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

Postoperative Pain Clinical Trial

Official title:

The Effect of Anti-inflammatory Analgesics on Bone Repair, Pain and Gastro-intestinal Side Effects After Hallux Valgus Surgery; a Prospective Randomised Double-blind Placebo Controlled Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00733421
• Other study ID #: 2008HV001
• Secondary ID: EudraCT number 2
• Status: Completed
• Phase: Phase 4
• First received: August 12, 2008
• Last updated: January 15, 2010
• Start date: October 2008
• Est. completion date: August 2009

Study information

• Verified date: August 2009
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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

Description:

See brief summary

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• ASA/NSAID allergy

• Renal disease

• Lithium therapy

• Complicated cardiovascular disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hallux Valgus
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• etoricoxib
90 mg once daily
• tramadol
100 mg twice daily

Locations

Country	Name	City	State
Sweden	Foot & Ancle Surgical Center	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients Requiring Rescue Medication		7 day study period	No
Secondary	Summary of Pain Scores, Day 1-7 of Visual Analogue Scale Grading of Pain		The first 7 days after surgery, during study pain medication	No
Secondary	Compliance to Base Medication		7-day study period, during study medication	No
Secondary	Gastro-intestinal Symptoms		during the 7- day pain medication period	No
Secondary	Dizziness/Sleepiness		During the 7-day pain medication period	No
Secondary	Wound Healing		16 week follow-up	No
Secondary	Satisfaction With Pain Medication		during the first 20 days after surgery, 1st outpatient clinic visit	No
Secondary	Patient Assessed Overall Satisfaction With Surgery/Outcome		16 weeks	No
Secondary	Patient Assessed Quality of Life		At 16-week post surgery follow-up	No