Efficacy and Safety of Liposomal Bupivacaine in Thoracic Paravertebral Nerve Block

Efficacy and Safety of Liposomal Bupivacaine for Thoracic Paravertebral Nerve Block Combined With Drainage Tube Analgesia for Postoperative Analgesia After Thoracoscopic Lobectomy

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

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Analgesia; Thoracic Paravertebral Block; Thoracoscopic Lobectomy
• Intervention / Treatment: Drug: Liposomal bupivacaine, 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 Type: Interventional
• Enrollment (Estimated): 228
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: yong T Sun, PH.D; Phone Number: 18660795201; Email: sunyongtao1979@163.com
• Study Contact Backup: Name: jian bo Wu, PH.D; Phone Number: 18560083793; Email: jianbowu@126.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250014
      • Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
      • Contact: yong T Sun, PH.D; Phone Number: 18660795201; Email: sunyongtao1979@163.com
      • Contact: yong T Sun; Phone Number: 18660795201; Email: sunyongtao1979@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A: Bupivacaine; Group A: Participants were treated with 0.5% bupivacaine 20mL thoracic paraverteal block combined with Patient-controlled intravenous analgesia (PCIA) analgesia;	Drug: Liposomal bupivacaine, Bupivacaine; 1.33% (liposomal bupivacaine, LB) 20mL thoracic paravertebral nerve block complex PCIA; 1.33% (liposomal bupivacaine, LB) 20mL thoracic paravertebral nerve block combined with drainage tube analgesia technique combined with PCIA; Other Names: liposomal bupivacaine; drainage tube analgesia technique
Active Comparator: Group B: Bupivacaine with drainage tube; Group B: 0.5% bupivacaine 20mL thoracic paravertebral nerve block combined with drainage tube analgesia technique combined with PCIA;	Drug: Liposomal bupivacaine, Bupivacaine; 1.33% (liposomal bupivacaine, LB) 20mL thoracic paravertebral nerve block complex PCIA; 1.33% (liposomal bupivacaine, LB) 20mL thoracic paravertebral nerve block combined with drainage tube analgesia technique combined with PCIA; Other Names: liposomal bupivacaine; drainage tube analgesia technique
Experimental: Group C: Liposomal bupivacaine; Group C: 1.33% liposomal bupivacaine 20mL thoracic paravertebral nerve block complex PCIA;	Drug: Liposomal bupivacaine, Bupivacaine; 1.33% (liposomal bupivacaine, LB) 20mL thoracic paravertebral nerve block complex PCIA; 1.33% (liposomal bupivacaine, LB) 20mL thoracic paravertebral nerve block combined with drainage tube analgesia technique combined with PCIA; Other Names: liposomal bupivacaine; drainage tube analgesia technique
Experimental: Group D: Liposomal bupivacaine with drainage tube; Group D: 1.33% liposomal bupivacaine 20mL thoracic paravertebral nerve block combined with drainage tube analgesia technique combined with PCIA.	Drug: Liposomal bupivacaine, Bupivacaine; 1.33% (liposomal bupivacaine, LB) 20mL thoracic paravertebral nerve block complex PCIA; 1.33% (liposomal bupivacaine, LB) 20mL thoracic paravertebral nerve block combined with drainage tube analgesia technique combined with PCIA; Other Names: liposomal bupivacaine; drainage tube analgesia technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating Scale (NRS) for pain at rest	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.	24hour,48hour, 72hour postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	at 24, 48, and 72 hours after surgery
area under the NRS score curve (AUC) for resting and exercise	area under the NRS score curve (AUC) for resting and exercise 72 hours after surgery	72 hours after surgery
cumulative opioid consumption (morphine milligram equivalent, MME	cumulative opioid consumption at 72 hours after surgery (morphine milligram equivalent, MME	at 72 hours after surgery

Collaborators and Investigators

• Sponsor: Yongtao Sun
• Investigators: Study Chair: Sun Y tao, PH.D, The First Affiliated Hospital Of Shandong First Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 29, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Actual): December 12, 2023

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Postoperative analgesia; thoracoscopic lobectomy; liposomal bupivacaine(LB); Thoracic paravertebral nerve block
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome; Aortic Dissection; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: liposomal bupivacaine LB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No