Arthroplasty, Replacement, HipPhase 2NCT00980616
Use of Local Analgesia With Epinephrine During Total Hip Arthroplasty (THA)
A Phase 2 study testing ropivacaine, physical serum and adrenalin in people with Arthroplasty, Replacement, Hip, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The aim is to determine if the use of infiltration with an adrenalin solution in the operative field of Total Hip Arthroplasty (THA), allays a significant reduction of the cumulated volume of bleeding (pre and post operative) without increasing the per and post operative risks. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Arthroplasty, Replacement, Hip
- What is being tested?
- ropivacaine, physical serum and adrenalin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2009to Mar 2012
- Phase
- Phase 2
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary total hip arthroplasty
- Age between 50 and 85
Who cannot join
- fracture of the femoral neck
- patients with contraindications for local anaesthesia
Trial locations and contacts
1 site in 1 country.
France1 site
CHU Clermont-Ferrand (orthopaedic surgery)
Clermont-Ferrand, 63003
About this study
Official title: Effect of the Injection of Local Analgesia With Epinephrine During Total Hip Arthroplasty on the Blood Losses Per and Operatively.
The aim is to determine if the use of infiltration with an adrenalin solution in the operative field of Total Hip Arthroplasty (THA), allays a significant reduction of the cumulated volume of bleeding (pre and post operative) without increasing the per and post operative risks. At the same time, the effect on the post operational pains is evaluated.
Read the detailed description
This prospective randomized study compares a population receiving a local anaesthetic (ropivacaine, adrenalin and physiological serum) in the operative field to a population undergoing a standard protocol.
The cumulated volume of bleeding per and post operative are recorded and complete blood count (CBC).
- Conditions
- Arthroplasty, Replacement, Hip
- Being tested
- ropivacaine, physical serum and adrenalin
- Keywords
- Arthroplasty, hip, blood losses, pain, local analgesia, epinephrine, Primary total hip arthroplasty
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaine, physical serum and adrenalinDrug
A: experimental group: 235 mg of ropivacaine, 5 ml physical serum and 0.5 mg of adrenalin
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine, serum, adrenalin | Experimental | 235 mg of ropivacaine, 5 ml physical serum and 0.5 mg of adrenalin. Receives: Drug: ropivacaine, physical serum and adrenalin |
| No infiltration | No intervention | B: no infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
measuring volume of cumulated bleeding per and post operative and analyse of complete blood count (CBC)
Measured: pre and post operative
Secondary outcomes (3)
Womac score pre operative, at 3 months and at 12 months
Measured: at 3 months and 12 months
Visual analogue pain score (VAS) during hospitalisation
Measured: at 3 months and 12 months
Consumption of analgesics
Measured: at 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2010
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, HipStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephane Descamps, MD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00980616
- Sponsor's protocol ID
- CHU-0056
- Status last verified
- Mar 2012
- First submitted
- 18 Sep 2009
- Last updated
- 27 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Injection of Local Analgesia With Epinephrine During Total Hip Arthroplasty on the Blood Losses Per and Operatively.
- ClinicalTrials.gov ID
- NCT00980616
- Acronym / sponsor ID
- CHU-0056
- Conditions
- Arthroplasty, Replacement, Hip
- Keywords
- Arthroplasty, hip, blood losses, pain, local analgesia, epinephrine, Primary total hip arthroplasty
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 21 Sep 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 aim is to determine if the use of infiltration with an adrenalin solution in the operative field of Total Hip Arthroplasty (THA), allays a significant reduction of the cumulated volume of bleeding (pre and post operative) without increasing the per and post operative risks. At the same time, the effect on the post operational pains is evaluated.
Detailed description
This prospective randomized study compares a population receiving a local anaesthetic (ropivacaine, adrenalin and physiological serum) in the operative field to a population undergoing a standard protocol.
The cumulated volume of bleeding per and post operative are recorded and complete blood count (CBC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine, serum, adrenalin | Experimental | Drug: ropivacaine, physical serum and adrenalin235 mg of ropivacaine, 5 ml physical serum and 0.5 mg of adrenalin. |
| No infiltration | No intervention | –B: no infiltration |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary total hip arthroplasty
- Age between 50 and 85
Key exclusion criteria (2 listed)
- fracture of the femoral neck
- patients with contraindications for local anaesthesia
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, physical serum and adrenalinA: experimental group: 235 mg of ropivacaine, 5 ml physical serum and 0.5 mg of adrenalin | Drug | Ropivacaine, serum, adrenalin |
Primary outcome
measuring volume of cumulated bleeding per and post operative and analyse of complete blood count (CBC)
Time frame: pre and post operative
3 secondary outcomes
Womac score pre operative, at 3 months and at 12 months
Time frame: at 3 months and 12 months
Visual analogue pain score (VAS) during hospitalisation
Time frame: at 3 months and 12 months
Consumption of analgesics
Time frame: at 3 months and 12 months
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 27 Mar 2012.
Related trials for Arthroplasty, Replacement, Hip
Enrolling by invitation
Comparison of Functional Results of ADM X3-MoP Cup (Stryker) and a CoC Cup (Zimmer) in Young Patients
Arthroplasties, Hip Replacement
Not yet recruiting
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
RecruitingObservational study
The restor3d Outcomes Registry
Joint Replacement, Arthropathy
Not yet recruitingObservational study
Preoperative Muscle Stiffness, Functional Reserve, and Postoperative Quality of Recovery in Lower Extremity Arthroplasty
Osteoarthritis (Knee / Hip), Sarcopenia
RecruitingPhase 4
Low-Volume Pericapsular Nerve Group (PENG) Block With Dexamethasone vs Standard-Volume PENG Block After Total Hip Arthroplasty
Pain, Postoperative, Muscle Weakness
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.
Stephane Descamps, MD principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ropivacaine, physical serum and adrenalin in people with Arthroplasty, Replacement, Hip, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 2 inclusion and 2 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 27 Mar 2012. 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 France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
measuring volume of cumulated bleeding per and post operative and analyse of complete blood count (CBC) (time frame: pre and post operative). 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 27 Mar 2012.