Comparison of Bupivacaine Liposomal vs Bupivacaine Combined With Dexamethasone for Postoperative Pain in VATS

Affiliated Hospital of Jiaxing University148 enrolled

Overview

The purpose of this study, is to investigate the effectiveness of ultrasound-guided rhombic intercostal nerve block for postoperative pain control in thoracoscopic pulmonary resection with bupivacaine liposomes versus bupivacaine hydrochloride with dexamethasone to assess whether bupivacaine liposomes will produce analgesia superior to bupivacaine hydrochloride with dexamethasone in terms of analgesia effect and duration of analgesia. This study will also evaluate whether liposomal bupivacaine after nerve block improves the quality of postoperative recovery compared to bupivacaine hydrochloride combined with dexamethasone.

Approved by the Ethics Committee of Jiaxing No. 1 Hospital (approval number: 2024-KY-226). This study was enrolled prior to patient enrollment in the clinical trial. Written informed consent was obtained from all participants. The study is expected to be conducted from April 2024 through December 2025. This study enrolls 90 elective thoracoscopic lung resection surgery(including wedge resection, segmentectomy, or lobectomy) patients between the ages of 18-80 years, ASA Physical Status I and III, who had no allergic reaction to the study drug. Basic monitoring such as electrocardiogram, pulse oximetry, and noninvasive blood pressure were arranged preoperatively. The bupivacaine liposome group was treated with bupivacaine liposome 93 mg combined with bupivacaine 25 mg, and the standard control group was treated with bupivacaine hydrochloride 105 mg combined with dexamethasone 5 mg, and both groups were perfused with saline 20 ml. ultrasound-guided rhombic intercostal muscle nerve block was performed for a total of 20 ml. postoperative analgesia was provided using patient-controlled intravenous analgesia (PCIA), and according to the patients weight and baseline condition. Upon arrival of postoperative patients to the ward, if the patient reports significant pain, defined as the numeric rating scale (NRS), score greater than 3, the first step is to administer one press of the analgesic pump. If the pain persists, the pain management protocol will be initiated. Cumulative PCIA consumption at different postoperative time intervals (including 0-24 hours, 24-48 hours, and 48-72 hours). Quality of Recovery Score (QoR-15) at 72 hours postoperatively, If NRS at 6 hours to 3 months, and patient satisfaction were recorded.Pain assessments were performed at the following time points: 0 hours postoperatively (upon tracheal extubation and patient awakening), 0.5 hours, 2 hours, 4 hours, 12 hours, 24 hours, 48 hours, and 72 hours. Pain score follow-up by telephone at the third month.

Study Type

Interventions

Rhombic intercostal nerve block(Received liposomal bupivacaine 93 mg and bupivacaine 25 mg diluted to 20 ml)PROCEDURE

The patient was placed in lateral recumbency and placed medial to the medial border of the scapula in the oblique sagittal plane using a line array ultrasound probe to identify ultrasound landmarks, trapezius, obliques, intercostals, pleura, and lungs, The block needle was then entered in-plane at the T5 level, with the margins retracting on insertion, and the nerve block perforating needle was imaged and then inserted into the fascial gap between the trapezius and the external intercostal muscles. Receive liposomal bupivacaine 93 mg and bupivacaine 25 mg diluted to 20ml.

Rhombic intercostal nerve block(Receive standard bupivacaine 105 mg diluted to 20 ml with dexamethasone 5 mg.)PROCEDURE

The patient was placed in lateral recumbency and placed medial to the medial border of the scapula in the oblique sagittal plane using a line array ultrasound probe to identify ultrasound landmarks, trapezius, obliques, intercostals, pleura, and lungs, The block needle was then entered in-plane at the T5 level, with the margins retracting on insertion, and the nerve block perforating needle was imaged and then inserted into the fascial gap between the trapezius and the external intercostal muscles. A mixture of standard bupivacaine 105 mg diluted to 20 ml with dexamethasone 5 mg was received.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: ASA physical status I-III, aged between 18 and 80 years, scheduled for elective thoracoscopic lung resection surgery under general anesthesia with endotracheal intubation (including wedge resection, segmentectomy, or lobectomy) with one or three incisions, expected duration of surgery less than 4 hours, and body mass index (BMI) between 18 and 30 kg/m². Exclusion Criteria: 1. trauma or emergency patients; 2. patients classified as New York Heart Association (NYHA) functional class 3-4; 3. unstable coronary artery disease patients; 4. patients with renal system diseases (estimated glomerular filtration rate \<30 mL/min/1.73 m²); 5. patients with liver system diseases (alanine aminotransferase or aspartate aminotransferase levels exceeding twice the normal value); 6. patients with coagulation disorders, or those who have not discontinued warfarin or novel anticoagulants (such as rivaroxaban, dabigatran) prior to surgery; 7. individuals with a history of alcohol abuse or substance dependence within the past two months; 8. patients with uncontrolled anxiety, schizophrenia, or other psychiatric disorders; 9. pregnant or planning to become pregnant women; 10. individuals with a history of allergy to local anesthetics or investigational drugs. Additionally, patients who refuse to sign the informed consent form will also be excluded; 11. chronic pain syndromes (defined as reflex sympathetic dystrophy or complex regional pain syndrome); 12. chronic opioid use (longer than 3 months or daily morphine equivalents more than 5 mg/day for 1 month).

Outcomes

Primary Outcomes

Area under the curve

Area under the curve of the numeric rating scale (NRS) scores at rest

Time frame: 0-48 hours after surgery

Secondary Outcomes

Change in functional pain using Brief Pain Inventory (BPI)

Compare functional pain using the BPI at baseline, 6 weeks and 3 months. The BPI scale defines pain as follows: Score: 1 - 4 = Mild Pain, Score: 5 - 6 = Moderate Pain, Score: 7 - 10 = Severe Pain.

Time frame: Preoperative day one, 6 weeks after surgery, 3 months after surgery

Change in Quality of Recovery 15 questionnaire

15 questions assessing the quality of recovery, rated on a ten-point scale with a total score ranging from 0 (very poor recovery) to 150 (good recovery)

Time frame: Preoperative day one；Day 1, 2 and 7 after surgery

Change in white blood cell count (WBC)

Compare the change in postoperative WBC from baseline only for participants that have an overnight hospital stay

Time frame: Preoperative day one, day 0, day 1 and day 2 after surgery

Length of hospital stay

The patient post surgical length of stay in the hospital will be compared between treatment groups.

Time frame: perioperatively

Absolute value of Interleukin 1 beta (IL-1b)

Absolute value IL-1b at postoperative day 1 only for participants that have an overnight hospital stay

Time frame: day 1 after surgery

CD3、CD4、CD4/CD8 and CD16+56

Postoperative day 1 CD3, CD4, CD4/CD8 and CD16+56 only for participants who were hospitalised overnight and pathologically had lung cancer

Time frame: Preoperative day one，day 1 after surgery

Absolute value of Interleukin 6 (IL-6)

Absolute value IL-6 at postoperative day 1 only for participants that have an overnight hospital stay

Time frame: day 1 after surgery

C-reactive protein (CRP)

Absolute value C-reactive protein at postoperative day 1 only for participants that have an overnight hospital stay

Time frame: day 1 after surgery

Postoperative chest Pain Score

Average postoperative chest pain scores for the first two postoperative days using numerical rating scale (NRS) pain score. Score range from 0 (no pain) to 10 (worst pain possible).

Time frame: Preoperative day one；Day 1 after surgery; Day 2 after surgery; Day 3 after surgery

postoperative complications

Postoperative complications include arrhythmia, bowel obstruction, atrial fibrillation, and other cardiorespiratory systems.

Time frame: perioperatively

mean arterial pressure

Changes in haemodynamics during surgery

Time frame: Start of surgery to end of surgery

systolic blood pressure

Changes in haemodynamics during surgery

Time frame: Start of surgery to end of surgery

diastolic blood pressure

Changes in haemodynamics during surgery

Time frame: Start of surgery to end of surgery

heart rate

Changes in haemodynamics during surgery

Time frame: Start of surgery to end of surgery

liver function

Transaminases in biochemical indicators

Time frame: perioperatively

kidney function

Creatinine in biochemical indicators

Time frame: perioperatively

Incidence of remedial analgesia

Remedial analgesia was given when the patient's numerical analogue score (NRS) was greater than 3 in the postoperative period

Time frame: perioperatively

Comparison of Bupivacaine Liposomal vs Bupivacaine Combined With Dexamethasone for Postoperative Pain in VATS

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes