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

This study has been completed.
Sponsor:
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00733421
First received: August 12, 2008
Last updated: January 15, 2010
Last verified: August 2009
  Purpose

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 Intervention Phase
Postoperative Pain
Drug: etoricoxib
Drug: tramadol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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.

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Number of Patients Requiring Rescue Medication [ Time Frame: 7 day study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Compliance to Base Medication [ Time Frame: 7-day study period, during study medication ] [ Designated as safety issue: No ]
  • Gastro-intestinal Symptoms [ Time Frame: during the 7- day pain medication period ] [ Designated as safety issue: No ]
  • Dizziness/Sleepiness [ Time Frame: During the 7-day pain medication period ] [ Designated as safety issue: No ]
  • Wound Healing [ Time Frame: 16 week follow-up ] [ Designated as safety issue: No ]
  • Satisfaction With Pain Medication [ Time Frame: during the first 20 days after surgery, 1st outpatient clinic visit ] [ Designated as safety issue: No ]
  • Patient Assessed Overall Satisfaction With Surgery/Outcome [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Patient Assessed Quality of Life [ Time Frame: At 16-week post surgery follow-up ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: October 2008
Study Completion Date: August 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

See brief summary

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733421

Locations
Sweden
Foot & Ancle Surgical Center
Stockholm, Sweden, 11542
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Jan Jakobsson, MD, PhD, Foot & Ancle Surgical Center
  More Information

No publications provided

Responsible Party: Jan Jakobsson, Foot & Ancle Surgical Center
ClinicalTrials.gov Identifier: NCT00733421     History of Changes
Other Study ID Numbers: 2008HV001, EudraCT number 2008-000791-24
Study First Received: August 12, 2008
Results First Received: December 7, 2009
Last Updated: January 15, 2010
Health Authority: Sweden: Medical Products Agency

Keywords provided by Karolinska Institutet:
Day surgery
Hallux Valgus
Pain
Analgesics

Additional relevant MeSH terms:
Hallux Valgus
Pain, Postoperative
Foot Deformities
Musculoskeletal Diseases
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Analgesics
Tramadol
Etoricoxib
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Antirheumatic Agents
Narcotics
Central Nervous System Depressants
Analgesics, Opioid
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014