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

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.

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

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: etoricoxib; Drug: tramadol

Detailed Description

See brief summary

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 11542
    • Foot & Ancle Surgical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Active study drug: Etoricoxib 90 mg once daily	Drug: etoricoxib; 90 mg once daily; Other Names: Arcoxia
Active Comparator: 2; Tramadol 100 mg slow release twice daily	Drug: tramadol; 100 mg twice daily; Other Names: Tiparol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Requiring Rescue Medication	Number of patients requiring any further pain medication	7 day study period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Summary of Pain Scores, Day 1-7 of Visual Analogue Scale Grading of Pain	VAS score 1-10 1=no pain 10 = worst possible pain, summary variable day 1-7; 7 - 70	The first 7 days after surgery, during study pain medication
Compliance to Base Medication	Number of patients that did not discontinue study medication before day 7	7-day study period, during study medication
Gastro-intestinal Symptoms	Number of patients reporting any gastro-intestinal side effects; nausea and or vomiting, gastritis etc. assessed by patient and documented in written questionnaire	during the 7- day pain medication period
Dizziness/Sleepiness	Number of patients that experienced dizziness/sleepiness/fatigue, assessed by patient and documented in written questionnaire	During the 7-day pain medication period
Wound Healing	healing process assessed by a blinded physician during the final outpatient clinic visit assessment graded; Good/neutral/bad	16 week follow-up
Satisfaction With Pain Medication	satisfied or unsatisfied with study medication, assessed by patient in questionnaire	during the first 20 days after surgery, 1st outpatient clinic visit
Patient Assessed Overall Satisfaction With Surgery/Outcome	overall satisfaction with outcome, patients assessed satisfaction with the surgical procedure; satisfied, neutral or unsatisfied, written questionnaire.	16 weeks
Patient Assessed Quality of Life	Quality of Life evaluated by grading on a Visual Analogue Scale in the written questionnaireisual analogue scale grading 0-100; 0 death and 100 perfect quality of life	At 16-week post surgery follow-up

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Jan Jakobsson, MD, PhD,, Foot & Ancle Surgical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: August 12, 2008
• First Submitted That Met QC Criteria: August 12, 2008
• First Posted (Estimate): August 13, 2008

Study Record Updates

• Last Update Posted (Estimate): January 20, 2010
• Last Update Submitted That Met QC Criteria: January 15, 2010
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Keywords: Pain; Hallux Valgus; Analgesics; Day surgery
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Hallux Valgus; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Cyclooxygenase 2 Inhibitors; Tramadol; Etoricoxib
• Other Study ID Numbers: 2008HV001; EudraCT number 2008-000791-24