Efficacy of preventive pain medication for Foot and Ankle surgery

Efficacy of preventive analgesia in Foot and Ankle surgery

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-7hx3f22

Enrollment

Unknown

Registered

2023-08-22

Start date

2020-10-01

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Postoperative pain

Interventions

After sample calculation, a sample of 60 patients was predicted (30 in each group). Patients who meet the study inclusion criteria will be assigned to 2 groups: 30 patients in the Control Group (will

D02.092.521

D02.886.590.444

Eligibility

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: patients with degenerative hindfoot diseases with indication of hindfoot modeling arthrodesis

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Brazil

Contacts

Public ContactAmanda Cavalcanti

Instituto Nacional de Traumatologia e Ortopedia

acavalcanti@into.saude.gov.br+55 21 21345498

Outcome results

None listed

Source: REBEC (via WHO ICTRP)