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

NCT06841822 | Recruiting DMC

• 2 other identifiers: KY20240924-03-KS-01ZKX21038
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine whether performing a paravertebral nerve block at the superficial surface of the superior costotransverse ligament (SCTL) (without needle penetration of the SCTL) is more effective in maintaining hemodynamic stability during the induction phase of thoracoscopic lung lobectomy compared to the deep surface of the SCTL (with needle penetration of the SCTL). This is a multicenter, double-blind, randomized controlled trial enrolling a total of 168 participants across five hospitals. To investigate the effects of different nerve block methods on hemodynamics during induction, participants will be allocated to either the deep plane SCTL block group (T group) or the superficial plane SCTL block group (S group) using a stratified randomization scheme. The stratification accounts for a 40% proportion of hypertensive patients within each treatment group at each center. Thirty minutes before surgery, patients will receive either an ultrasound-guided deep SCTL block (needle penetrating the SCTL) or a superficial SCTL block (needle not penetrating the SCTL) in the pre-anesthesia room. The target vertebral levels for the block are T4 and T6, and 20 mL of 0.375% ropivacaine hydrochloride solution will be injected slowly at each site. Researchers will document whether subpleural compression is observed on ultrasound imaging and monitor for complications such as hemothorax, pneumothorax, local hematoma, local anesthetic toxicity, epidural anesthesia, or total spinal anesthesia during the procedure. Another investigator, blinded to the group allocation, will evaluate patients after the nerve block procedure, recording any occurrences of hemothorax, pneumothorax, local hematoma, local anesthetic toxicity, epidural block, or total spinal anesthesia. Cold sensitivity tests using the temperature method will be conducted at the midaxillary line within the corresponding blocked regions at 5, 10, 20, and 30 minutes post-block, and the sensory blockade level will be recorded. Thirty minutes after the block, anesthesia induction will be performed using target-controlled infusion (TCI) of propofol and remifentanil, along with rocuronium (0.6 mg/kg). Heart rate (HR), mean arterial pressure (MAP), stroke volume (SV), cardiac index (CI), and stroke volume index (SVI) will be measured every minute from induction until 5 minutes after intubation. Hypotension is defined as a MAP decrease of 20% or an absolute MAP \< 65 mmHg, while severe hypotension is defined as a MAP decrease of 30% or an absolute MAP \< 55 mmHg. Hemodynamic stability will be maintained using vasoactive medications as needed. The study will record intraoperative consumption of propofol and remifentanil, anesthesia duration, intraoperative intravenous fluid volume, urine output, blood loss, and extubation time. Postoperative assessments will include resting and movement-evoked (coughing) VAS scores at 4 and 24 hours, opioid consumption within 24 hours (oxycodone usage, first demand time, number of effective and actual demands), and additional analgesic requirements. The QOR-15 score at 24 hours and puncture-related complications within 72 hours postoperatively will be documented, along with a patient satisfaction survey at 72 hours. For the imaging study evaluating drug diffusion following each block method using CT (3D) imaging, 40 patients will be recruited at Nanjing First Hospital. Patients requiring preoperative CT-guided localization and puncture will receive an ultrasound-guided deep SCTL block (T group) or superficial SCTL block (S group) 30 minutes before the procedure, with 10 patients in each group. The block sites will be at the surgical side T4 and T6 levels, using 20 mL of a nerve block solution containing 0.375% ropivacaine mixed with 2 mL of iohexol (total 20 mL). Following the nerve block, patients will be placed in the supine position, and after 30 minutes, a blinded investigator will assess sensory loss using cold stimulation at the anterior chest wall (midclavicular line), lateral chest wall (posterior axillary line), and posterior chest wall (paravertebral region). Subsequently, patients will undergo routine CT-guided lesion localization and 3D imaging technology will be used to evaluate drug diffusion patterns for the two block techniques. Any adverse events occurring during the trial will be managed according to the study protocol and recorded accordingly.

Conditions

Thoracic Paravertebral Block; Anesthesia Induction; Hypotension on Induction

Outcome Measures

Primary Outcomes (1)

• Incidence of hypotension

  Incidence of hypotension during the induction period of general anesthesia (from the beginning of induction to 5 minutes after induction).Definition of hypotension: a 20% decrease in MAP or a MAP absolute value \< 65 mmHg during this period.

  From the beginning of induction to 5 minutes after induction

Secondary Outcomes (19)

• Incidence of severe hypotension

  From the beginning of induction to 5 minutes after induction

• VAS scores

  4 and 24 hours after surgery

• HR values

  Intraoperative

• MAP values

  Intraoperative

• SV values

  Intraoperative

Study Arms (2)

SCTL superficial plane block group (S group)

EXPERIMENTAL

The puncture needle did not break through SCTL when the ultrasound-guided thoracic paravertebral block was performed.

Other: SCTL superficial plane block

SCTL deep plane block group (T group)

PLACEBO COMPARATOR

SCTL was broken by a puncture needle during the ultrasound-guided thoracic paravertebral block.

Other: SCTL deep plane block group

Interventions

SCTL superficial plane block OTHER

The purpose of this study was to evaluate whether thoracic paravertebral nerve block performed on superficial SCTL (puncture needle did not break SCTL) was more beneficial to maintaining hemodynamic stability during the induction period of thoracoscopic lobectomy compared with SCTL deep plane (puncture needle break SCTL). We performed an ultrasound-guided paravertebral nerve block while keeping the puncture needle did nit to break through the SCTL. In 20 patients who required CT (3D) imaging to observe drug diffusion 30min after nerve block, cold stimulation was used 30min after the procedure to assess the degree of sensory loss, including the anterior chest wall (midclavian line), lateral chest wall (posterior axillary line), and posterior chest wall (paravertebral area).

SCTL superficial plane block group (S group)

SCTL deep plane block group OTHER

Ultrasound-guided thoracic paravertebral nerve block was routinely performed. SCTL was broken by a puncture needle during the ultrasound-guided thoracic paravertebral block. In 20 patients who required CT (3D) imaging to observe drug diffusion 30min after nerve block, cold stimulation was used 30min after the procedure to assess the degree of sensory loss, including the anterior chest wall (midclavian line), lateral chest wall (posterior axillary line), and posterior chest wall (paravertebral area).

SCTL deep plane block group (T group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for elective two-port video-assisted thoracoscopic lobectomy
• Age: ≥18 years
• ASA classification: I-III
• BMI: 18-30 kg/m²

You may not qualify if:

• Severe hypertension (SBP ≥180 mmHg or DBP ≥110 mmHg)
• MAP \<70 mmHg before anesthesia induction
• Emergency surgery
• Severe cardiovascular disease, including history of 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 and kidney dysfunction
• Neurological disorders, spinal disease (deformity or trauma), history of spinal surgery, or abnormal skin sensation in the thoracic or back region
• Existing or anticipated difficult airway management

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead
• Geriatric Hospital of Nanjing Medical University: collaborator
• Dushu Lake Hospital Affiliated to Soochow University: collaborator
• Huai'an First People's Hospital: collaborator
• Yancheng First People's Hospital: collaborator

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

RECRUITING

Study Officials

• Xiaoliang Wang

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

Yajie Xu

CONTACT

86 18651815258; xuyajiechina@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 24, 2025
• Study Start: May 25, 2025
• Primary Completion (Estimated): June 25, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)