Clinical trial NCT06405724: Comparison of the Ultrasound-guided Paravertebral Nerve Block With Liposomal Bupivacaine Versus Ropivacaine for Post-Surgical Pain After Video-Assisted Thoracoscopic Surgery
Official title: Comparison of the Ultrasound-guided Paravertebral Nerve Block With Liposomal Bupivacaine Versus Ropivacaine for Post-Surgical Pain After Video-Assisted Thoracoscopic Surgery:A Single-Center, Prospective, Randomized, and Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Analgesia
Keywords: paravertebral nerve block
liposomal bupivacaine
video-assisted thoracoscopic surgery
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: pain score at rest
timeFrame: 24 hours after surgery
measure: pain score during coughing
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: pain score at rest
timeFrame: 6 hours after surgery
measure: pain score during coughing
timeFrame: 6 hours after surgery
measure: pain score at rest
timeFrame: 48 hours after surgery
measure: pain score during coughing
timeFrame: 48 hours after surgery
measure: pain score during coughing
timeFrame: 72 hours after surgery
measure: pain score at rest
timeFrame: 72 hours after surgery
measure: pain score at rest
timeFrame: 96 hours after surgery
measure: pain score during coughing
timeFrame: 96 hours after surgery
measure: pain score at rest
timeFrame: 120 hours after surgery
measure: pain score during coughing
timeFrame: 120 hours after surgery
measure: Consumption of analgesic drugs
timeFrame: 120 hours after surgery
measure: Nerve block related adverse events
timeFrame: 120 hours after surgery
measure: Block duration: first reported pain
timeFrame: 24 hours after surgery
measure: Presence of pain 1 month after surgery assessed using the Brief Pain Inventory.
timeFrame: 1 month after surgery
measure: Presence of pain 3 months after surgery assessed using the Brief Pain Inventory.
timeFrame: 3 months after surgery
measure: Presence of pain 6 months after surgery assessed using the Brief Pain Inventory.
timeFrame: 6 months after surgery
measure: Hospital Anxiety and Depression Scale, HADS
timeFrame: day1 before surgery
measure: Insomnia Severity Index, ISI
timeFrame: day1 before surgery
measure: Charlson Comorbidity Index, CCI
timeFrame: day1 before surgery
measure: Mini-cog
timeFrame: day1 before surgery
measure: Complications within 120hours after surgery
timeFrame: Five days after surgery
measure: The douleur neuropathique 4 questionnaire(DN4)
timeFrame: day1 before surgery
measure: The douleur neuropathique 4 questionnaire(DN4)
timeFrame: 1 month after surgery
measure: The douleur neuropathique 4 questionnaire(DN4)
timeFrame: 3 months after surgery
measure: The douleur neuropathique 4 questionnaire(DN4)
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
References: