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Clinical Trials in the EU / 2025-523356-31-01
Authorised Phase III

Comparison of low versus intermediate intravenous dexamethasone doses on rebound pain after ambulatory open foot surgery under popliteal sciatic nerve block: a double-blind clinical trial.

2025-523356-31-01 · tracked via the Priya Life Science EU tracker
Sponsor
Hospital Universitario Dr Peset Aleixandre
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Anesthesia and Analgesia
Decision date
10/12/2025
Enrollment target
180
Sites
Spain

Condition studied

Postoperative pain, Rebound pain after regional anaesthesia

Investigational medicinal product(s)

Dexametasona Kern Pharma 4 mg/ml solución inyectable EFG

Eligibility

Age group
65+ years, 18-64 years
Sex
Female, Male

Primary endpoint

Incidence of rebound pain, defined as a score ≥7 on the Numerical Rating Scale (NRS) following recovery of sensory function after the sciatic nerve block. The NRS (0 = no pain; 10 = worst pain imaginable) will be assessed at 24, 48, and 72 hours postoperatively via telephone follow-up. Patients will be previously instructed on how to use the scale.

Endpoint detail

Time to Onset of Postoperative Pain: Defined as the time interval between the confirmed establishment of the sciatic nerve block and the first perception of pain at the surgical site. This outcome will be assessed through telephone follow-up calls at 24 hours, 48 hours, and, if necessary, 72 hours after the block (for outpatient surgery) to record the timing of pain onset and estimate the duration of sensory block., Adverse Events Related to Dexamethasone: Significant hyperglycemia (>180 mg/dl), defined by capillary blood glucose measurement prior to discharge. Surgical site infection or delayed wound healing, monitored during follow-up for up to 1 month postoperatively.

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-523356-31-01 on CTIS ↗ ← All trials in the EU