Post-operative PainPhase 4NCT00968955
Effect of Local Infiltration Analgesia in Total Hip Arthroplasty
A Phase 4 study testing Ropivacaine in people with Post-operative Pain, run by Hvidovre University Hospital at 2 sites in Denmark.
Trial summary
The purpose of the study is to compare the effects of per-operative local infiltration analgesia with ropivacaine 0,2 % (150 ML) versus placebo on acute postoperative pain intensity after total hip arthroplasty. The hypothesis is that local infiltration analgesia reduces the acute postoperative pain intensity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- Ropivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesDenmark
- Study dates
- Sep 2009to Jun 2010
- 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
- Elective total hip arthroplasty
- Able to speak and understand danish
- Able to give informed consent
Who cannot join
- Alcohol or medical abuse
- Allergies to local anesthetics
- Age < 18 years
- Daily use of opioids or glucocorticoids
- Pregnancy or breastfeeding
- Opioid intolerance
- Obesity defined as BMI>40 kg/m2
- Diabetic neuropathy and rheumatoid arthritis
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Hvidovre University Hospital
Copenhagen, Hvidover, 2650
Hørsholm Hospital
Hørsholm, Hørsholm, 2970
About this study
Official title: Effect of Local Infiltration Analgesia With Ropivacaine in Total Hip Arthroplasty: a Prospective, Randomized, Double-blind, Placebo-controlled Trail
The purpose of the study is to compare the effects of per-operative local infiltration analgesia with ropivacaine 0,2 % (150 ML) versus placebo on acute postoperative pain intensity after total hip arthroplasty.
The hypothesis is that local infiltration analgesia reduces the acute postoperative pain intensity.
Read the detailed description
In spite of being one of the last century's most successful surgical procedures in treatment of advanced osteoarthritis total hip arthroplasty is still associated with postoperative pain and delayed rehabilitation. We therefore decided to evaluate the effects of per-operative local infiltration analgesia with ropivacaine 0,2 % (150 ML) versus placebo on acute postoperative pain intensity in a well defined, multimodal, fast-track setup after hip arthroplasty. The technique is widely used as standard treatment in many European centers despite its limited evidence.
- Conditions
- Post-operative Pain
- Being tested
- Ropivacaine
- Keywords
- Postoperative acute pain, Total hip arthroplasty, Local infiltration analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Local infiltration with ropivacaine 0,2% (150 ML)
| Study group | Role | What they receive |
|---|---|---|
| Local infiltration with ropivacaine | Active comparator | Local infiltration with ropivacaine 0,2% (150 ML) Receives: Drug: Ropivacaine |
| Local infiltration with saline | Placebo comparator | Local infiltration with saline (150 ML) (placebo) Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain scores on the Visual Analog Scale (during walking)
Measured: up to 8 hours
Secondary outcomes (4)
Additional analgetics measured as cumulated amount i mg
Measured: up to 8 hours
Time spend in hospital measured as nights after surgery
Measured: At discharge (mean 2-3 nights)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: up to 8 hours
Postoperative pain scores on the Visual Analog Scale (at rest)
Measured: up to 8 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck Foundation
- Responsible party
- Principal investigator, Troels Haxholdt Lunn, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00968955
- Sponsor's protocol ID
- H-2-2009-079
- Other IDs
- 2009-41-3785
- Status last verified
- Sep 2011
- First submitted
- 28 Aug 2009
- Last updated
- 29 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Local Infiltration Analgesia With Ropivacaine in Total Hip Arthroplasty: a Prospective, Randomized, Double-blind, Placebo-controlled Trail
- ClinicalTrials.gov ID
- NCT00968955
- Acronym / sponsor ID
- H-2-2009-079
- Conditions
- Post-operative Pain
- Keywords
- Postoperative acute pain, Total hip arthroplasty, Local infiltration analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Lundbeck Foundation
- Study start
- Sep 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 31 Aug 2009 (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 the study is to compare the effects of per-operative local infiltration analgesia with ropivacaine 0,2 % (150 ML) versus placebo on acute postoperative pain intensity after total hip arthroplasty.
The hypothesis is that local infiltration analgesia reduces the acute postoperative pain intensity.
Detailed description
In spite of being one of the last century's most successful surgical procedures in treatment of advanced osteoarthritis total hip arthroplasty is still associated with postoperative pain and delayed rehabilitation. We therefore decided to evaluate the effects of per-operative local infiltration analgesia with ropivacaine 0,2 % (150 ML) versus placebo on acute postoperative pain intensity in a well defined, multimodal, fast-track setup after hip arthroplasty. The technique is widely used as standard treatment in many European centers despite its limited evidence.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local infiltration with ropivacaine | Active comparator | Drug: RopivacaineLocal infiltration with ropivacaine 0,2% (150 ML) |
| Local infiltration with saline | Placebo comparator | Drug: RopivacaineLocal infiltration with saline (150 ML) (placebo) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective total hip arthroplasty
- Able to speak and understand danish
- Able to give informed consent
Key exclusion criteria (8 listed)
- Alcohol or medical abuse
- Allergies to local anesthetics
- Age < 18 years
- Daily use of opioids or glucocorticoids
- Pregnancy or breastfeeding
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 |
|---|---|---|
| RopivacaineLocal infiltration with ropivacaine 0,2% (150 ML) | Drug | Local infiltration with ropivacaine, Local infiltration with saline |
Primary outcome
Postoperative pain scores on the Visual Analog Scale (during walking)
Time frame: up to 8 hours
4 secondary outcomes
Additional analgetics measured as cumulated amount i mg
Time frame: up to 8 hours
Time spend in hospital measured as nights after surgery
Time frame: At discharge (mean 2-3 nights)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: up to 8 hours
Postoperative pain scores on the Visual Analog Scale (at rest)
Time frame: up to 8 hour
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 29 Sep 2011.
Related trials for Post-operative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Post-operative Pain, run by Hvidovre University 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 3 inclusion and 8 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 29 Sep 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?
Postoperative pain scores on the Visual Analog Scale (during walking) (time frame: up to 8 hours). 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 29 Sep 2011.