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

NCT ID: NCT06405724

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-10

Study Completion Date

2025-12-21

Brief Summary

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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

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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.

Conditions

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Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Drug: Liposomal bupivacaine

Experimental group will receive PVB with LB 20 mL.

Group Type EXPERIMENTAL

Liposomal bupivacaine

Intervention Type DRUG

133mg LB 20mL thoracic paravertebral nerve block

Drug:ropivacaine

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

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

0.5% ropivacaine 20mL thoracic paravertebral nerve block

Interventions

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Liposomal bupivacaine

133mg LB 20mL thoracic paravertebral nerve block

Intervention Type DRUG

Ropivacaine

0.5% ropivacaine 20mL thoracic paravertebral nerve block

Intervention Type DRUG

Other Intervention Names

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Exparel

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Feng Gao

OTHER

Sponsor Role lead

Responsible Party

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Feng Gao

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Tongji Hospital

Wuhan, Hubei, China

Site Status

Countries

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China

Central Contacts

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Feng Gao, Doctor

Role: CONTACT

13971587381 ext. 86

Other Identifiers

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TJ-IRB202403005

Identifier Type: -

Identifier Source: org_study_id

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