Postoperative Pain
Conditions
Keywords
Day surgery, Hallux Valgus, Pain, Analgesics
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
Interventions
DRUGetoricoxib
90 mg once daily
DRUGtramadol
100 mg twice daily
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Requiring Rescue Medication | 7 day study period | Number of patients requiring any further pain medication |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Wound Healing | 16 week follow-up | healing process assessed by a blinded physician during the final outpatient clinic visit assessment graded; Good/neutral/bad |
Countries
Sweden
Participant flow
Recruitment details
All patient recruited and analysed between october 2008 and june 2009
Pre-assignment details
Two patients were excluded after randomization forgot study medication and questionnaire leaving the hospital
Participants by arm
| Arm | Count |
|---|---|
| Etoricoxib Active study drug:
Etoricoxib 90 mg once daily | 50 |
| Control Tramadol Tramadol 100 mg slow release twice daily | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Etoricoxib | Control Tramadol | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 50 Participants | 100 Participants |
| Sex: Female, Male Female | 50 Participants | 50 Participants | 100 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 49 | 35 / 49 |
| serious Total, serious adverse events | 0 / 49 | 0 / 49 |
Outcome results
Primary
Number of Patients Requiring Rescue Medication
Number of patients requiring any further pain medication
Time frame: 7 day study period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etoricoxib | Number of Patients Requiring Rescue Medication | 29 patients |
| Control Tramadol | Number of Patients Requiring Rescue Medication | 36 patients |
Secondary
Compliance to Base Medication
Number of patients that did not discontinue study medication before day 7
Time frame: 7-day study period, during study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etoricoxib | Compliance to Base Medication | 49 patients |
| Control Tramadol | Compliance to Base Medication | 43 patients |
Secondary
Dizziness/Sleepiness
Number of patients that experienced dizziness/sleepiness/fatigue, assessed by patient and documented in written questionnaire
Time frame: During the 7-day pain medication period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etoricoxib | Dizziness/Sleepiness | 2 patients |
| Control Tramadol | Dizziness/Sleepiness | 13 patients |
Secondary
Gastro-intestinal Symptoms
Number of patients reporting any gastro-intestinal side effects; nausea and or vomiting, gastritis etc. assessed by patient and documented in written questionnaire
Time frame: during the 7- day pain medication period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etoricoxib | Gastro-intestinal Symptoms | 6 patients |
| Control Tramadol | Gastro-intestinal Symptoms | 20 patients |
Secondary
Patient Assessed Overall Satisfaction With Surgery/Outcome
overall satisfaction with outcome, patients assessed satisfaction with the surgical procedure; satisfied, neutral or unsatisfied, written questionnaire.
Time frame: 16 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etoricoxib | Patient Assessed Overall Satisfaction With Surgery/Outcome | satisfied | 45 Patients. |
| Etoricoxib | Patient Assessed Overall Satisfaction With Surgery/Outcome | neutral | 4 Patients. |
| Etoricoxib | Patient Assessed Overall Satisfaction With Surgery/Outcome | unsatisfied | 0 Patients. |
| Control Tramadol | Patient Assessed Overall Satisfaction With Surgery/Outcome | satisfied | 44 Patients. |
| Control Tramadol | Patient Assessed Overall Satisfaction With Surgery/Outcome | neutral | 4 Patients. |
| Control Tramadol | Patient Assessed Overall Satisfaction With Surgery/Outcome | unsatisfied | 1 Patients. |
Secondary
Patient Assessed Quality of Life
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
Time frame: At 16-week post surgery follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etoricoxib | Patient Assessed Quality of Life | 94.5 score on a scale | Standard Deviation 9.4 |
| Control Tramadol | Patient Assessed Quality of Life | 94.7 score on a scale | Standard Deviation 7.8 |
Secondary
Satisfaction With Pain Medication
satisfied or unsatisfied with study medication, assessed by patient in questionnaire
Time frame: during the first 20 days after surgery, 1st outpatient clinic visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etoricoxib | Satisfaction With Pain Medication | Satisfied | 47 patients |
| Etoricoxib | Satisfaction With Pain Medication | Not satisfied | 2 patients |
| Control Tramadol | Satisfaction With Pain Medication | Satisfied | 39 patients |
| Control Tramadol | Satisfaction With Pain Medication | Not satisfied | 10 patients |
Secondary
Summary of Pain Scores, Day 1-7 of Visual Analogue Scale Grading of Pain
VAS score 1-10 1=no pain 10 = worst possible pain, summary variable day 1-7; 7 - 70
Time frame: The first 7 days after surgery, during study pain medication
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etoricoxib | Summary of Pain Scores, Day 1-7 of Visual Analogue Scale Grading of Pain | 12 scores on a scale | Standard Deviation 8 |
| Control Tramadol | Summary of Pain Scores, Day 1-7 of Visual Analogue Scale Grading of Pain | 17 scores on a scale | Standard Deviation 11 |
Secondary
Wound Healing
healing process assessed by a blinded physician during the final outpatient clinic visit assessment graded; Good/neutral/bad
Time frame: 16 week follow-up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etoricoxib | Wound Healing | Goood | 37 patients |
| Etoricoxib | Wound Healing | Neutral | 5 patients |
| Etoricoxib | Wound Healing | Bad | 0 patients |
| Control Tramadol | Wound Healing | Goood | 39 patients |
| Control Tramadol | Wound Healing | Neutral | 6 patients |
| Control Tramadol | Wound Healing | Bad | 2 patients |