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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.

Status
Not yet recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523356-31-01
Acronym
DexaRP
Enrollment
180
Registered
2025-12-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-10

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

Conditions

Postoperative pain, Rebound pain after regional anaesthesia

Brief summary

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.

Detailed description

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.

Interventions

DRUGDexametasona Kern Pharma 4 mg/ml solución inyectable EFG

Sponsors

Hospital Universitario Dr Peset Aleixandre
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Spain

Outcome results

None listed

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