Efficacy and Safety of Liposomal Bupivacaine in Thoracic Paravertebral Nerve Block

Phase 4

Not yet recruiting

• Conditions: Thoracic Paravertebral Block; Postoperative Analgesia; Thoracoscopic Lobectomy
• Interventions: Drug: Liposomal bupivacaine, Bupivacaine

• Registration Number: NCT06165991
• Lead Sponsor: Yongtao Sun

Brief Summary

I. Research purpose

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

1.2 Secondary objective: To investigate the efficacy and safety of drainage tube analgesia after thoracoscopic lobectomy

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

Detailed Description

Group A: Participants were treated with 0.5% bupivacaine 20mL thoracic paravertebral block combined with Patient-controlled intravenous analgesia (PCIA).

Group B: 0.5% bupivacaine 20mL thoracic paravertebral nerve block combined with drainage tube analgesia technique combined with PCIA;

Group C: 1.33% bupivacaine liposome 20mL thoracic paravertebral nerve block complex PCIA;

Group D: 1.33% bupivacaine liposome 20mL thoracic paravertebral nerve block combined with drainage tube analgesia technique combined with PCIA.

A mechanical intravenous analgesic pump (100 mL, Jiangsu Aipeng Medical Technology Co., LTD., Jiangsu, China) was used with no background dose, PCA dose was 1ml, locking interval was 10 minutes, Sufentanil 1ug/kg, Nalbuphine 1mg/kg and ondansetron 16mg, and the postoperative analgesic management system was used to record the number of compressions. Analgesia through the drainage tube was performed by inserting an epidural catheter through the lateral wall of the drainage tube. After the operation, 0.25% bupivacaine 10mL was injected through the epidural catheter. An external mechanical intravenous analgesic pump was installed, and the background dose was set to 5mL/h, without PCA dose. If the NRS score is ≥4 points after 3 consecutive PCA doses, additional rescue drugs are added without limiting the type

Study Timeline

• Study First Submitted: 2023-11-29
• Study First Submitted QC: 2023-12-07
• Study First Posted: 2023-12-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02
• Study Start: 2024-06-01
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 228

Inclusion Criteria

• 1. Age ≥18 years old;

  2. Patients undergoing unilateral initial thoracoscopic lobectomy under general anesthesia (TV or robot-assisted);

  3. American Society of Anesthesiologists (ASA) Grade I - III;

  4. Voluntarily participate in the study and sign the informed consent.

Exclusion Criteria

• 1. Pregnant or lactating women;

  2. Pulmonary wedge-shaped resection;

  3. ≥2 thoracic drainage tubes;

  4. Abnormal liver function: ALT and/or AST>2×ULN, or

TBIL≥1.5×ULN;

5. Renal function impairment (serum creatinine >176μmol/L), or received dialysis treatment within 28 days before surgery;

6. Participate in another research trial involving an investigational drug within 6 months;

7. A history of drug or alcohol abuse;

8. Long-term use of opioids (more than 3 months or more than 5 mg daily morphine equivalent per day for 1 month);

9. History of allergy to local anesthetics or one of the investigational drugs;

10. Uncontrolled mental or neurological symptoms.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C: Liposomal bupivacaine	Liposomal bupivacaine, Bupivacaine	Group C: 1.33% liposomal bupivacaine 20mL thoracic paravertebral nerve block complex PCIA;
Group A: Bupivacaine	Liposomal bupivacaine, Bupivacaine	Group A: Participants were treated with 0.5% bupivacaine 20mL thoracic paraverteal block combined with Patient-controlled intravenous analgesia (PCIA) analgesia;
Group B: Bupivacaine with drainage tube	Liposomal bupivacaine, Bupivacaine	Group B: 0.5% bupivacaine 20mL thoracic paravertebral nerve block combined with drainage tube analgesia technique combined with PCIA;
Group D: Liposomal bupivacaine with drainage tube	Liposomal bupivacaine, Bupivacaine	Group D: 1.33% liposomal bupivacaine 20mL thoracic paravertebral nerve block combined with drainage tube analgesia technique combined with PCIA.

Primary Outcome Measures

Name	Time	Method
Numerical Rating Scale (NRS) for pain at rest	24hour,48hour, 72hour postoperative	Numerical Rating Scale (NRS) for pain at rest for 72h (The average of the three 24h time points: 24, 48, and 72h). The Numeric Pain Scale (NRS) pain numerical score(0-10 score, 0: no pain, 10: worst imaginable pain). A pain measurement list about quiet NRS score at different postoperative time will be used.

Secondary Outcome Measures

Name	Time	Method
15 quality of recovery assessments (QoR15)	at 24, 48, and 72 hours after surgery	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).
area under the NRS score curve (AUC) for resting and exercise	72 hours after surgery	area under the NRS score curve (AUC) for resting and exercise 72 hours after surgery
cumulative opioid consumption (morphine milligram equivalent, MME	at 72 hours after surgery	cumulative opioid consumption at 72 hours after surgery (morphine milligram equivalent, MME

Trial Locations

Locations (1)

Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University; 🇨🇳 Jinan, Shandong, China