NCT06936904

Brief Summary

The aim of this clinical trial is to investigate the effect of different injection speeds on the spread of local anesthetic during ultrasound-guided erector spinae plane block (ESPB) in patients undergoing CT-guided lung nodule localization. The primary question addressed is whether a high injection speed (30 ml delivered within 30 seconds) produces a different local anesthetic distribution compared with a lower injection speed (30 ml delivered within 180 seconds).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress70%
Apr 2025Mar 2027

First Submitted

Initial submission to the registry

April 13, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

April 21, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

May 22, 2025

Status Verified

May 1, 2025

Enrollment Period

1.6 years

First QC Date

April 13, 2025

Last Update Submit

May 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Spread of local anesthetic into the paravertebral space

    Observation of local anesthetic spread into the paravertebral space with CT by a researcher who was blinded to group allocation

    30 minutes after completion of the ESPB block

Secondary Outcomes (8)

  • Diffusion of local anesthetic into intercostal space

    30 minutes after completion of the block

  • Diffusion of local anesthetic into the epidural space

    30 minutes after completion of the block

  • Diffusion of local anesthetic into the neural foramina

    30 minutes after completion of the block

  • Cephalocaudal spread of local anesthetic

    30 minutes after completion of the block

  • Loss to Cold Sensation of Skin

    30 minutes after block

  • +3 more secondary outcomes

Study Arms (2)

Group C

OTHER

A total of 30 ml of the local anesthetic solution (0.375% ropivacaine, comprising 15 ml ropivacaine and 15 ml iodinated contrast) is injected. In the Group C, the injection is administered within 180 seconds.

Procedure: injection speed

Group S

EXPERIMENTAL

A total of 30 ml of the local anesthetic solution (0.375% ropivacaine, comprising 15 ml ropivacaine and 15 ml iodinated contrast) is injected. In the Group S, the injection is administered within 30 seconds.

Procedure: injection speed

Interventions

Patients undergoing CT-guided lung nodule localization were selected for the study, and ultrasound-guided erector spinae plane block was performed before surgery with different injection speed.

Group CGroup S

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for CT-guided lung nodule localization under local anesthesia will be selected
  • aged 18-80 years
  • BMI 18-30 kg/m²
  • ASA classification I-III

You may not qualify if:

  • Allergy to the study drug or to local anesthetics
  • History of opioid abuse
  • Previous infection at the ESPB or PVB puncture site
  • Peripheral neuropathy
  • Dysfunction of blood coagulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, China

RECRUITING

Study Officials

  • Tao Shan

    Nanjing First Hospital, Nanjing Medical University

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

April 13, 2025

First Posted

April 20, 2025

Study Start

April 21, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

May 22, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations