The Effect of Anti-inflammatory Analgesics on Pain Following Hallux Valgus Surgery
Status:
Completed
Trial end date:
2009-08-01
Target enrollment:
Participant gender:
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