Clinical trial NCT06165991: Efficacy and Safety of Liposomal Bupivacaine in Thoracic Paravertebral Nerve Block
Official title: Efficacy and Safety of Liposomal Bupivacaine for Thoracic Paravertebral Nerve Block Combined With Drainage Tube Analgesia for Postoperative Analgesia After Thoracoscopic Lobectomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Thoracic Paravertebral Block
Postoperative Analgesia
Thoracoscopic Lobectomy
Keywords: liposomal bupivacaine(LB)
Thoracic paravertebral nerve block
Postoperative analgesia
thoracoscopic lobectomy
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Numerical Rating Scale (NRS) for pain at rest
timeFrame: 24hour,48hour, 72hour postoperative
Secondary outcomes:
measure: 15 quality of recovery assessments (QoR15)
timeFrame: at 24, 48, and 72 hours after surgery
measure: area under the NRS score curve (AUC) for resting and exercise
timeFrame: 72 hours after surgery
measure: cumulative opioid consumption (morphine milligram equivalent, MME
timeFrame: at 72 hours after surgery
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
state: Shandong
Study officials:
affiliation: Shandong First Medical University
name: Sun Y tao, PH.D
role: STUDY_CHAIR
References: