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

Phase 4

Completed

Conditions: Postoperative Pain

Interventions: Drug: etoricoxib
Drug: tramadol

Registration Number: NCT00733421

Lead Sponsor: Karolinska Institutet

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

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

ASA/NSAID allergy
Renal disease
Lithium therapy
Complicated cardiovascular disease

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	etoricoxib	Active study drug: Etoricoxib 90 mg once daily
2	tramadol	Tramadol 100 mg slow release twice daily

Primary Outcome Measures

Name	Time	Method
Number of Patients Requiring Rescue Medication	7 day study period	Number of patients requiring any further pain medication

Secondary Outcome Measures

Name	Time	Method
Summary of Pain Scores, Day 1-7 of Visual Analogue Scale Grading of Pain	The first 7 days after surgery, during study pain medication	VAS score 1-10 1=no pain 10 = worst possible pain, summary variable day 1-7; 7 - 70
Compliance to Base Medication	7-day study period, during study medication	Number of patients that did not discontinue study medication before day 7
Gastro-intestinal Symptoms	during the 7- day pain medication period	Number of patients reporting any gastro-intestinal side effects; nausea and or vomiting, gastritis etc. assessed by patient and documented in written questionnaire
Dizziness/Sleepiness	During the 7-day pain medication period	Number of patients that experienced dizziness/sleepiness/fatigue, assessed by patient and documented in written questionnaire
Wound Healing	16 week follow-up	healing process assessed by a blinded physician during the final outpatient clinic visit assessment graded; Good/neutral/bad
Satisfaction With Pain Medication	during the first 20 days after surgery, 1st outpatient clinic visit	satisfied or unsatisfied with study medication, assessed by patient in questionnaire
Patient Assessed Overall Satisfaction With Surgery/Outcome	16 weeks	overall satisfaction with outcome, patients assessed satisfaction with the surgical procedure; satisfied, neutral or unsatisfied, written questionnaire.
Patient Assessed Quality of Life	At 16-week post surgery follow-up	Quality of Life evaluated by grading on a Visual Analogue Scale in the written questionnaireisual analogue scale grading 0-100; 0 death and 100 perfect quality of life