The Effect of Anti-inflammatory Analgesics on Pain Following Hallux Valgus Surgery

Karolinska Institute

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: tramadol; Drug: etoricoxib

Study type: Interventional

Funder types: Other

Identifiers

NCT00733421

2008HV001

EudraCT number 2008-000791-24

Details and patient eligibility

About

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

Full description

See brief summary

Enrollment: 100 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Health ASA 1-2 patients 18-65 years of age

Exclusion criteria

• ASA/NSAID allergy
• Renal disease
• Lithium therapy
• Complicated cardiovascular disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

1

Experimental group

Description:

Active study drug: Etoricoxib 90 mg once daily

Treatment:

Drug: etoricoxib

2

Active Comparator group

Description:

Tramadol 100 mg slow release twice daily

Treatment:

Drug: tramadol