Actively Recruiting
The Impact of Ultrasound-Guided Superficial and Deep Paravertebral Nerve Blocks at the Superior Costotransverse Ligament on Hemodynamics During the Induction Phase of Thoracoscopic Lung Lobectomy: A Multicenter, Double-Blind, Randomized Controlled Trial
Led by Nanjing First Hospital, Nanjing Medical University · Updated on 2025-05-25
168
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
N
Nanjing First Hospital, Nanjing Medical University
Lead Sponsor
G
Geriatric Hospital of Nanjing Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether performing a paravertebral nerve block on the superficial surface of the superior costotransverse ligament (SCTL) without piercing it is more effective in maintaining stable heart and blood pressure levels during anesthesia induction for thoracoscopic lung lobectomy compared to the traditional deep surface approach where the needle penetrates the SCTL. This multicenter, double-blind, randomized controlled trial involves 168 participants across five hospitals, focusing on whether the different nerve block methods affect hemodynamic stability while providing equivalent pain relief. Participants will be randomly assigned to either the deep plane SCTL block group, where the needle penetrates the SCTL, or the superficial plane SCTL block group, where the needle does not penetrate. Both groups receive an ultrasound-guided nerve block 30 minutes before surgery at the T4 and T6 vertebral levels, injecting 20 mL of 0.375% ropivacaine slowly. A subgroup of 40 patients will undergo CT imaging to study drug diffusion patterns after the nerve block. During surgery, anesthesia is induced with propofol, remifentanil, and rocuronium, while researchers monitor heart rate, blood pressure, and other heart function measures. Participants will be closely monitored for complications during and after the nerve block procedure, including pneumothorax, hemothorax, and local anesthetic effects. Sensory blockade is assessed through temperature tests at multiple time points after the block. Researchers track blood pressure stability, drug use during surgery, pain scores up to 24 hours post-surgery, opioid use, and patient satisfaction. Imaging studies will evaluate drug spread in the nerve block area. The trial aims to provide detailed data on hemodynamic effects and safety of the two nerve block techniques throughout the surgical and recovery periods.
CONDITIONS
Brief Title
The Impact of Ultrasound-Guided Superficial and Deep Paravertebral Nerve Blocks at the Superior Costotransverse Ligament on Hemodynamics During the Induction Phase of Thoracoscopic Lung Lobectomy: A Multicenter, Double-Blind, Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients scheduled for elective two-port video-assisted thoracoscopic lobectomy
- Age 18 years or older
- ASA classification I to III
- Body mass index (BMI) between 18 and 30 kg/m²
You will not qualify if you...
- Severe hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg)
- Mean arterial pressure less than 70 mmHg before anesthesia induction
- Emergency surgery
- Severe cardiovascular disease including cerebral or thoracic/abdominal aortic aneurysm
- Congestive heart failure (New York Heart Association class III or IV)
- Untreated or unstable ischemic heart disease
- Severe aortic or mitral valve disease
- Pregnancy or lactation
- Coagulation disorders
- Bacteremia, sepsis, or infection at the puncture site
- Allergy to study-related drugs
- Severe liver or kidney dysfunction
- Neurological disorders, spinal disease, history of spinal surgery, or abnormal skin sensation in the thoracic or back region
- Existing or anticipated difficult airway management
- Other conditions deemed unsuitable for inclusion by investigators
- History of anaphylaxis caused by contrast agents (for those undergoing CT imaging)
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants receive an ultrasound-guided thoracic paravertebral nerve block either at the superficial layer of the superior costotransverse ligament (SCTL) or by puncturing through the SCTL, followed by general anesthesia and thoracoscopic lung lobectomy surgery.
1 baseline visit (pre-surgery) and intraoperative monitoring
Duration - Up to 72 hours after surgery
Participants are monitored for pain levels, complications, and recovery after surgery with assessments including pain scores, puncture-related complications, and satisfaction surveys.
Multiple visits up to 72 hours post-surgery
Trial Site Locations
Total: 1 location
1
Nanjing First Hospital
Nanjing, Jiangsu, China, 210006
Actively Recruiting
Research Team
Y
Yajie Xu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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