 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). |
| Consumption of analgesic drugs | 120 hours after surgery | the amount of analgesic drugs will be recorded |
| Nerve block related adverse events | 120 hours after surgery | Any adverse event resulting from a nerve block, such as toxicity, allergic reactions, or nerve injuries, will be considered causally related. |
| Block duration: first reported pain | 24 hours after surgery | Definition: timing begins at block performance |
| Presence of pain 1 month after surgery assessed using the Brief Pain Inventory. | 1 month after surgery | yes/no |
| Presence of pain 3 months after surgery assessed using the Brief Pain Inventory. | 3 months after surgery | yes/no |
| Presence of pain 6 months after surgery assessed using the Brief Pain Inventory. | 6 months after surgery | yes/no |
| Hospital Anxiety and Depression Scale, HADS | day1 before surgery | 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. |
| Insomnia Severity Index, ISI | day1 before surgery | 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. |
| Charlson Comorbidity Index, CCI | day1 before surgery | 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. |
| Mini-cog | day1 before surgery | 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. |
| Complications within 120hours after surgery | Five days after surgery | Complications will be recorded. |
| The douleur neuropathique 4 questionnaire(DN4) | day1 before surgery | 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. |
Countries
China
Contacts
Primary ContactFeng Gao, Doctor
Outcome results
None listed