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

NCT00733421 | Completed Phase 4 Results

• 2 other identifiers: 2008HV001EudraCT number 2008-000791-24
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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;

• 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

Conditions

Postoperative Pain

Keywords

Day surgery; Hallux Valgus; Pain; Analgesics

Outcome Measures

Primary Outcomes (1)

• Number of Patients Requiring Rescue Medication

  Number of patients requiring any further pain medication

  7 day study period

Secondary Outcomes (8)

• Summary of Pain Scores, Day 1-7 of Visual Analogue Scale Grading of Pain

  The first 7 days after surgery, during study pain medication

• Compliance to Base Medication

  7-day study period, during study medication

• Gastro-intestinal Symptoms

  during the 7- day pain medication period

• Dizziness/Sleepiness

  During the 7-day pain medication period

• Wound Healing

  16 week follow-up

Study Arms (2)

1

EXPERIMENTAL

Active study drug: Etoricoxib 90 mg once daily

Drug: etoricoxib

2

ACTIVE COMPARATOR

Tramadol 100 mg slow release twice daily

Drug: tramadol

Interventions

etoricoxib DRUG

90 mg once daily

Also known as: Arcoxia

1

tramadol DRUG

100 mg twice daily

Also known as: Tiparol

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Foot & Ancle Surgical Center

Stockholm, 11542, Sweden

Location

MeSH Terms

Conditions

Pain, Postoperative; Hallux Valgus; Pain

Interventions

Etoricoxib; Tramadol

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Foot Deformities; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Amines; Lipids

Results Point of Contact

• Title: Jan Jakobsson PI, MD, PhD, Professor
• Organization: Foot & Ankle Surgical Centre

jan.jakobsson@ki.se

46702500960

Study Officials

• Jan Jakobsson, MD, PhD,

  Foot & Ancle Surgical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 12, 2008
• First Posted: August 13, 2008
• Study Start: October 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: August 1, 2009
• Last Updated: January 20, 2010
• Results First Posted: January 13, 2010

Record last verified: 2009-08

Locations

SE (1)