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Liposomal and Standard Bupivacaine in Thoracic Paravertebral Block for Post-Thoracoscopic Pain

ConditionsThoracic Paravertebral BlockPostoperative AnalgesiaThoracoscopic Lobectomy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorYongtao Sun

About this trial

I. Research purpose

1.1 Main Objective: To investigate the efficacy and safety of bupivacaine liposome thoracic paravertebral nerve block for postoperative analgesia after thoracoscopic lobectomy

1.2 Exploratory Objective: To investigate the noninferiority of bupivacaine liposomes in thoracic paravertebral nerve block with standard bupivacaine

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1) Age ≥18 years old;

Disqualifiers

1) Pregnant or lactating women;

Trial design

Design model

Parallel

Treatments tested in this trial

  • GroupB:Liposomal bupivacaine and bupivacaine hydrochloride;

    Drug

    Group B::Patients in the intervention group received a mixture of 10 mL of 1.33% liposomal bupivacaine (133 mg) and 10 mL of 0.5% bupivacaine hydrochloride.

  • Group A: bupivacaine hydrochloride;

    Drug

    Group A:Patients in the control group received 20 mL of 0.5% bupivacaine hydrochloride (total dose, 100 mg).

Treatment groups

496 Participants
are divided into 2 treatment groups
Group A: Group A: bupivacaine hydrochlorideActive comparator 1 intervention
Group B: Group B: liposomal bupivacaine and bupivacaine hydrochlorideExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

area under the NRS score curve (AUC) for resting

area under the NRS score curve (AUC) for resting and active 48 hours after surgery

Time frame
48hours postoperative

Secondary outcomes

1

15 quality of recovery assessments (QoR15)

15 quality of recovery assessments (QoR15) at 24, 48, and 72 hours after surgery. Its scores range from 0 to 150, with higher scores indicating better recovery.Based on the scores, QoR can be classified into excellent (QoR-15 \> 135), good (122 ≤ QoR-15 ≤ 135), moderate (90 ≤ QoR-15 ≤ 121), and poor (QoR-15 \<90).

Time frame
at 24, 48, and 72 hours after surgery
2

area under the NRS score curve (AUC) for exercise

area under the NRS score curve (AUC) for resting and exercise 48 hours after surgery

Time frame
48 hours after surgery
3

area under the NRS score curve (AUC) for resting and exercise

area under the NRS score curve (AUC) for exercise 72 hours after surgery

Time frame
72 hours after surgery
4

area under the NRS score curve (AUC) for resting and exercise

area under the NRS score curve (AUC) for resting and exercise 96 hours after surgery

Time frame
96 hours after surgery

Other outcomes

Sponsors and contacts

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

Yongtao Sun

Lead sponsor

Qianfoshan Hospital

Sponsor institution

Source ClinicalTrials.gov
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