Lung NodulesNCT06789276
The Impact of Thoracic Paravertebral Nerve Block At Different Positions on Pain Relief in Patients Undergoing Single-Port Thoracoscopic Partial Lung Resection
A study testing Supine position and lateral decubitus position in people with Lung Nodules and Lung Cancer, run by Second Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
Thoracic surgery is widely recognized as one of the most painful surgical procedures. Compared to open thoracotomy, video-assisted thoracoscopic surgery (VATS) offers similar therapeutic outcomes with less invasiveness, significantly reducing postoperative pain and promoting recovery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Nodules, Lung Cancer
- What is being tested?
- Supine position and lateral decubitus position
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2025to 31 Dec 2025
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 70 years old
- BMI ≥ 18 and ≤ 28
- American Society of Anesthesiologists (ASA) physical status classification I-II ⑷ Patients scheduled for elective thoracoscopic lung resection (including lobectomy, segmentectomy, and wedge resection) ⑸ Patients who agree to participate in this study and sign the informed consent form
Who cannot join
- Patients who refuse to undergo nerve block
- Patients with severe cardiac, pulmonary, hepatic, or renal insufficiency requiring postoperative admission to the ICU for continued treatment (EF < 40%, FEV1/FVC < 40%)
- Abnormal coagulation function ⑷ History of allergy to anesthetic drugs
- History of chronic alcohol use, chronic pain, or long-term use of psychotropic medications ⑹ Scars, infections, or tumors at the puncture site ⑺ History or family history of malignant hyperthermia ⑻ Refusal to participate in this study or inability to cooperate with follow-up or poor compliance
- Termination criteria:
- Failure to comply with the predetermined study protocol ⑵ Occurrence of local anesthetic adverse reactions, puncture needle entering the pleural cavity, or other complications during puncture
- Changes in the patient's condition ⑷ The patient's unwillingness to continue participating in the study
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
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004
Yifang Zhu, 0086+13913193146, sdfeyjg@163.com
About this study
Thoracic surgery is widely recognized as one of the most painful surgical procedures. Compared to open thoracotomy, video-assisted thoracoscopic surgery (VATS) offers similar therapeutic outcomes with less invasiveness, significantly reducing postoperative pain and promoting recovery. Despite the use of video-assisted thoracoscopic surgery (VATS), a significant proportion of patients still experience considerable discomfort. Specifically, 78% of patients report moderate to severe pain, with 27% experiencing moderate pain, 34% severe pain, and 17% very severe pain.
Multiple studies have shown that the use of regional anesthesia, such as thoracic paravertebral nerve block (TPVB), in these surgeries can block the transmission of nociceptive signals via the intercostal nerves, producing good analgesic effects. This can reduce the consumption of postoperative opioids, decrease inflammatory responses, and improve patient survival rates after surgery.
By comparing the differences in hemodynamic parameters, inflammatory stress indicators, and intraoperative and postoperative analgesic effects of thoracic paravertebral nerve block in different preoperative positions for patients undergoing thoracoscopic surgery, we aim to identify the optimal nerve block position, thereby promoting patient recovery.
- Conditions
- Lung Nodules, Lung Cancer
- Being tested
- Supine position, lateral decubitus position
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supine positionBehavioural
For patients scheduled for thoracoscopic surgery, thoracic paravertebral nerve block was performed under ultrasound guidance. After the injection of the drug, patients were positioned in either the supine position.
lateral decubitus positionBehavioural
For patients scheduled for thoracoscopic surgery, thoracic paravertebral nerve block was performed under ultrasound guidance. After the injection of the drug, patients were positioned in the lateral decubitus position with the puncture side up.
| Study group | Role | What they receive |
|---|---|---|
| supine group | Experimental | This study selected patients scheduled for thoracoscopic lung resection at the Second Affiliated Hospital of Soochow University. The patients were divided into two groups using a random number table: the supine group and the lateral decubitus group. Patients who are placed in the supine position after the intervention are assigned to the supine group. Receives: Behavioral: Supine position |
| lateral decubitus group | Experimental | This study selected patients scheduled for thoracoscopic lung resection at the Second Affiliated Hospital of Soochow University. The patients were divided into two groups using a random number table: the supine group and the lateral decubitus group. Patients who are placed in the lateral decubitus position on the affected side after the intervention are assigned to the lateral decubitus group. Receives: Behavioral: lateral decubitus position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Using the Numeric Rating Scale (NRS) scores to assess the postoperative analgesic effect in patients
The primary outcome is to assess the patients' pain levels at 1h, 2h, 8h, 12h, 24h, and 48h postoperatively, as well as the analgesic efficacy of the nerve block, using the Numeric Rating Scale (NRS) scores for static (lying or sitting) and dynamic (coughing) conditions.
The Numeric Rating Scale (NRS) is a simple and effective tool for assessing the intensity of pain, widely used in clinical settings and research. The NRS score is determined by asking patients to select a number between 0 and 10 to represent their level of pain, where 0 indicates no pain and 10 indicates the most severe pain. Specifically, 0 represents no pain, 1-3 represents mild pain, 4-6 represents moderate pain, and 7-10 represents severe pain.
Measured: For each patient enrolled in the study, data collection will commence at the time of enrollment and continue through to 48 hours postoperatively. The timeframe for conducting data analysis and reporting will be capped at one year.
Secondary outcomes (1)
Using the postoperative opioid consumption to assess the postoperative analgesic effect in patients.
The secondary outcome is to assess the total amount of opioids (such as sufentanil) used by patients within 24 hours postoperatively.
By comparing the opioid consumption between two groups of patients, it is possible to determine which treatment plan is more effective in controlling postoperative pain. The amount of opioid consumption can indirectly reflect the postoperative recovery status of patients. Lower consumption generally indicates better pain control and better recovery. Reducing the use of opioids can decrease the incidence of adverse reactions such as postoperative nausea, vomiting, and respiratory depression, thereby improving the postoperative quality of life of patients.
Measured: For each enrolled patient,data collection will commence at the time of enrollment and continue through to 24 hours postoperatively. The period for data analysis and reporting will not exceed one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start18 Jan 2025 (estimated)
- Primary completion7 Aug 2025 (estimated)
- Study completion31 Dec 2025 (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 Lung NodulesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789276
- Sponsor's protocol ID
- JD-LK2023067-I01
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Zhu X, Peng P, Guo J, Zhang L, Zhong H, Zhu J, Xie H. The impact of thoracic paravertebral nerve block at different positions on pain relief in patients undergoing single-port thoracoscopic partial lung resection: study protocol for a randomized controlled trial. Trials. 2026 Feb 3;27(1):99. doi: 10.1186/s13063-025-09198-7.
PubMed 41634718
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Thoracic Paravertebral Nerve Block At Different Positions on Pain Relief in Patients Undergoing Single-Port Thoracoscopic Partial Lung Resection
- ClinicalTrials.gov ID
- NCT06789276
- Acronym / sponsor ID
- JD-LK2023067-I01
- Conditions
- Lung Nodules, Lung Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 18 Jan 2025 (estimated)
- Primary completion
- 7 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Jan 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.
Thoracic surgery is widely recognized as one of the most painful surgical procedures. Compared to open thoracotomy, video-assisted thoracoscopic surgery (VATS) offers similar therapeutic outcomes with less invasiveness, significantly reducing postoperative pain and promoting recovery. Despite the use of video-assisted thoracoscopic surgery (VATS), a significant proportion of patients still experience considerable discomfort. Specifically, 78% of patients report moderate to severe pain, with 27% experiencing moderate pain, 34% severe pain, and 17% very severe pain.
Multiple studies have shown that the use of regional anesthesia, such as thoracic paravertebral nerve block (TPVB), in these surgeries can block the transmission of nociceptive signals via the intercostal nerves, producing good analgesic effects. This can reduce the consumption of postoperative opioids, decrease inflammatory responses, and improve patient survival rates after surgery.
By comparing the differences in hemodynamic parameters, inflammatory stress indicators, and intraoperative and postoperative analgesic effects of thoracic paravertebral nerve block in different preoperative positions for patients undergoing thoracoscopic surgery, we aim to identify the optimal nerve block position, thereby promoting patient recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| supine group | Experimental | Behavioral: Supine positionThis study selected patients scheduled for thoracoscopic lung resection at the Second Affiliated Hospital of Soochow University. The patients were divided into two groups using a random number table: the supine group and the lateral decubitus group. Patients who are placed in the supine position after the intervention are assigned to the supine group. |
| lateral decubitus group | Experimental | Behavioral: lateral decubitus positionThis study selected patients scheduled for thoracoscopic lung resection at the Second Affiliated Hospital of Soochow University. The patients were divided into two groups using a random number table: the supine group and the lateral decubitus group. Patients who are placed in the lateral decubitus position on the affected side after the intervention are assigned to the lateral decubitus group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 and ≤ 70 years old
Key exclusion criteria (7 listed)
- Patients who refuse to undergo nerve block
- Failure to comply with the predetermined study protocol ⑵ Occurrence of local anesthetic adverse reactions, puncture needle entering the pleural cavity, or other complications during puncture
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 |
|---|---|---|
| Supine positionFor patients scheduled for thoracoscopic surgery, thoracic paravertebral nerve block was performed under ultrasound guidance. After the injection of the drug, patients were positioned in either the supine position. | Behavioural | supine group |
| lateral decubitus positionFor patients scheduled for thoracoscopic surgery, thoracic paravertebral nerve block was performed under ultrasound guidance. After the injection of the drug, patients were positioned in the lateral decubitus position with the puncture side up. | Behavioural | lateral decubitus group |
Primary outcome
Using the Numeric Rating Scale (NRS) scores to assess the postoperative analgesic effect in patients
Time frame: For each patient enrolled in the study, data collection will commence at the time of enrollment and continue through to 48 hours postoperatively. The timeframe for conducting data analysis and reporting will be capped at one year.
The primary outcome is to assess the patients' pain levels at 1h, 2h, 8h, 12h, 24h, and 48h postoperatively, as well as the analgesic efficacy of the nerve block, using the Numeric Rating Scale (NRS) scores for static (lying or sitting) and dynamic (coughing) conditions. The Numeric Rating Scale (NRS) is a simple and effective tool for assessing the intensity of pain, widely used in clinical settings and research. The NRS score is determined by asking patients to select a number between 0 and 10 to represent their level of pain, where 0 indicates no pain and 10 indicates the most severe pain. Specifically, 0 represents no pain, 1-3 represents mild pain, 4-6 represents moderate pain, and 7-10 represents severe pain.
1 secondary outcome
Using the postoperative opioid consumption to assess the postoperative analgesic effect in patients.
Time frame: For each enrolled patient,data collection will commence at the time of enrollment and continue through to 24 hours postoperatively. The period for data analysis and reporting will not exceed one year.
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 23 Jan 2025.
- Derived from this study: PubMed 41634718Zhu X, Peng P, Guo J, Zhang L, Zhong H, Zhu J, Xie H. The impact of thoracic paravertebral nerve block at different positions on pain relief in patients undergoing single-port thoracoscopic partial lung resection: study protocol for a randomized controlled trial. Trials. 2026 Feb 3;27(1):99. doi: 10.1186/s13063-025-09198-7.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supine position and lateral decubitus position in people with Lung Nodules and Lung Cancer, run by Second Affiliated Hospital of Soochow 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 3 inclusion and 7 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: opening soon, as of the sponsor's last update on 23 Jan 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. 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 Xuejiao Zhu (0086+18206136339, xuejiaozhu_sz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Using the Numeric Rating Scale (NRS) scores to assess the postoperative analgesic effect in patients (time frame: For each patient enrolled in the study, data collection will commence at the time of enrollment and continue through to 48 hours postoperatively. The timeframe for conducting data analysis and reporting will be capped at one year.). 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 NCT06789276, 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 23 Jan 2025.