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

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

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
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.

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 ]

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 ]
  • 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 ]

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

Ages Eligible for Study:   18 Years to 65 Years   (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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00733421

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

Responsible Party: Jan Jakobsson, Foot & Ancle Surgical Center 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

Keywords provided by Karolinska Institutet:
Day surgery
Hallux Valgus

Additional relevant MeSH terms:
Pain, Postoperative
Hallux Valgus
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Foot Deformities
Musculoskeletal Diseases
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Analgesics, Opioid
Central Nervous System Depressants
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Antirheumatic Agents processed this record on September 21, 2017