Comparison of the Ultrasound-guided Paravertebral Nerve Block With Liposomal Bupivacaine Versus Ropivacaine for Post-Surgical Pain After Video-Assisted Thoracoscopic Surgery
- Conditions
- Analgesia
- Interventions
- Registration Number
- NCT06405724
- Lead Sponsor
- Feng Gao
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 84
- Age 18-64 years old
- Elective unilateral thoracoscopic surgery
- Hospital stay ≥3 days
- Able to cooperate in completing interviews and scale assessments
- American Society of Anesthesiologists (ASA) classification I-III
- Signed informed consent form
- History of thoracic surgery within the past 6 months
- Pre-existing history of chronic pain or acute pain in the surgical area
- Allergy to local anesthetics
- Contraindications to thoracic paravertebral nerve block
- Mental disorders, intellectual disabilities, epilepsy, or other neurological conditions
- Severe heart or lung diseases
- History of opioid drug abuse or substance abuse
- Postoperative intubation
- Recent participation in other clinical studies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Drug: Liposomal bupivacaine Liposomal bupivacaine Experimental group will receive PVB with LB 20 mL. Drug:ropivacaine Ropivacaine Comparator group will receive PVB with 20 mL of 0.5% ropivacaine
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method pain score during coughing 120 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").
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.
Presence of pain 3 months after surgery assessed using the Brief Pain Inventory. 3 months after surgery yes/no
pain score at rest 120 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").
Consumption of analgesic drugs 120 hours after surgery the amount of analgesic drugs will be recorded
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 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.
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.
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.
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.
Complications within 120hours after surgery Five days after surgery Complications will be recorded.
The douleur neuropathique 4 questionnaire(DN4) 6 months after 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.
Trial Locations
- Locations (1)
Tongji Hospital
🇨🇳Wuhan, Hubei, China