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Efficacy of perioperative pregabalin in ankle fractures; a prospective randomized controlled trial

Efficacy of perioperative pregabalin in ankle fractures; a prospective randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0007008
Enrollment
60
Registered
2022-02-18
Start date
2019-11-25
Completion date
Unknown
Last updated
2022-03-08

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

Conditions

None listed

Interventions

Drug : Naxen F (naproxen) 500mg BID - A pale yellow elliptical tablet as a NSAIDs family. Pregabalin 75 mg BID – a half of reddish brown and white hard capsule containing white or light yellow powde
60*8=480, 2 days, so about 1000 mcg) and 0.9% 100 ml of normal saline and 0.3 mg (1 A) of ramosetron are mixed. The injection rate is 2ml/hr, 0.5ml is administered at the time of bolus injection, and

Sponsors

Catholic Kwandong University International St.Mary's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age : from 19 years to 65 years old 2. Trauma within 3 weeks

Exclusion criteria

Exclusion criteria: 1. Pilon fracture, open fracture, multiple fractures 2. Charcot's arthropathy 3. Creatinine > 1.2mg/dl, GFR < 60ml/min/1.73m2, chronic renal disease, peptic ulcer, diabetes mellitus over 5 years, coronary heart disease or myocardial infarction within 1 year 4. Spinal anesthesia, patient who declined to receive PCA 5. Patients who are taking NSAIDs, pregabalin already or who have side effects against those 6. Any surgical history on ipsilateral ankle or arthritic history on ipsilateral ankle 7. Systemic arthritis such as rheumatoid arthritis, gout arthritis 8. Any contraindication to the using drugs 9. Pregnant or breast feeding women

Design outcomes

Primary

MeasureTime frame
pain, Functional recovery, and bone union

Secondary

MeasureTime frame
Use, amount, and the time to first use of narcotic pain killers, any side effects of NSAIDs, pregabalin

Countries

Korea, Republic of

Contacts

Public ContactDong Woo Shim

Catholic Kwandong University International St.Mary's Hospital

dcastle@hanmail.net+82-32-290-3931

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026