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

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ClinicalTrials.gov Identifier: NCT00733421
Recruitment Status : Completed
First Posted : August 13, 2008
Results First Posted : January 13, 2010
Last Update Posted : January 20, 2010
Sponsor:
Information provided by:
Karolinska Institutet

Tracking Information
First Submitted Date  ICMJE August 12, 2008
First Posted Date  ICMJE August 13, 2008
Results First Submitted Date  ICMJE December 7, 2009
Results First Posted Date  ICMJE January 13, 2010
Last Update Posted Date January 20, 2010
Study Start Date  ICMJE October 2008
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2009)
Number of Patients Requiring Rescue Medication [ Time Frame: 7 day study period ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 12, 2008)
  • Number of Patients Requiring Rescue Medication [ Time Frame: 8 month ]
  • Patient assessment using "brief pain inventory" 24 hours and 2 weeks after surgery [ Time Frame: 8 month ]
Change History Complete list of historical versions of study NCT00733421 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2010)
  • 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 ]
  • Compliance to Base Medication [ Time Frame: 7-day study period, during study medication ]
  • Gastro-intestinal Symptoms [ Time Frame: during the 7- day pain medication period ]
  • Dizziness/Sleepiness [ Time Frame: During the 7-day pain medication period ]
  • Wound Healing [ Time Frame: 16 week follow-up ]
  • Satisfaction With Pain Medication [ Time Frame: during the first 20 days after surgery, 1st outpatient clinic visit ]
  • Patient Assessed Overall Satisfaction With Surgery/Outcome [ Time Frame: 16 weeks ]
  • Patient Assessed Quality of Life [ Time Frame: At 16-week post surgery follow-up ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2008)
  • VAS grading Day 1-7 [ Time Frame: 8 month ]
  • Compliance to Base Medication [ Time Frame: 8 month ]
  • Experience of any emetic symptoms [ Time Frame: 8 month ]
  • Experience of any gastrointestinal symptoms [ Time Frame: 8 month ]
  • Satisfaction with pain medication Day 20 [ Time Frame: 8 month ]
  • Wound dressing Day 20 [ Time Frame: 8 month ]
  • Clinical evaluation 17 weeks, final assessment [ Time Frame: 8 month ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Anti-inflammatory Analgesics on Pain Following Hallux Valgus Surgery
Official Title  ICMJE 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.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Pain
Intervention  ICMJE
  • Drug: etoricoxib
    90 mg once daily
    Other Name: Arcoxia
  • Drug: tramadol
    100 mg twice daily
    Other Name: Tiparol
Study Arms  ICMJE
  • Experimental: 1

    Active study drug:

    Etoricoxib 90 mg once daily

    Intervention: Drug: etoricoxib
  • Active Comparator: 2
    Tramadol 100 mg slow release twice daily
    Intervention: Drug: tramadol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 9, 2009)
100
Original Estimated Enrollment  ICMJE
 (submitted: August 12, 2008)
90
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • ASA/NSAID allergy
  • Renal disease
  • Lithium therapy
  • Complicated cardiovascular disease
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00733421
Other Study ID Numbers  ICMJE 2008HV001
EudraCT number 2008-000791-24
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jan Jakobsson, Foot & Ancle Surgical Center
Study Sponsor  ICMJE Karolinska Institutet
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jan Jakobsson, MD, PhD, Foot & Ancle Surgical Center
PRS Account Karolinska Institutet
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP