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NCT Number: NCT06789276

The Impact of Thoracic Paravertebral Nerve Block At Different Positions on Pain Relief in Patients Undergoing Single-Port Thoracoscopic Partial Lung Resection

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.

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Key information

Conditions

Lung Nodules Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215004, China

Location contact

Yifang Zhu

CONTACT

[email protected]

0086+13913193146

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Supine position

Behavioral

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 position

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xuejiao Zhu

CONTACT

[email protected]

0086+18206136339

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Soochow University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 23, 2025
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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