A Study Comparing Two Ultrasound-Guided Paravertebral Nerve Block Methods at the Superior Costotransverse Ligament
for Maintaining Stable Blood Pressure During Thoracoscopic Lung Surgery
in Adults Undergoing Lobectomy
Led by Nanjing First Hospital, Nanjing Medical University · Updated on 2025-05-25
168
Participants Needed
1
Research Sites
N/A
Total Duration
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
Research Team
Y
Yajie Xu
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match. Sign up to get personalized trial recommendations delivered to your inbox.
Nanjing First Hospital, Nanjing Medical University
Lead Sponsor
Geriatric Hospital of Nanjing Medical University
Collaborating Sponsor
Who Can Participate
Age: 18Years +
All Genders
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)
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
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
Post-operative Follow-up
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Comparing Two Doses of Norepinephrine Bolus to Treat Low Blood Pressure During Emergency Abdominal Surgery
Study of Carotid Artery Flow Time and IVC Collapsibility to Predict Low Blood Pressure After General Anesthesia in Older Adults Undergoing Planned Surgery
Prediction of Low Blood Pressure After General Anesthesia Using Carotid Artery Ultrasound in Adults with Chronic Liver Disease
Comparing Costotransverse Foramen Block and Thoracic Paravertebral Block for Pain Relief After Lung Cancer Surgery Thoracotomy
Evaluation of EASIX Score as a Predictor of Low Blood Pressure After Anesthesia in Frail Adults Undergoing Elective Non-Cardiac Surgery
Effect of Different Frequencies of Electrical Acupoint Stimulation on Blood Pressure During Anesthesia for TAVR Surgery
A Study on Hemodynamic Changes in Patients Aged 60 and Older
Study of Different Methods to Reduce Anxiety During Anesthesia Induction in Children Aged 2 to 6
Comparing Liposomal and Standard Bupivacaine for Pain Relief After Thoracoscopic Lung Surgery
Study of Preoperative Blood Volume Optimization Using Echocardiography to Reduce Low Blood Pressure After Anesthesia Induction in Adults Undergoing Surgery
Study of Pressure Recording Analytical Method Parameters to Predict Low Cardiac Reserve and Hypotension Risk in Adults Undergoing Major Surgery with Hypertension or Cardiovascular Risks
Have more questions? Get in touch with our team for quick support
Published Research Related To This Trial
Effect of ultrasound-guided superficial versus deep superior costotransverse ligament on haemodynamics during general anaesthesia induction of thoracoscopic lung resection: protocol for a multicentre, double-blind, randomised controlled trial.