Efficacy of preventive pain medication for Foot and Ankle surgery

Phase 4

• Conditions: Postoperative pain; C23.550.767

• Registration Number: RBR-7hx3f22
• Lead Sponsor: Instituto Nacional de Traumatologia e Ortopedia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-03-31
• Study Start: 2023-08-22
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

patients with degenerative hindfoot diseases with indication of hindfoot modeling arthrodesis

Exclusion Criteria

Latex allergy; allergy to etoricoxib; gabapentin allergy; chronic opioid use syndrome; acute hindfoot injury; rheumatic diseases; history of Complex Regional Pain Syndrome; neoplastic disease

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expected outcome 1: It is expected to find that the preceptive use of Gabapentin and Etoricoxib are associated with improvement in postoperative chronic neuropathic pain, assessed by DN-4 questionnaire with a score equal to or greater than 4. Data collected one day before and 90 days after the intervention.;Outcome found 1: A decrease in the number needed to treat neuropathic pain from 14.5 to 2.5 was observed for participants with preemptive use of Gapapentin and Etoricoxib, assessed by DN-4 questionnaire with a score equal to or greater than 4. Data collected one day before and 90 days after the intervention.

Secondary Outcome Measures

Name	Time	Method
Expected outcome 2: it is expected to find that the preemptive use of Gabapentin and Etoricoxib are associated with lower plasma levels of interleukin 10, interleukin 6 and tumor necrosis factor alpha, evaluated by ELISA laboratory method. Data collected one day before and 1 day after the intervention.;Outcome found 2: It was observed that the preemptive use of Gabapentin and Etoricoxib did not present a statistically significant correlation with lower plasma levels of interleukin 10, interleukin 6 and tumor necrosis factor alpha, evaluated by the ELISA laboratory method. Data collected one day before and 1 day after the intervention.