NCT06789276

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

January 18, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 23, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 23, 2025

Status Verified

January 1, 2025

Enrollment Period

7 months

First QC Date

January 10, 2025

Last Update Submit

January 22, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    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.

Study Arms (2)

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.

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.

Behavioral: lateral decubitus position

Interventions

Supine positionBEHAVIORAL

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.

supine group

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.

lateral decubitus group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215004, China

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Supine Position

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2025

First Posted

January 23, 2025

Study Start

January 18, 2025

Primary Completion

August 7, 2025

Study Completion

December 31, 2025

Last Updated

January 23, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

Locations