Pain, PostoperativePhase 4NCT00603083
Postoperative Pain Treatment in Total Hip Arthroplasty: A Study to Assess the Effect of Local Analgesia
A Phase 4 study testing Ropivacaine, Ketorolac and Adrenalin in people with Pain, Postoperative, run by Vejle Hospital at 2 sites in Denmark.
Trial summary
The purpose of this study is to determine whether the investigator standardized pain treatment plus local pain treatment is more effective than the investigator standardized pain treatment plus placebo in total hip arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Ropivacaine, Ketorolac and Adrenalin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesDenmark
- Study dates
- Jan 2008to Oct 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for an uncemented unilateral Total Hip Replacement because of osteoarthritis
- Willingness and possibility to follow the instructions of the study
- 18 years or older
- written informed consent and authority after it has been read and understood.
Who cannot join
- Operation with anterior approach or using navigation
- Do not understand or speech danish
- Can not use the pain-score Numerical Rating Scale (NRS)
- Special indications for Total Hip Replacement
- Anaesthetized in general anaesthesia where a tube is demanded
- Daily use of strong opioids, based on the investigators assessment
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- Fertile women
- ASA-score: 3 and 4
- Known allergy against the standardized pain treatment, the study drugs and placebo, Ropivacaine, Ketorolac, Adrenalin.
- Treatment with Lithium, Dihydroergotamin, full anticoagulant treatment or MAO-inhibitor
- Following illness:
- Active gastric ulcer or earlier gastrointestinal bleeding, ulceration or perforation of any kind.
- Suspicions of manifest gastrointestinal bleeding and/or cerebrovascular bleeding
- Haemorrhagic diathesis
- Coagulation disorder
- Severe thrombocytopenia
- Severe heart insufficiency
- Severe risk of postoperative bleeding or delayed haemostatic
- Myocardium hypertrophy or ischaemic heart disease
- Hypertension
- Hypovolemics
- Anhydration
- angiooedema
- Asthma
- Bronchospasm
- Severe liver insufficiency
- Rhinostenosis because of polyostotic
- Narrow-angled glaucoma
- Phaeochromocytoma
- Low plasm-potassium
- Thyreotoxicosis
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Orthopaedic Department
Vejle, 7100
Ortopaedic Department, Vejle Hospital
Vejle, 7100
About this study
Official title: Postoperative Pain Treatment in Total Hip Arthroplasty A Randomized Double-blinded Placebo-controlled Study to Assess the Effect of Local Analgesia
The purpose of this study is to determine whether the investigator standardized pain treatment plus local pain treatment is more effective than the investigator standardized pain treatment plus placebo in total hip arthroplasty.
- Conditions
- Pain, Postoperative
- Being tested
- Ropivacaine, Ketorolac and Adrenalin, Placebo
- Keywords
- Hip Arthroplasty, Treatment Outcome, Local Anesthesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine, Ketorolac and AdrenalinDrug
Also called Naropin, Toradol
The local analgesic with Ropivacaine 200 mg, Ketorolac 30 mg and Adrenaline 1 mg is given 10 and 22 hours after the operation. The medicine solution is administrated in a catheter, which is placed in the hip at the end of the operation.
PlaceboDrug
Also called Saline
This group receive Placebo 10 and 22 hours after the operation. The Placebo is given in a catheter, which is placed in the hip at the end of the operation.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | This group receive local analgesic with Ropivacaine 200 mg, Ketorolac 30 mg and Adrenaline 1 mg 10 and 22 hours after the operation. The medicine solution is given in a catheter, wich is placed in the hip at the end of the operation. Receives: Drug: Ropivacaine, Ketorolac and Adrenalin |
| B | Placebo comparator | This group receive Placebo 10 and 22 hours after the operation. The Placebo is given in a catheter, wich is placed in the hip at the end of the operation. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Measured: 24 hours
Opioid Consumption
Measured: 24 hours
Secondary outcomes (5)
Pain score
Measured: 7 days
Opioid consumption
Measured: 3 days
Postoperative Nausea and Vomiting (PONV)
Measured: 3 days
Fatigue
Measured: 3 days
Physical function
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Kjaersgaard-Andersen, Vejle Hospital
- Investigators
- Per Kjaersgaard-Andersen, MD, Principal investigator, Ortopaedic Department, Vejle Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00603083
- Sponsor's protocol ID
- EudraCT number 2007-003890-20
- Other IDs
- S-20070066
- Status last verified
- Dec 2011
- First submitted
- 2 Jan 2008
- Last updated
- 9 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain Treatment in Total Hip Arthroplasty A Randomized Double-blinded Placebo-controlled Study to Assess the Effect of Local Analgesia
- ClinicalTrials.gov ID
- NCT00603083
- Acronym / sponsor ID
- EudraCT number 2007-003890-20
- Conditions
- Pain, Postoperative
- Keywords
- Hip Arthroplasty, Treatment Outcome, Local Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 28 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the investigator standardized pain treatment plus local pain treatment is more effective than the investigator standardized pain treatment plus placebo in total hip arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Ropivacaine, Ketorolac and AdrenalinThis group receive local analgesic with Ropivacaine 200 mg, Ketorolac 30 mg and Adrenaline 1 mg 10 and 22 hours after the operation. The medicine solution is given in a catheter, wich is placed in the hip at the end of the operation. |
| B | Placebo comparator | Drug: PlaceboThis group receive Placebo 10 and 22 hours after the operation. The Placebo is given in a catheter, wich is placed in the hip at the end of the operation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled for an uncemented unilateral Total Hip Replacement because of osteoarthritis
- Willingness and possibility to follow the instructions of the study
- 18 years or older
- written informed consent and authority after it has been read and understood.
Key exclusion criteria (31 listed)
- Operation with anterior approach or using navigation
- Do not understand or speech danish
- Can not use the pain-score Numerical Rating Scale (NRS)
- Special indications for Total Hip Replacement
- Anaesthetized in general anaesthesia where a tube is demanded
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 |
|---|---|---|
| Ropivacaine, Ketorolac and AdrenalinAlso: Naropin, ToradolThe local analgesic with Ropivacaine 200 mg, Ketorolac 30 mg and Adrenaline 1 mg is given 10 and 22 hours after the operation. The medicine solution is administrated in a catheter, which is placed in the hip at the end of the operation. | Drug | A |
| PlaceboAlso: SalineThis group receive Placebo 10 and 22 hours after the operation. The Placebo is given in a catheter, which is placed in the hip at the end of the operation. | Drug | B |
Primary outcome
Pain score
Time frame: 24 hours
Opioid Consumption
Time frame: 24 hours
5 secondary outcomes
Pain score
Time frame: 7 days
Opioid consumption
Time frame: 3 days
Postoperative Nausea and Vomiting (PONV)
Time frame: 3 days
Fatigue
Time frame: 3 days
Physical function
Time frame: 2 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2011.
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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.
Per Kjaersgaard-Andersen, MD principal investigator
Ortopaedic Department, Vejle Hospital, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine, Ketorolac and Adrenalin in people with Pain, Postoperative, run by Vejle Hospital at 2 sites in Denmark.
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 4 inclusion and 31 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 9 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain score (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 9 Dec 2011.