Efficacy of Erector Spinae Plane Block with Ropivacaine Hydrochloride in Acute Renal Colic Pain Management: A Randomized Controlled Trial

The primary objective of this trial is to evaluate the efficacy of an Erector Spinae Plane Block (ESPB) for pain management in patients presenting with acute renal colic. This intervention is being investigated as an adjunct therapy to address urolithiasis-related pain in the emergency department setting. The study aims to determine if the administration of ropivacaine provides effective analgesia, potentially increasing patient satisfaction and reducing healthcare costs by minimizing the need for hospitalizations and further interventions. 3

The sponsor did not provide information regarding the total number of participants. The study population consists of patients of both male and female genders within specific age ranges. Inclusion requires a confirmed diagnosis of urolithiasis via ultrasound or computed tomography during an emergency department visit. Participants must exhibit persistent pain, defined as a numeric rating scale score of 4 or higher, following initial analgesic administration. Eligible individuals must be at least 18 years of age and capable of providing informed consent.

This clinical trial is designed to evaluate the efficacy of an Erector Spinae Plane Block (ESPB) for the management of pain associated with acute renal colic resulting from urolithiasis. The study utilizes a randomized design to compare the administration of ropivacaine hydrochloride against a placebo consisting of sodium chloride. Participants undergo a screening process to confirm eligibility based on age, ultrasound or CT-scan evidence of stones, and persistent pain. Following the intervention, assessments are conducted to monitor pain intensity and interference, the requirement for analgesic rescue medication, and the incidence of adverse events. The protocol includes follow-up evaluations at specific intervals, including 30 minutes, 60 minutes, 6 hours, 12 hours, 24 hours, 7 days, and 1 month to assess quality of life, patient satisfaction, and the incidence of chronic pain. The end-of-study assessment occurs after one month to evaluate safety and cost-effectiveness. The total duration of the study period is estimated to span from March 2026 to September 2028.

The experimental treatment consists of ropivacaine hydrochloride, provided in a PHF00231MIG pharmaceutical form. This substance is administered via injection at a dosage of 3 mg/kg.

The control group receives a placebo composed of potassium chloride, sodium hydrogen carbonate, and sodium chloride. This PHF00169MIG formulation is administered via injection at a volume of 30 ml.

The efficacy of the erector spinae plane block for the management of renal colic is evaluated through several primary endpoints. The first primary endpoint consists of changes in pain intensity and pain interference, assessed using the Brief Pain Inventory Short Form (BPI-SF) at 24 hours post-intervention. The second primary endpoint is the reduction in hospitalizations and urologic interventions, defined by the proportion of patients requiring same-day admission or intervention within seven days.

Secondary efficacy parameters include:

• Changes in pain intensity measured via the Numeric Rating Scale (NRS) at baseline and at intervals of 30 minutes, 60 minutes, six hours, twelve hours, and 24 hours, provided the patient is awake.
• The frequency of emergency department presentations related to renal colic within seven days.
• The incidence of chronic pain, determined by the BPI-SF one month after the intervention.
• Improvements in quality of life as measured by the EQ-5D-5L at seven days and one month compared to baseline.
• Patient satisfaction, assessed through the Patient Global Impression of Change (PGIC) at 24 hours and seven days.
• The frequency of analgesic rescue medication use within the first 24 hours and the time to first analgesic rescue medication, including non-steroidal anti-inflammatory drugs and opioids.
• Reduction in opioid-related adverse events, measured by the Overall Benefit of Analgesia Score at 24 hours.
• Cost-effectiveness, evaluated through healthcare utilization and productivity losses using the iMTA Medical Consumption Questionnaire (iMCQ) and the iMTA Productivity Cost Questionnaire (iPCQ) up to one month post-intervention.