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.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hospital Universitario Dr Peset Aleixandre

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Decision date (initial)

2025-12-10

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To compare the incidence of rebound pain following outpatient open foot surgery under popliteal sciatic nerve block between patients receiving low versus intermediate prophylactic intravenous doses of dexamethasone.

Secondary objectives 2

1. To determine the overall incidence of rebound pain in this clinical context and to analyze the risk factors associated with its occurrence in outpatient patients.
2. To evaluate and compare the incidence of adverse effects related to intravenous dexamethasone use between the low-dose and intermediate-dose groups.

Conditions and MedDRA coding

Postoperative pain

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Adult patients, ASA physical status I–III, scheduled for elective outpatient open orthopedic foot surgery performed under popliteal sciatic nerve block.

Exclusion criteria 5

1. Patients under 18 years of age.
2. Patients with ASA physical status greater than III.
3. Surgery not performed under regional anesthesia or cases with regional anesthesia failure.
4. Patients with Type 1 diabetes mellitus.
5. Patients undergoing treatment for chronic pain.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 2

1. 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.
2. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hospital Universitario Dr Peset Aleixandre

Sponsor organisation

Hospital Universitario Dr Peset Aleixandre

Address

Avinguda De Gaspar Aguilar 90

City

Valencia

Postcode

46017

Country

Spain

Scientific contact point

Organisation

Hospital Universitario Dr Peset Aleixandre

Contact name

Javier Barrio

Public contact point

Organisation

Hospital Universitario Dr Peset Aleixandre

Contact name

Javier Barrio

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications