Postoperative PainPhase 4NCT00733421
The Effect of Anti-inflammatory Analgesics on Pain Following Hallux Valgus Surgery
A Phase 4 study testing etoricoxib and tramadol in people with Postoperative Pain, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- etoricoxib and tramadol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2008to Aug 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Health ASA 1-2 patients 18-65 years of age
Who cannot join
- ASA/NSAID allergy
- Renal disease
- Lithium therapy
- Complicated cardiovascular disease
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read more
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;
- etoricoxib 90 mg once daily x 5
- 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
Read the detailed description
See brief summary
- Conditions
- Postoperative Pain
- Being tested
- etoricoxib, tramadol
- Keywords
- Day surgery, Hallux Valgus, Pain, Analgesics
- Medical subject headings
- Pain, Postoperative, Hallux Valgus, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etoricoxibDrug
Also called Arcoxia
90 mg once daily
tramadolDrug
Also called Tiparol
100 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Active study drug:
Etoricoxib 90 mg once daily Receives: Drug: etoricoxib |
| 2 | Active comparator | Tramadol 100 mg slow release twice daily Receives: Drug: tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Requiring Rescue Medication
Number of patients requiring any further pain medication
Measured: 7 day study period
Secondary outcomes (8)
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
Measured: The first 7 days after surgery, during study pain medication
Compliance to Base Medication
Number of patients that did not discontinue study medication before day 7
Measured: 7-day study period, during study medication
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
Measured: during the 7- day pain medication period
Dizziness/Sleepiness
Number of patients that experienced dizziness/sleepiness/fatigue, assessed by patient and documented in written questionnaire
Measured: During the 7-day pain medication period
Wound Healing
healing process assessed by a blinded physician during the final outpatient clinic visit assessment graded; Good/neutral/bad
Measured: 16 week follow-up
Satisfaction With Pain Medication
satisfied or unsatisfied with study medication, assessed by patient in questionnaire
Measured: during the first 20 days after surgery, 1st outpatient clinic visit
Patient Assessed Overall Satisfaction With Surgery/Outcome
overall satisfaction with outcome, patients assessed satisfaction with the surgical procedure; satisfied, neutral or unsatisfied, written questionnaire.
Measured: 16 weeks
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
Measured: At 16-week post surgery follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2008 (estimated)
- Study startOct 2008
- Primary completionJun 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Investigators
- Jan Jakobsson, MD, PhD,, Principal investigator, Foot & Ancle Surgical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00733421
- Sponsor's protocol ID
- 2008HV001
- Other IDs
- EudraCT number 2008-000791-24
- Status last verified
- Aug 2009
- First submitted
- 12 Aug 2008
- Last updated
- 20 Jan 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00733421
- Acronym / sponsor ID
- 2008HV001
- Conditions
- Postoperative Pain
- Keywords
- Day surgery, Hallux Valgus, Pain, Analgesics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 13 Aug 2008 (estimated)
- Results
- Posted 13 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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;
- etoricoxib 90 mg once daily x 5
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: etoricoxibActive study drug: Etoricoxib 90 mg once daily |
| 2 | Active comparator | Drug: tramadolTramadol 100 mg slow release twice daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Health ASA 1-2 patients 18-65 years of age
Key exclusion criteria (4 listed)
- ASA/NSAID allergy
- Renal disease
- Lithium therapy
- Complicated cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| etoricoxibAlso: Arcoxia90 mg once daily | Drug | 1 |
| tramadolAlso: Tiparol100 mg twice daily | Drug | 2 |
Primary outcome
Number of Patients Requiring Rescue Medication
Time frame: 7 day study period
Number of patients requiring any further pain medication
8 secondary outcomes
Summary of Pain Scores, Day 1-7 of Visual Analogue Scale Grading of Pain
Time frame: The first 7 days after surgery, during study pain medication
Compliance to Base Medication
Time frame: 7-day study period, during study medication
Gastro-intestinal Symptoms
Time frame: during the 7- day pain medication period
Dizziness/Sleepiness
Time frame: During the 7-day pain medication period
Wound Healing
Time frame: 16 week follow-up
Satisfaction With Pain Medication
Time frame: during the first 20 days after surgery, 1st outpatient clinic visit
Patient Assessed Overall Satisfaction With Surgery/Outcome
Time frame: 16 weeks
Patient Assessed Quality of Life
Time frame: At 16-week post surgery follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Jakobsson, MD, PhD, principal investigator
Foot & Ancle Surgical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing etoricoxib and tramadol in people with Postoperative Pain, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Requiring Rescue Medication (time frame: 7 day study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2010.