Hip OsteoarthritisPhase 4NCT03513276
Effect of Local Infiltration Anesthesia in a Hip Arthroplasty Fast Track Program.
A Phase 4 study testing 100cc of 2% ropivacaine, Saline Solution and Adrenaline 10mcg/ml in people with Hip Osteoarthritis, run by Hospital Mutua de Terrassa at 1 site in Spain.
Trial summary
Fast-track programs in Orthopaedic Surgery require early motion that can only be achieved by optimal pain management protocols. Multimodal analgesia protocols including local infiltration anesthesia (LIA) have obtained excellent results in fast-track programs involving Total Knee Arthroplasty but further research and… Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- 100cc of 2% ropivacaine, Saline Solution and Adrenaline 10mcg/ml
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2016to Feb 2018
- 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 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hip osteoarthritis requiring Total Hip Replacement
Who cannot join
- Mental Disorders
- contraindications for epidural anesthesia
- Neurologic disorders that could interfere with pain evaluation
- allergy to drugs in multimodal analgesic protocol
Trial locations and contacts
1 site in 1 country.
About this study
Fast-track programs in Orthopaedic Surgery require early motion that can only be achieved by optimal pain management protocols. Multimodal analgesia protocols including local infiltration anesthesia (LIA) have obtained excellent results in fast-track programs involving Total Knee Arthroplasty but further research and data is needed in Total Hip Arthoplasty programs.
- Conditions
- Hip Osteoarthritis
- Being tested
- 100cc of 2% ropivacaine, Saline Solution, Adrenaline 10mcg/ml
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100cc of 2% ropivacaineDrug
Multimodal analgesia + Local infiltration anesthesia
Saline SolutionDrug
Multimodal analgesia + Saline solution
Adrenaline 10mcg/mlDrug
| Study group | Role | What they receive |
|---|---|---|
| Multimodal analgesia + Local Infiltration Anesthesia | Experimental | 100cc of 2% ropivacaine + Adrenaline 10mcg/ml + 20cc saline solution Receives: Drug: 100cc of 2% ropivacaine; Drug: Adrenaline 10mcg/ml |
| Multimodal analgesia + saline solution | Active comparator | 120cc of saline solution Receives: Drug: Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measured in Visual Analog Scale
Pain assesed using Visual Analog Scale ( Scoring from 0 to 10)
Measured: Up to 48h postoperatively
Secondary outcomes (3)
Length of hospital stay
Length of hospital stay measured in days
Measured: Up to 1 week
Analgesic requirements
Analgesia requirements needed besides protocol medication Measured in miligrams of drug required(Sevredol) Analgesia required by patient
Measured: Up to 1 week
Complications
Wound dehiscence, Infection, reoperation, dislocation.
Measured: Up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study startFeb 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip OsteoarthritisStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Mutua de Terrassa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, fangles, Hospital Mutua de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513276
- Sponsor's protocol ID
- 00002
- Status last verified
- Apr 2018
- First submitted
- 26 Feb 2018
- Last updated
- 1 May 2018
- Results posted
- No
Publications
Bernaus M, Novellas M, Bartra A, Nunez JH, Angles F. Local infiltration analgesia does not have benefits in fast-track hip arthroplasty programmes: a double-blind, randomised, placebo-controlled, clinical trial. Hip Int. 2022 Nov;32(6):711-716. doi: 10.1177/1120700021992684. Epub 2021 Feb 18.
PubMed 33601948
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Local Infiltration Anesthesia in a Hip Arthroplasty Fast Track Program.
- ClinicalTrials.gov ID
- NCT03513276
- Acronym / sponsor ID
- 00002
- Conditions
- Hip Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Hospital Mutua de TerrassaUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 1 May 2018 (actual)
- 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.
Fast-track programs in Orthopaedic Surgery require early motion that can only be achieved by optimal pain management protocols. Multimodal analgesia protocols including local infiltration anesthesia (LIA) have obtained excellent results in fast-track programs involving Total Knee Arthroplasty but further research and data is needed in Total Hip Arthoplasty programs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal analgesia + Local Infiltration Anesthesia | Experimental | Drug: 100cc of 2% ropivacaine, Drug: Adrenaline 10mcg/ml100cc of 2% ropivacaine + Adrenaline 10mcg/ml + 20cc saline solution |
| Multimodal analgesia + saline solution | Active comparator | Drug: Saline Solution120cc of saline solution |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hip osteoarthritis requiring Total Hip Replacement
Key exclusion criteria (4 listed)
- Mental Disorders
- contraindications for epidural anesthesia
- Neurologic disorders that could interfere with pain evaluation
- allergy to drugs in multimodal analgesic protocol
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 |
|---|---|---|
| 100cc of 2% ropivacaineMultimodal analgesia + Local infiltration anesthesia | Drug | Multimodal analgesia + Local Infiltration Anesthesia |
| Saline SolutionMultimodal analgesia + Saline solution | Drug | Multimodal analgesia + saline solution |
| Adrenaline 10mcg/ml | Drug | Multimodal analgesia + Local Infiltration Anesthesia |
Primary outcome
Pain measured in Visual Analog Scale
Time frame: Up to 48h postoperatively
Pain assesed using Visual Analog Scale ( Scoring from 0 to 10)
3 secondary outcomes
Length of hospital stay
Time frame: Up to 1 week
Analgesic requirements
Time frame: Up to 1 week
Complications
Time frame: Up to 1 week
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 1 May 2018.
- Derived from this study: PubMed 33601948Bernaus M, Novellas M, Bartra A, Nunez JH, Angles F. Local infiltration analgesia does not have benefits in fast-track hip arthroplasty programmes: a double-blind, randomised, placebo-controlled, clinical trial. Hip Int. 2022 Nov;32(6):711-716. doi: 10.1177/1120700021992684. Epub 2021 Feb 18.
Related trials for Hip Osteoarthritis
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Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 100cc of 2% ropivacaine, Saline Solution and Adrenaline 10mcg/ml in people with Hip Osteoarthritis, run by Hospital Mutua de Terrassa at 1 site in Spain.
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 1 May 2018. 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 Spain. 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?
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 measured in Visual Analog Scale (time frame: Up to 48h postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03513276, which also lists 1 linked publication.
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 1 May 2018.