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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00733421
Recruitment Status : Completed
First Posted : August 13, 2008
Results First Posted : January 13, 2010
Last Update Posted : January 20, 2010
Information provided by:
Karolinska Institutet

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

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: etoricoxib Drug: tramadol Phase 4

Detailed Description:
See brief summary

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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.
Study Start Date : October 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Bunion
Drug Information available for: Tramadol

Arm Intervention/treatment
Experimental: 1

Active study drug:

Etoricoxib 90 mg once daily

Drug: etoricoxib
90 mg once daily
Other Name: Arcoxia

Active Comparator: 2
Tramadol 100 mg slow release twice daily
Drug: tramadol
100 mg twice daily
Other Name: Tiparol

Primary Outcome Measures :
  1. Number of Patients Requiring Rescue Medication [ Time Frame: 7 day study period ]
    Number of patients requiring any further pain medication

Secondary Outcome Measures :
  1. Summary of Pain Scores, Day 1-7 of Visual Analogue Scale Grading of Pain [ Time Frame: The first 7 days after surgery, during study pain medication ]
    VAS score 1-10 1=no pain 10 = worst possible pain, summary variable day 1-7; 7 - 70

  2. Compliance to Base Medication [ Time Frame: 7-day study period, during study medication ]
    Number of patients that did not discontinue study medication before day 7

  3. Gastro-intestinal Symptoms [ Time Frame: during the 7- day pain medication period ]
    Number of patients reporting any gastro-intestinal side effects; nausea and or vomiting, gastritis etc. assessed by patient and documented in written questionnaire

  4. Dizziness/Sleepiness [ Time Frame: During the 7-day pain medication period ]
    Number of patients that experienced dizziness/sleepiness/fatigue, assessed by patient and documented in written questionnaire

  5. Wound Healing [ Time Frame: 16 week follow-up ]
    healing process assessed by a blinded physician during the final outpatient clinic visit assessment graded; Good/neutral/bad

  6. Satisfaction With Pain Medication [ Time Frame: during the first 20 days after surgery, 1st outpatient clinic visit ]
    satisfied or unsatisfied with study medication, assessed by patient in questionnaire

  7. Patient Assessed Overall Satisfaction With Surgery/Outcome [ Time Frame: 16 weeks ]
    overall satisfaction with outcome, patients assessed satisfaction with the surgical procedure; satisfied, neutral or unsatisfied, written questionnaire.

  8. Patient Assessed Quality of Life [ Time Frame: At 16-week post surgery follow-up ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00733421

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Foot & Ancle Surgical Center
Stockholm, Sweden, 11542
Sponsors and Collaborators
Karolinska Institutet
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Principal Investigator: Jan Jakobsson, MD, PhD, Foot & Ancle Surgical Center
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Responsible Party: Jan Jakobsson, Foot & Ancle Surgical Center Identifier: NCT00733421    
Other Study ID Numbers: 2008HV001
EudraCT number 2008-000791-24
First Posted: August 13, 2008    Key Record Dates
Results First Posted: January 13, 2010
Last Update Posted: January 20, 2010
Last Verified: August 2009
Keywords provided by Karolinska Institutet:
Day surgery
Hallux Valgus
Additional relevant MeSH terms:
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Hallux Valgus
Foot Deformities
Musculoskeletal Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action