NCT06963424

Brief Summary

The primary endpoint of this study is to compare the pain relief and peripheral perfusion index when local anesthetics injected in different final target area during lumbar erector spinae block The secondary endpoint of this study is to compare the procedure related pain

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

April 29, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 9, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

May 13, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

January 9, 2026

Status Verified

May 1, 2025

Enrollment Period

8 months

First QC Date

April 29, 2025

Last Update Submit

January 7, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Numerical rating scale changes among 5 times period

    minimum (1) and maximum value (10), lower score means better treatment outcome

    Baseline, 2 weeks, 4 weeks, 8 weeks after the completion of erector spine plane block

Secondary Outcomes (1)

  • back pain functional scale among 3 times period

    Baseline, 4 weeks, 8 weeks after the completion of erector spine plane block

Study Arms (2)

intertransverse ligagment group

EXPERIMENTAL

lumbar ESPB was performed with final target at intertransverse ligament

Procedure: Erector Spinae Plane Block

transverse process group

PLACEBO COMPARATOR

lumbar ESPB was performed with final target at transverse process

Procedure: Erector Spinae Plane Block

Interventions

lumbar erectro spinae block

intertransverse ligagment grouptransverse process group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • lumbar disc herniation
  • lumbar foraminal stenosis
  • lumbar central stenosis
  • lumbar spondylolisthesis
  • numerical rating scale \> 4
  • back pain functional scale \< 45
  • duration of pain \> 1 mon
  • patients who can fully understand all items described in back pain functional scale

You may not qualify if:

  • Allergy to local anesthetics or contrast medium
  • Pregnancy
  • Spine deformity
  • Prior history of lumbar spine surgery
  • No previous lumbar MRI or CT
  • Patients with coagulation abnormality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Ji Hee

Daegu, Daegu, 42178, South Korea

Location

MeSH Terms

Conditions

Bites and StingsBundle-Branch Block

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and InjuriesHeart BlockArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

April 29, 2025

First Posted

May 9, 2025

Study Start

May 13, 2025

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

January 9, 2026

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations