Thoracic Paravertebral BlockNCT06841822
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
A study testing SCTL superficial plane block and SCTL deep plane block group in people with Thoracic Paravertebral Block and Anesthesia Induction, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Paravertebral Block, Anesthesia Induction, Hypotension on Induction
- What is being tested?
- SCTL superficial plane block and SCTL deep plane block group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective two-port video-assisted thoracoscopic lobectomy
- Age: ≥18 years
- ASA classification: I-III
- BMI: 18-30 kg/m²
Who cannot join
- 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
Show all 15Show fewer
- 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
- Other conditions deemed unsuitable for inclusion by the investigators Forty patients who required CT (3D) imaging technology to observe drug diffusion after the implementation of the two methods were included as follows: patients who were scheduled to undergo double-hole thoracoscopic lobectomy, aged ≥18 years, ASA grade I to III, BMI 18 to 30kg/m2, and required preoperative CT localization. Exclusion criteria In addition to the above conditions, patients with a history of anaphylaxis induced by contrast agents should be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210006
Xiaoliang Wang, 86 13776615743, wxl145381@njmu.edu.cn
About this study
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.
Read more
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.
Read the detailed description
Thoracoscopic lobectomy is a commonly performed surgical procedure known for its minimal invasiveness and rapid recovery. Effective pain management during surgery is crucial for patient recovery and surgical outcomes. To further enhance postoperative comfort and accelerate recovery, the combined use of general anesthesia and regional blockade techniques has been increasingly recommended in recent years. Regional blockade not only effectively alleviates postoperative pain but also helps reduce the consumption of general anesthetic agents, facilitating faster recovery.
Thoracic paravertebral block (TPVB) is an effective regional anesthesia technique that provides a novel option for postoperative pain management in thoracoscopic lobectomy. TPVB involves the injection of local anesthetics near the intervertebral foramen adjacent to the thoracic spinal nerves, achieving blockade of the ipsilateral thoracic somatic and sympathetic nerves. It is primarily used for postoperative analgesia in rib fractures, breast surgery, thoracotomy, and thoracoscopic procedures. To ensure the effectiveness of regional blockade and optimize surgical turnover time, TPVB is typically performed in the pre-anesthesia room 30 minutes before surgery. This approach maximizes its analgesic benefits and promotes rapid postoperative recovery.
With the advancement of ultrasound-guided nerve block techniques, the incidence of complications such as pneumothorax and hemothorax associated with TPVB has significantly decreased. However, performing TPVB before surgery not only blocks thoracic nerves but also affects the sympathetic nerves regulating cardiac function. Inhibition of the sympathetic nervous system can lead to reduced myocardial contractility and heart rate, along with decreased peripheral vascular resistance, thereby increasing the incidence of hypotension during general anesthesia induction. This remains a critical clinical issue requiring urgent resolution.
The thoracic paravertebral space is a wedge-shaped space located on both sides of the thoracic vertebrae. Its medial boundary consists of the vertebral body, intervertebral disc, and intervertebral foramen, which connect to the epidural space. The lateral boundary extends to the intercostal space, the anterior boundary is formed by the pleura, and the posterior boundary consists of the superior costal transverse ligament (SCTL). Within this space lie structures such as the intercostal arteries and veins, spinal nerve roots, dorsal branches of spinal nerves, intercostal nerves, communicating branches, sympathetic chain, and adipose tissue.
Costache et al. demonstrated through cadaveric dye injection studies that dye diffused within the thoracic paravertebral space, suggesting that it is not a completely enclosed anatomical compartment and that the SCTL does not act as a diffusion barrier for local anesthetics. Furthermore, Cho TH used micro-CT imaging to confirm that the thoracic paravertebral space is extremely narrow and that the SCTL does not form a closed posterior boundary. This finding indicates that drug injection on the superficial side of the SCTL can also spread into the thoracic paravertebral space.
Compared to conventional TPVB, injecting local anesthetics into the superficial layer of the SCTL allows the drugs to diffuse through the costotransverse ligament into the paravertebral space. With the same volume of local anesthetic, a smaller amount reaches the paravertebral space in a shorter time, resulting in a milder effect and less impact on sympathetic nerves. Theoretically, this approach may reduce the incidence of hypotension.
This study aims to investigate whether performing TPVB at the superficial layer of the SCTL (without puncturing through the ligament) provides more stable hemodynamics during anesthesia induction compared to the conventional deep approach (where the needle penetrates the SCTL), while maintaining equivalent analgesic effects for thoracoscopic lung resection surgery.
- Being tested
- SCTL superficial plane block, SCTL deep plane block group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCTL superficial plane blockOther
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 deep plane block groupOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: SCTL deep plane block group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the beginning of induction to 5 minutes after induction
Secondary outcomes (19)
Incidence of severe hypotension
The incidence of severe hypotension during the induction period of general anesthesia (from the beginning of induction to 5 minutes after induction). Definition of severe hypotension: a 30% decrease in MAP or a MAP absolute value < 55 mmHg.
Measured: From the beginning of induction to 5 minutes after induction
VAS scores
The Visual Analog Scale (VAS) is used for assessing pain intensity. It consists of a continuous 10 cm (or 100 mm) line on which patients indicate their perceived level of pain or another symptom by marking a point along the scale.
VAS Scale Minimum and Maximum Values Minimum value (0 cm or 0 mm): This represents no pain or the least possible intensity of the measured symptom.
Maximum value (10 cm or 100 mm): Represents the worst imaginable pain or the most severe intensity of the measured symptom.
Interpretation of Higher Scores Higher VAS scores indicate worse outcomes, meaning greater pain intensity or more severe symptoms.
Lower VAS scores indicate better outcomes, meaning less pain or milder symptoms.
Common VAS Score Ranges for Pain
Pain levels are often categorized as follows:
0 mm: No pain 1-3 mm: Mild pain 4-6 mm: Moderate pain 7-10 mm: Severe pain
Measured: 4 and 24 hours after surgery
HR values
HR values were recorded before the block, during induction (per minute), and when hypotension occurred.
Measured: Intraoperative
MAP values
MAP values were recorded before the block, during induction (per minute), and when hypotension occurred.
Measured: Intraoperative
SV values
SV values were recorded before the block, during induction (per minute), and when hypotension occurred.
Measured: Intraoperative
CI values
CI values were recorded before the block, during induction (per minute), and when hypotension occurred.
Measured: Intraoperative
Use of vasoactive drugs
Record the use of vasoactive drugs during induction.
Measured: From the beginning of induction to 5 minutes after induction
Use of propofol and remifentanil
The amount of propofol and remifentanil used during operation and anesthesia induction were recorded
Measured: Anesthesia induction and during operation
Surgery duration
Surgery duration was recorded from skin incision to wound closure, measured in minutes.
Measured: Intraoperative
Puncture related adverse events
Records of puncture-related adverse events (whether hemothorax, pneumothorax, local hematoma, local anesthetic poisoning, epidural block, or general spinal anesthesia).
Measured: Recorded during the operation
Score of QOR-15
The QOR-15 score 24 hours after operation was recorded
Measured: 24 hours after surgery
The use of analgesic pump and additional analgesic drugs
The use of analgesic pump (oxycodone dosage, first compression time, effective compression times, actual compression times) and the use of additional analgesic drugs were recorded within 24 hours.
Measured: 24 hours after surgery
Puncture-related complications
The puncture-related complications were observed within 72 hours after the operation.
Measured: 72 hours after surgery
Satisfaction survey
The satisfaction survey of patients was recorded 72 hours after the operation
Measured: 72 hours after surgery
Intraoperative intravenous infusion volume
Intraoperative intravenous (IV) infusion volume refers to the total amount of fluids administered intravenously during surgery.
Measured: Intraoperative
Intraoperative urine volume
Intraoperative urine volume refers to the amount of urine output measured during surgery.
Measured: Intraoperative
Intraoperative blood loss
Typically measured in milliliters (mL). Estimated using: Suction canister volume (after subtracting irrigation fluids). Surgical sponges and gauze weighing (1g weight increase ≈ 1mL blood loss). Visual estimation by the surgical team.
Measured: Intraoperative
Extubation time
Extubation time refers to the time from the end of surgery to the removal of the endotracheal tube after general anesthesia.
Measured: up to 1 hour
CT (3D) imaging
CT (3D) imaging was used to observe drug diffusion 30min after nerve block and cold stimulation was used to assess the degree of sensory loss, including the anterior chest wall (midclavicular line), lateral chest wall (posterior axillary line), and posterior chest wall (paravertebral area).
Measured: 30 minutes after nerve block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start25 May 2025 (estimated)
- Primary completion25 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thoracic Paravertebral BlockStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Geriatric Hospital of Nanjing Medical University, Dushu Lake Hospital Affiliated to Soochow University, Huai'an First People's Hospital, Yancheng First People's Hospital
- Responsible party
- Sponsor
- Investigators
- Xiaoliang Wang, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841822
- Sponsor's protocol ID
- KY20240924-03-KS-01
- Other IDs
- ZKX21038
- Status last verified
- May 2025
- First submitted
- 11 Feb 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In order to protect the privacy of participants, researchers decided not to make the data public. To obtain relevant data, researchers can be contacted if necessary.
Publications
Xu Y, Luo Y, Zhang W, Fang Z, Qiu Z, Yi H, Shi H, Cheng H, Wang X. 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. BMJ Open. 2026 Jul 22;16(7):e115332. doi: 10.1136/bmjopen-2025-115332.
PubMed 42486516
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06841822
- Acronym / sponsor ID
- KY20240924-03-KS-01
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Geriatric Hospital of Nanjing Medical University, Dushu Lake Hospital Affiliated to Soochow University, Huai'an First People's Hospital, Yancheng First People's Hospital
- Study start
- 25 May 2025 (estimated)
- Primary completion
- 25 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Thoracoscopic lobectomy is a commonly performed surgical procedure known for its minimal invasiveness and rapid recovery. Effective pain management during surgery is crucial for patient recovery and surgical outcomes. To further enhance postoperative comfort and accelerate recovery, the combined use of general anesthesia and regional blockade techniques has been increasingly recommended in recent years. Regional blockade not only effectively alleviates postoperative pain but also helps reduce the consumption of general anesthetic agents, facilitating faster recovery.
Thoracic paravertebral block (TPVB) is an effective regional anesthesia technique that provides a novel option for postoperative pain management in thoracoscopic lobectomy. TPVB involves the injection of local anesthetics near the intervertebral foramen adjacent to the thoracic spinal nerves, achieving blockade of the ipsilateral thoracic somatic and sympathetic nerves. It is primarily used for postoperative analgesia in rib fractures, breast surgery, thoracotomy, and thoracoscopic procedures. To ensure the effectiveness of regional blockade and optimize surgical turnover time, TPVB is typically performed in the pre-anesthesia room 30 minutes before surgery. This approach maximizes its analgesic benefits and promotes rapid postoperative recovery.
With the advancement of ultrasound-guided nerve block techniques, the incidence of complications such as pneumothorax and hemothorax associated with TPVB has significantly decreased. However, performing TPVB before surgery not only blocks thoracic nerves but also affects the sympathetic nerves regulating cardiac function. Inhibition of the sympathetic nervous system can lead to reduced myocardial contractility and heart rate, along with decreased peripheral vascular resistance, thereby increasing the incidence of hypotension during general anesthesia induction. This remains a critical clinical issue requiring urgent resolution.
The thoracic paravertebral space is a wedge-shaped space located on both sides of the thoracic vertebrae. Its medial boundary consists of the vertebral body, intervertebral disc, and intervertebral foramen, which connect to the epidural space. The lateral boundary extends to the intercostal space, the anterior boundary is formed by the pleura, and the posterior boundary consists of the superior costal transverse ligament (SCTL). Within this space lie structures such as the intercostal arteries and veins, spinal nerve roots, dorsal branches of spinal nerves, intercostal nerves, communicating branches, sympathetic chain, and adipose tissue.
Costache et al. demonstrated through cadaveric dye injection studies that dye diffused within the thoracic paravertebral space, suggesting that it is not a completely enclosed anatomical compartment and that the SCTL does not act as a diffusion barrier for local anesthetics. Furthermore, Cho TH used micro-CT imaging to confirm that the thoracic paravertebral space is extremely narrow and that the SCTL does not form a closed posterior boundary. This finding indicates that drug injection on the superficial side of the SCTL can also spread into the thoracic paravertebral space.
Compared to conventional TPVB, injecting local anesthetics into the superficial layer of the SCTL allows the drugs to diffuse through the costotransverse ligament into the paravertebral space. With the same volume of local anesthetic, a smaller amount reaches the paravertebral space in a shorter time, resulting in a milder effect and less impact on sympathetic nerves. Theoretically, this approach may reduce the incidence of hypotension.
This study aims to investigate whether performing TPVB at the superficial layer of the SCTL (without puncturing through the ligament) provides more stable hemodynamics during anesthesia induction compared to the conventional deep approach (where the needle penetrates the SCTL), while maintaining equivalent analgesic effects for thoracoscopic lung resection surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCTL superficial plane block group (S group) | Experimental | Other: SCTL superficial plane blockThe puncture needle did not break through SCTL when the ultrasound-guided thoracic paravertebral block was performed. |
| SCTL deep plane block group (T group) | Placebo comparator | Other: SCTL deep plane block groupSCTL was broken by a puncture needle during the ultrasound-guided thoracic paravertebral block. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled for elective two-port video-assisted thoracoscopic lobectomy
- Age: ≥18 years
- ASA classification: I-III
- BMI: 18-30 kg/m²
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCTL superficial plane blockThe 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). | Other | SCTL superficial plane block group (S group) |
| SCTL deep plane block groupUltrasound-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). | Other | SCTL deep plane block group (T group) |
Primary outcome
Incidence of hypotension
Time frame: From the beginning of induction to 5 minutes after induction
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.
19 secondary outcomes
Incidence of severe hypotension
Time frame: From the beginning of induction to 5 minutes after induction
VAS scores
Time frame: 4 and 24 hours after surgery
HR values
Time frame: Intraoperative
MAP values
Time frame: Intraoperative
SV values
Time frame: Intraoperative
CI values
Time frame: Intraoperative
Use of vasoactive drugs
Time frame: From the beginning of induction to 5 minutes after induction
Use of propofol and remifentanil
Time frame: Anesthesia induction and during operation
Surgery duration
Time frame: Intraoperative
Puncture related adverse events
Time frame: Recorded during the operation
Score of QOR-15
Time frame: 24 hours after surgery
The use of analgesic pump and additional analgesic drugs
Time frame: 24 hours after surgery
Puncture-related complications
Time frame: 72 hours after surgery
Satisfaction survey
Time frame: 72 hours after surgery
Intraoperative intravenous infusion volume
Time frame: Intraoperative
Intraoperative urine volume
Time frame: Intraoperative
Intraoperative blood loss
Time frame: Intraoperative
Extubation time
Time frame: up to 1 hour
CT (3D) imaging
Time frame: 30 minutes after nerve block
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Derived from this study: PubMed 42486516Xu Y, Luo Y, Zhang W, Fang Z, Qiu Z, Yi H, Shi H, Cheng H, Wang X. 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. BMJ Open. 2026 Jul 22;16(7):e115332. doi: 10.1136/bmjopen-2025-115332.
- Individual participant dataSharing planned: No. In order to protect the privacy of participants, researchers decided not to make the data public. To obtain relevant data, researchers can be contacted if necessary.
Related trials for Thoracic Paravertebral Block
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Comparison of Analgesic Efficacy Between Ultrasound Guided Serratus Anterior Plane Block or Thoracic Paravertebral Block Versus Intravenous Fentanyl for On-pump Coronary Artery Bypass Graft Surgery
Intra and Post Operative Pain Management, Fast Track Program,(Enhanced Recovery After Surgery (ERAS))
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Impact of High Thoracic Paravertebral Block on Diaphragmatic Function: a Prospective Study
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Sensory Anesthesia Achieved Through Different Paravertebral Block Approaches for Post-Op Pain Management After VATS Lung Resection
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Ultrasound-Guided Rhomboid-Intercostal Block Versus Thoracic Paravertebral Block for VATS Analgesia
Postoperative Pain, Thoracic Surgery
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Quality of Recovery After Primary Breast Cancer Surgery Comparing Thoracic Paravertebral Block and Intravenous Lidocaine Infusion.
Pain Management After Major Breast Surgery, Well Being After Major Breast Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaoliang Wang study director
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCTL superficial plane block and SCTL deep plane block group in people with Thoracic Paravertebral Block and Anesthesia Induction, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yajie Xu (86 18651815258, xuyajiechina@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hypotension (time frame: From the beginning of induction to 5 minutes after induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06841822, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.