Evaluation of Erector Spinae Plane Block with Ropivacaine Hydrochloride, Dexamethasone Phosphate, and Ketoprofen in Acute Low Back Pain Management

The primary objective of this study is to evaluate the efficacy of the erector spinae plane block (ESPB) in managing non-specific low back pain by reducing pain intensity and facilitating immediate mobility. 5

Secondary objectives include:

• Assessment of patient experience through patient-reported experience measures (PREMs), specifically regarding pain reduction and quality of life.
• Evaluation of functional rehabilitation via patient-reported outcome measures (PROMs), focusing on the resumption of physical activity and walking.
• Investigation of the risk of recurrence of pain episodes.
• Reduction of side effects associated with rescue medication, including nausea, vomiting, and opioid consumption.
• Assessment of the timeframe for return to work.
• Analysis of the cost-utility of the ESPB compared to the current standard of care.

The sponsor did not provide information regarding the total number of participants. The study population consists of adult patients, including both males and females, diagnosed with non-specific low back pain. Eligible individuals must present with symptoms for a duration of five days or less and report a visual analog scale score of 5 or greater during mobilization. Furthermore, participants must demonstrate an inability to walk easily, defined as a failure of the Get Up and Go test in less than 20 seconds. The primary objective is to evaluate the effectiveness of the erector spinae plane block in managing pain and facilitating immediate mobility.

This prospective, double-blind, randomized, multicenter study is designed to evaluate the effectiveness of the erector spinae plane block for the management of acute low back pain. The research methodology involves comparing a test intervention consisting of dexamethasone phosphate and ropivacaine hydrochloride against a placebo composed of sodium chloride. Background medications include ketoprofen, paracetamol, and tramadol hydrochloride. The primary objectives focus on the reduction of pain intensity and the validation of the Get Up and Go test 30 minutes following the procedure. Secondary endpoints involve long-term assessments of pain scores, Brief Pain Inventory, sleep quality, and functional outcomes using the WOMAC questionnaire and SF-12 questionnaire. The study period is estimated to span from October 2025 to October 2028. Participant involvement includes an initial screening to confirm non-specific low back pain and specific functional limitations, the intervention, and various follow-up assessments extending up to 6 months to monitor medical consultations, recurrences, and cost-utility ratios.

The experimental treatment consists of ropivacaine hydrochloride administered as a 20 ml solution for injection and dexamethasone phosphate administered as a 2 ml solution for injection.

The placebo group receives 22 ml of sodium chloride as a solution for injection.

Background therapy includes ketoprofen administered as a 200 mg oral dose and a 100 mg solution for infusion. Additional auxiliary medications consist of tramadol hydrochloride at 300 mg via the oral route and paracetamol administered as a 4 g oral dose or a 1000 mg solution for infusion.

The efficacy of the erector spinae plane block in managing acute low back pain is assessed through several primary and secondary endpoints. The primary endpoints include a 50% reduction in pain intensity during mobilization and the validation of the Get Up and Go test, which must be completed in less than 20 seconds, both measured 30 minutes following the procedure.

Secondary efficacy parameters involve the following:

• Patient-reported VAS pain score from day 0 to month 6.
• Brief Pain Inventory questionnaire scores on day 14, month 3, and month 6.
• Total consumption of rescue analgesic, specifically tramadol, from day 0 to month 6.
• Steps count from day 0 to day 3.
• Quality of sleep, including sleep duration, sleep onset, and awakeness, from day 0 to day 3.
• EIFEL questionnaire score on day 3.
• WOMAC questionnaire scores on day 14, month 3, and month 6.
• Number of medical consultations, physiotherapy sessions, and recurrences of low back pain up to month 6.
• SF-12 questionnaire score at month 3 and month 6.
• Side effects related to rescue analgesics up to month 6.
• Opioid misuse assessed via the POMI questionnaire on day 14, month 3, and month 6.
• Number of days from the procedure to returning to work up to month 6.
• The incremental cost-utility ratio at 6 months, determined by costs and utility values from the EQ-5D-5L questionnaire.