The safety and efficacy of intrathecal injection with a low-dose of bupivacaine for outpatients with chronic low back and lower extremity pain

The safety and efficacy of intrathecal injection with a low-dose of bupivacaine for outpatients with chronic low back and lower extremity pain - Intrathecal injection with a low-dose of bupivacaine for outpatients with chronic low back and lower extremity pain

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008670

Enrollment

100

Registered

2012-08-10

Start date

2010-03-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic low back and lower extremity pain

Interventions

Intrathecal injection of bupivacaine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Outpatients with chronic low back pain with or without lower extremity pain Age: 20 years or older Patients capable of proper assessment Moderately troublesome pain Duration: at least 3 months Specific disorder explaining the pain

Exclusion criteria

Exclusion criteria: Serious cause of pain (ie, infection, fracture, malignancy) Extensive neurological deficit affecting the anesthetic assessments Severe psychological diseases Serious chronic diseases such as cardiac failure, pulmonary emphysema, and interstitial hepatitis Contraindication to intrathecal injection Previous intrathecal injection therapy Other medications initiated within one week before the study

Design outcomes

Primary

Measure	Time frame
Modified Bromage scale Lower Extremity Motor ScoreBlood Upper dermatome of sensory block pressure and pulse rate	—

Secondary

Measure	Time frame
Numerical rating Scale JOA score Roland Morris disability questionnaire	—

Countries

Japan

Contacts

Public ContactAkifumi Kanai

Kitasato University School of Medicine Department of Anesthesiology

kanaiakifumi@aol.com042-778-8606

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026