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

NCT06405724 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: TJ-IRB202403005
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia

Keywords

paravertebral nerve block; liposomal bupivacaine; video-assisted thoracoscopic surgery

Outcome Measures

Primary Outcomes (2)

• 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").

  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").

  24 hours after surgery

Secondary Outcomes (25)

• pain score at rest

  6 hours after surgery

• pain score during coughing

  6 hours after surgery

• pain score at rest

  48 hours after surgery

• pain score during coughing

  48 hours after surgery

• pain score during coughing

  72 hours after surgery

Study Arms (2)

Drug: Liposomal bupivacaine

EXPERIMENTAL

Experimental group will receive PVB with LB 20 mL.

Drug: Liposomal bupivacaine

Drug:ropivacaine

ACTIVE COMPARATOR

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

Drug: Ropivacaine

Interventions

Liposomal bupivacaine DRUG

133mg LB 20mL thoracic paravertebral nerve block

Also known as: Exparel

Drug: Liposomal bupivacaine

Ropivacaine DRUG

0.5% ropivacaine 20mL thoracic paravertebral nerve block

Drug:ropivacaine

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Feng Gao: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Agnosia

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Feng Gao, Doctor

CONTACT

13971587381; fgao@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 5, 2024
• First Posted: May 8, 2024
• Study Start: May 10, 2024
• Primary Completion: December 21, 2025
• Study Completion: December 21, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

CN (1)