NCT06471907

Brief Summary

The primary endpoint of this study is to compare the pain relief and peripheral perfusion index using different volume of local anesthetics in erector spinae plane block.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 13, 2024

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 24, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

July 5, 2024

Status Verified

July 1, 2024

Enrollment Period

11 months

First QC Date

June 18, 2024

Last Update Submit

July 2, 2024

Conditions

Erector Spinea Plane Block

Outcome Measures

Primary Outcomes (1)

  • Numerical rating scale changes among 5 times period

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

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

Secondary Outcomes (2)

  • back pain functional scale among 3 times period

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

  • Perfusion index changes among 4 times period

    baseline, 10minutes after ESPB, 20 minutes after ESPB, 30 minutes after ESPB

Study Arms (2)

10 ml lumbar ESPB group

PLACEBO COMPARATOR

lumbar ESPB was performed with 10 ml of local anesthetics

Procedure: erector spinae plane block

20 ml lumbar ESPB group

EXPERIMENTAL

lumbar ESPB was performed with 20 ml of local anesthetics

Procedure: erector spinae plane block

Interventions

erector spinae plane blockPROCEDURE

fascial plane injection using ultrasound

10 ml lumbar ESPB group20 ml lumbar ESPB 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, 42601, South Korea

RECRUITING

Central Study Contacts

Ji H Hong

CONTACT

01046794343swon13@daum.net

Ji Hoon Park

CONTACT

0532587760cmjihoon@gmail.com

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

June 18, 2024

First Posted

June 24, 2024

Study Start

June 13, 2024

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

July 5, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)