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

Thoracic Surgery Clinical Trial

Official title:

Effect of Ultrasound-guided Rhombic Intercostal Nerve Block With Liposomal Bupivacaine Versus Bupivacaine Hydrochloride Combined With Dexamethasone in Thoracoscopic Pneumonectomy on Postoperative Pain: a Non-inferiority Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06392191
• Other study ID #: 2024-KY-226
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2024
• Est. completion date: May 5, 2025

Study information

• Verified date: April 2024
• Source: Affiliated Hospital of Jiaxing University
• Contact: Qinghe ZHOU, professor
• Phone: 13732573379
• Email: jxxmxy[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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 130 thoracoscopic pneumonectomy patients between the ages of 18-80 years, ASA Physical Status I and III, who underwent elective or limited partial pneumonectomy and 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 133 mg combined with bupivacaine 25 mg, and the standard control group was treated with 0.5% bupivacaine hydrochloride 75 mg combined with dexamethasone 5 mg, and both groups were perfused with saline 30 ml. ultrasound-guided rhombic intercostal muscle nerve block was performed for a total of 30 ml. postoperative analgesia was provided using patient-controlled intravenous analgesia (PCIA), and according to the patient's weight and baseline condition, flurbiprofenac 50 mg or tramadol 100 mg rescue analgesia was given every 6 hours when resting VAS score was ≥4. Record cumulative consumption at 72 hours postoperatively. Quality of Recovery Score (QoR-15) at 72 hours postoperatively, Numeric Pain Rating Scale (NRS) at 6 hours to 3 months, and patient satisfaction were recorded.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: May 5, 2025
• Est. primary completion date: May 5, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. American Society of Anesthesiologists status I, II and III; 2.Thoracoscopic pneumonectomy

Exclusion Criteria:

1. Refusal of consent

2. Pregnancy

3. Conditions making the patient unable to fill out questionnaire online, through email or over the phone including with cognitive dysfunction, psychiatric disorder, or non-English speaking patients, or lack of internet access which would prevent post discharge follow-up electronically

4. Coagulopathy

5. Allergy to or for any other reasons cannot use local anesthetic bupivacaine, DEX

6. Insulin dependent or uncontrolled diabetes defined as, day of surgery finger stick glucose >200mg/dl, or HbA1C > 8.0%

7. Peripheral Nerve Block site or systemic infection

8. Immune compromise (e.g., HIV, chronic glucocorticoid use)

9. Severe pre-existing neuropathy

10. Severe hepatic or renal dysfunction (GFR <50 ml/min)

11. Actual body weight <60 kg

12. Patients with active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and non-specific ulcerative colitis

Related Conditions & MeSH terms

• Pain, Postoperative
• Thoracic Surgery

Intervention

Procedure:
• Rhombic intercostal nerve block(Received liposomal bupivacaine 10 ml 133 mg and 0.5% bupivacaine 5 ml diluted to 30 ml)
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 10 ml 133 mg and 0.5% bupivacaine 5 ml diluted to 30 ml.
• Rhombic intercostal nerve block(Receive 0.5% standard bupivacaine 15 ml diluted to 30 ml with dexamethasone 4 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. A mixture of 0.5% standard bupivacaine 15 ml diluted to 30 ml with dexamethasone 4 mg was received.

Locations

Country	Name	City	State
China	The First Hospital of Jiaxing	Jiaxing	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Jiaxing University

Country where clinical trial is conducted

China, 

References & Publications (2)

Elsharkawy H, Ince I, Pawa A. Rhomboid intercostal and sub-serratus (RISS) plane block for analgesia after lung transplant. J Clin Anesth. 2019 Sep;56:85-87. doi: 10.1016/j.jclinane.2019.01.042. Epub 2019 Jan 28. No abstract available. — View Citation

Xie Y, Yan D, Shen J. Video-assisted thoracic surgery versus thoracotomy for treatment of patients with pulmonary sequestration: A systematic review and meta-analysis. Asian J Surg. 2023 Aug;46(8):3387-3388. doi: 10.1016/j.asjsur.2023.03.097. Epub 2023 Ma — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve	Area under the curve of the pain score at rest	0-48 hours after surgery
Secondary	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.	Preoperative day one, 6 weeks after surgery, 3 months after surgery
Secondary	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)	Day 1, 2 and 7 after surgery
Secondary	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).	Day 1 after surgery and Day 2 after surgery
Secondary	Change in white blood cell count (WBC)	Compare the change in postoperative WBC from baseline only for participants that have an overnight hospital stay	Preoperative day one, day 0, day 1 and day 2 after surgery
Secondary	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	day 1 after surgery
Secondary	Length of hospital stay	The patient's post surgical length of stay in the hospital will be compared between treatment groups.	from the start of the surgery to discharge from hospital