The Effect of Anti-inflammatory Analgesics on Pain Following Hallux Valgus Surgery
Condition: Postoperative Pain
MeSH terms: Hallux Valgus
Intervention: etoricoxib; tramadol
Intervention description: 90 mg once daily; 100 mg twice daily
Intervention MeSH terms: Etoricoxib; Tramadol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 100.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Day surgery; Hallux Valgus; Pain; Analgesics

Summary:

      The effects of none-steroidal anti-inflammatory drugs (NSAIDs) and selective cyclooxygenase
      inhibitors (Coxibs) on the formation of bone and fracture healing have been a matter of
      debate since long.

      There is, however, limited data in humans and further prospective randomised studies are
      warranted. Ekman et al studied in a prospective randomised double blind study the effects of
      celecoxib, a selective cox-II-inhibitor, on pain and bone healing following spine surgery.
      They found significant effects on reduction of pain and need for opioid analgesics
      postoperatively but could see no negative effects the numbers of "none-unions" at a 1-year
      follow up 3.

      In a similar prospective randomised double-blind study design significant effects in
      reduction of pain and need for rescue analgesia was seen from the use of celecoxib in the
      perioperative multi-modal pain strategy for cruciate-ligament reconstruction and no negative
      effects could bee seen on six month follow-up of the strength of the reconstructed ligament.

      The aim of the present study is to further study the effects of the perioperative use of
      etoricoxib, a selective cox-II-inhibitor (Coxibs), in a prospective randomised double-blind
      study on bone healing, pain and need for rescue analgesia in patients undergoing elective
      Hallux Valgus surgery with a standardised surgical technique including an osteotomy of
      metatarsale I and excision of exostosis.

      Study population 100 American Society of Anesthesiology (ASA) physiological status1-2
      patients scheduled for elective hallux valgus (HV) surgery

      The patients are going to be randomised into 2 groups, 50 patients in each;

        1. etoricoxib 90 mg once daily x 5

        2. tramadol 100 mg twice daily x 5

      First line rescue medication t. paracetamol 1 gr up to 4 gram daily Second line rescue t.
      oxycodone 10 mg

      Primary study variables:

        -  X-ray evaluation (computer tomography (CT)-investigation) of bone healing assessed a
           CT-scan modelling of the osteotomy at twelve weeks after surgery

        -  Number of patients requiring rescue medication

        -  Patient assessment using "brief pain inventory" 24 hours and 2 weeks after surgery

      Secondary study variables are;

        -  Visual Analogue Scale (VAS) grading Day 1-7

        -  Compliance to base medication

        -  Need for rescue analgesia Day 1-7

        -  Adverse Effects

             -  Experience of any emetic symptoms

             -  Experience of any gastrointestinal symptoms

        -  Satisfaction with pain medication Day 20

        -  Wound dressing Day 20

        -  Clinical evaluation 17 weeks, final assessment
    

Eligibility criteria:

        Inclusion Criteria:

          -  Health ASA 1-2 patients 18-65 years of age

        Exclusion Criteria:

          -  ASA/NSAID allergy

          -  Renal disease

          -  Lithium therapy

          -  Complicated cardiovascular disease