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Erector Spinae Plane Block for acute low back pain: a prospective double-blind randomized multicenter study. ESP-BACK

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511595-32-00
Acronym
RECHMPL23_0409
Enrollment
300
Registered
2025-11-26
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-26

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

Conditions

Acute low back pain

Brief summary

Reduction of pain on mobilization (50 % decrease in pain intensity) 30 minutes after the procedure, Validation of the "Get Up and Go" test (completed in less than 20 seconds) 30 minutes after the procedure

Detailed description

Patient-reported VAS pain score from day 0 to month 6, Score of the Brief Pain Inventory (BPI) questionnaire on day 14, month 3, and month 6, Consumption of rescue analgesic (tramadol) from day 0 to month 6 (total number of tablets), Steps count from day 0 to day 3, Quality of sleep (sleep duration, sleep onset and awakeness numbers in hours) from day 0 to day 3, Score of EIFEL questionnaire on day 3, Score of WOMAC questionnaire on day 14, month 3, and month 6, Number of medical consultations for low back pain up to month 6, Number of physiotherapy sessions for low back pain up to month 6, Number of recurrences of low back pain up to month 6, Score of SF-12 questionnaire, at month 3 and month 6, Side effects related to rescue analgesics (such as nausea, vomiting…) up to month 6, Opioid misuse will be assessed with the score of POMI questionnaire on day 14, month 3, and month 6, Number of days from the procedure to the time returning to work up to month 6, The incremental cost-utility ratio (ICUR) at 6 months, based on costs collected in the study CRF and on utility values derived from the EQ-5D-5L questionnaire

Interventions

DRUGKETOPROFEN
DRUGDEXAMETHASONE PHOSPHATE
DRUGTRAMADOL HYDROCHLORIDE
DRUGPARACETAMOL
DRUGSODIUM CHLORIDE

Sponsors

Centre Hospitalier Universitaire De Montpellier
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Reduction of pain on mobilization (50 % decrease in pain intensity) 30 minutes after the procedure, Validation of the "Get Up and Go" test (completed in less than 20 seconds) 30 minutes after the procedure

Secondary

MeasureTime frame
Patient-reported VAS pain score from day 0 to month 6, Score of the Brief Pain Inventory (BPI) questionnaire on day 14, month 3, and month 6, Consumption of rescue analgesic (tramadol) from day 0 to month 6 (total number of tablets), Steps count from day 0 to day 3, Quality of sleep (sleep duration, sleep onset and awakeness numbers in hours) from day 0 to day 3, Score of EIFEL questionnaire on day 3, Score of WOMAC questionnaire on day 14, month 3, and month 6, Number of medical consultations for low back pain up to month 6, Number of physiotherapy sessions for low back pain up to month 6, Number of recurrences of low back pain up to month 6, Score of SF-12 questionnaire, at month 3 and month 6, Side effects related to rescue analgesics (such as nausea, vomiting…) up to month 6, Opioid misuse will be assessed with the score of POMI questionnaire on day 14, month 3, and month 6, Number of days from the procedure to the time returning to work up to month 6, The incremental cost-utility

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026