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

January 22, 2025 updated by: Second Affiliated Hospital of Soochow University

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215004
        • The Second Affiliated Hospital of Soochow University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: supine group
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.
Behavioral: Supine position
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.
Experimental: lateral decubitus group
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.
Behavioral: lateral decubitus position
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Soochow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 18, 2025

Primary Completion (Estimated)

August 7, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

January 10, 2025

First Submitted That Met QC Criteria

January 22, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 22, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • JD-LK2023067-I01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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