Efficacy and Safety of Liposomal Bupivacaine Injection for Paravertebral Nerve Block in the Treatment of Acute and Chronic Pain After Thoracoscopic Pneumonectomy: A Multicenter, Randomized, Double-blind, Controlled Clinical Trial

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Second Affiliated Hospital of Chongqing Medical University

About this trial

The goal of this clinical trial is to evaluate the efficacy and safety of liposomal Bupivacaine administered by paravertebral block for the treatment of acute and chronic pain after video-assisted thoracoscopic lobectomy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants who scheduled for elective video-assisted thoracoscopic lobectomy under general anesthesia.

Participants were 18 years or older.

18 kg/m2≤BMI≤30 kg/m2

Participants with American Society of Anesthesiology (ASA) physical status I-III.

Disqualifiers

with severe cardiovascular and cerebrovascular diseases such as myocardial infarction,unstable angina pectoris,severe cardiac rhythm disorders (second- and third-degree heart block,etc.), New York Heart Association (NYHA) functional class III/IV,Ischemic stroke.

with psychiatric disorders (such as schizophrenia,depression,etc.) and cognitive impairment.

with sensory disorders such as hyperalgesia.

with other bodily pain.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Liposomal bupivacaine

    Drug

    Participants randomized to the intervention arm received 266 mg of liposomal bupivacaine for paravertebral block before surgery.(The volume was expanded to 30 mL with normal saline).

  • Bupivacaine Hydrochloride

    Drug

    Participants randomized to the intervention arm received 0.5% 100 mg of bupivacaine hydrochloride for paravertebral block before surgery.(The volume was expanded to 30 mL with normal saline)

Treatment groups

284 Participants
are divided into 2 treatment groups
Group A: intervention (liposomal bupivacaine)Experimental treatment 1 intervention
Group B: control (bupivacaine hydrochloride)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Area under the movement-evoked pain intensity-time curve

Area under the pain intensity-time curve in the movement (or coughing) state within 72h after the intervention.

Time frame
from 0-72 hours after the intervention
2

The incidence of chronic postoperative pain

The incidence of chronic postoperative pain at 90 days

Time frame
postoperative day (POD) 90

Secondary outcomes

1

Area under the rest pain intensity-time curve

Area under the pain intensity-time curve at rest within 72h after the intervention.

Time frame
from 0-72 hours after the intervention
2

Movement-evoked pain score

Use pain Numeric Rating Scale(NRS) to evaluate the movement-evoked pain score at 30minutes after recovery from anesthesia and at 6 hours, 12hours, 24hours , 48hours and 72 hours after the intervention.(NRS scale 0-10, where 0 was no pain, and 10 was the worst possible pain)

Time frame
30 minutes after recovery from anesthesia,6 hours, 12hours, 24hours , 48hours and 72 hours after the intervention
3

Pain score at rest

Use pain Numeric Rating Scale(NRS) to evaluate the pain score at rest at 30minutes after recovery from anesthesia and at 6 hours, 12hours, 24hours , 48hours and 72 hours after the intervention.(NRS scale 0-10, where 0 was no pain, and 10 was the worst possible pain)

Time frame
30 minutes after recovery from anesthesia,6 hours,12hours, 24hours , 48hours and 72 hours after the intervention
4

Proportion of participants who did not use rescue analgesia

Proportion of participants who did not use rescue analgesia during 0-12 hours, 12-24 hours, 24-48 hours, 48-72 hours and 0-72 hours after the intervention.

Time frame
from 0-72 hours after the intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Second Affiliated Hospital of Chongqing Medical University

Lead sponsor

People's Hospital of Chongqing

Collaborator

LanZhou University

Collaborator

Xiangya Hospital of Central South University

Collaborator

Shapingba District People's Hospital of Chongqing

Collaborator