Comparison of the Ultrasound-guided Paravertebral Nerve Block With Liposomal Bupivacaine Versus Ropivacaine for Post-Surgical Pain After Video-Assisted Thoracoscopic Surgery

Feng Gao

Status and phase: Not yet enrolling; Phase 3

Conditions: Analgesia

Treatments: Drug: Liposomal bupivacaine; Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT06405724

TJ-IRB202403005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 2 patient groups

Drug: Liposomal bupivacaine

Experimental group

Description:

Experimental group will receive PVB with LB 20 mL.

Treatment:

Drug: Liposomal bupivacaine

Drug:ropivacaine

Active Comparator group

Description:

Comparator group will receive PVB with 20 mL of 0.5% ropivacaine

Treatment:

Drug: Ropivacaine