Clinical trial NCT00733421: The Effect of Anti-inflammatory Analgesics on Pain Following Hallux Valgus Surgery
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: Day surgery
Hallux Valgus
Pain
Analgesics
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2008-08-13
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Number of Patients Requiring Rescue Medication
timeFrame: 7 day study period
Secondary outcomes:
measure: Summary of Pain Scores, Day 1-7 of Visual Analogue Scale Grading of Pain
timeFrame: The first 7 days after surgery, during study pain medication
measure: Compliance to Base Medication
timeFrame: 7-day study period, during study medication
measure: Gastro-intestinal Symptoms
timeFrame: during the 7- day pain medication period
measure: Dizziness/Sleepiness
timeFrame: During the 7-day pain medication period
measure: Wound Healing
timeFrame: 16 week follow-up
measure: Satisfaction With Pain Medication
timeFrame: during the first 20 days after surgery, 1st outpatient clinic visit
measure: Patient Assessed Overall Satisfaction With Surgery/Outcome
timeFrame: 16 weeks
measure: Patient Assessed Quality of Life
timeFrame: At 16-week post surgery follow-up
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Foot & Ancle Surgical Center
Study officials:
affiliation: Foot & Ancle Surgical Center
name: Jan Jakobsson, MD, PhD,
role: PRINCIPAL_INVESTIGATOR
References: