Efficacy and Safety of Liposomal Bupivacaine in Thoracic Paravertebral Nerve Block

Postoperative Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06165991
• Other study ID #: liposomal bupivacaine LB
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Qianfoshan Hospital
• Contact: yong t Sun, PH.D
• Phone: 18660795201
• Email: sunyongtao1979[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 228
• Est. completion date: December 31, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Dissection
• Postoperative Analgesia
• Thoracic Paravertebral Block

Intervention

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

Locations

Country	Name	City	State
China	Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Yongtao Sun

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	cumulative opioid consumption (morphine milligram equivalent, MME	cumulative opioid consumption at 72 hours after surgery (morphine milligram equivalent, MME	at 72 hours after surgery