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

NCT ID: NCT00733421

Last Updated: 2010-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2009-08-31

Brief 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

Detailed Description

See brief summary

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Active study drug:

Etoricoxib 90 mg once daily

Group Type: EXPERIMENTAL

etoricoxib

Intervention Type: DRUG

90 mg once daily

2

Tramadol 100 mg slow release twice daily

Group Type: ACTIVE_COMPARATOR

tramadol

Intervention Type: DRUG

100 mg twice daily

Interventions

etoricoxib

90 mg once daily

Intervention Type: DRUG

tramadol

100 mg twice daily

Intervention Type: DRUG

Other Intervention Names

Arcoxia; Tiparol

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Foot & Ancle Surgical Center

Principal Investigators

Jan Jakobsson, MD, PhD,

Role: PRINCIPAL_INVESTIGATOR

Foot & Ancle Surgical Center

Locations

Foot & Ancle Surgical Center

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

EudraCT number 2008-000791-24

Identifier Type: -

Identifier Source: secondary_id

2008HV001

Identifier Type: -

Identifier Source: org_study_id