Phase 4
N=100
The Effect of Anti-inflammatory Analgesics on Pain Following Hallux Valgus Surgery
Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT00733421 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jan 2010
Primary outcome: Primary: Number of Patients Requiring Rescue Medication — 29; 36 patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- etoricoxib (Drug); tramadol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Karolinska Institutet
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Requiring Rescue Medication |
29; 36 | — |
| SECONDARY Summary of Pain Scores, Day 1-7 of Visual Analogue Scale Grading of Pain |
12; 17 | — |
| SECONDARY Compliance to Base Medication |
49; 43 | — |
| SECONDARY Gastro-intestinal Symptoms |
6; 20 | — |
| SECONDARY Dizziness/Sleepiness |
2; 13 | — |
| SECONDARY Wound Healing |
37; 39; 5; 6; 0; 2 | — |
| SECONDARY Satisfaction With Pain Medication |
47; 39; 2; 10 | — |
| SECONDARY Patient Assessed Overall Satisfaction With Surgery/Outcome |
45; 44; 4; 4; 0; 1 | — |
| SECONDARY Patient Assessed Quality of Life |
94.5; 94.7 | — |
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
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
Data sourced from ClinicalTrials.gov (NCT00733421). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.