Dexamethasone (dexamethasone sodium phosphate) for Postoperative pain | Rebound pain after regional anaesthesia

Inclusion criteria

• {"criterion_text":"- Adult patients, ASA physical status I–III, scheduled for elective outpatient open orthopedic foot surgery performed under popliteal sciatic nerve block."}

Exclusion criteria

• {"criterion_text":"- Patients under 18 years of age."}
• {"criterion_text":"- Patients with ASA physical status greater than III."}
• {"criterion_text":"- Surgery not performed under regional anesthesia or cases with regional anesthesia failure."}
• {"criterion_text":"- Patients with Type 1 diabetes mellitus."}
• {"criterion_text":"- Patients undergoing treatment for chronic pain."}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Defined as a score ≥7 on the Numerical Rating Scale (NRS; 0-10). Assessed at 24, 48, and 72 hours postoperatively via telephone follow-up; patients are instructed beforehand on use of the scale."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Time interval from confirmed establishment of the sciatic nerve block to first perception of pain; assessed by telephone follow-up at 24, 48 and, if necessary, 72 hours to record timing and estimate duration of sensory block."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Significant hyperglycaemia defined as capillary blood glucose >180 mg/dl measured prior to discharge; surgical site infection or delayed wound healing monitored during follow-up up to 1 month postoperatively."}

Spain

Earliest CTIS Part Ii Submission Date

11-11-2025

Latest Decision Or Authorization Date

10-12-2025

Processing Time Days

29

Number Of Sites

1

Number Of Participants

180

Primary sponsor

Full Name

Hospital Universitario Dr Peset Aleixandre

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain