An interventional study of Rhombic intercostal nerve block(Received liposomal bupivacaine 93 mg and bupivacaine 25 mg diluted to 20 ml) and Rhombic intercostal nerve block(Receive standard bupivacaine 105 mg diluted to 20 ml with dexamethasone 5 mg.) in Thoracic Surgery, sponsored by Affiliated Hospital of Jiaxing University. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-01.
Sponsored by Affiliated Hospital of Jiaxing University · Not applicable, Interventional, and Treatment
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.
Affiliated Hospital of Jiaxing University is the lead sponsor of 16 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
The nerve block puncture needle was imaged and then entered into the fascial space between the rhomboid and extracostal muscles, and liposomal bupivacaine 93 mg and bupivacaine 25mg diluted to 20 ml were injected into this space.
Procedure: Rhombic intercostal nerve block(Received liposomal bupivacaine 93 mg and bupivacaine 25 mg diluted to 20 ml)
The nerve block puncture needle was imaged and then entered into the fascial space between the rhomboid and external intercostal muscles, and a mixture of: receive standard bupivacaine 105 mg diluted to 20 ml with dexamethasone 5 mg was injected into this space.
Procedure: Rhombic intercostal nerve block(Receive standard bupivacaine 105 mg diluted to 20 ml with dexamethasone 5 mg.)
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.
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.
Area under the curve
Area under the curve of the numeric rating scale (NRS) scores at rest
Time frame: 0-48 hours after surgery
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
Plan to share: No
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Affiliated Hospital of Jiaxing University