Osteo ArthritisACOSMNCT01947660
Continuous Regional Anesthesia for Septic Limb Orthopedic Surgery
A study testing Systemic analgesia + Continuous regional anesthesia and Systemic analgesia in people with Osteo Arthritis and Cellulitis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
This study aims to assess the safety of using continuous regional anesthesia for post-operative analgesia during septic limb orthopedic surgery. The study hypothesis is that continuous regional anesthesia would not induce septic complication in the operated limb and could improve post-operative recovery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteo Arthritis, Cellulitis
- What is being tested?
- Systemic analgesia + Continuous regional anesthesia and Systemic analgesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Nov 2015
- Phase
- Interventional
- 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
- Osteo arthritis or cellulitis requiring surgical intervention
- anatomical possibility of regional anesthesia
- age >18 ans
- written informed consent
Who cannot join
- loco-regional anesthesia impossibility (puncture zone infection, local anesthesics allergie, amiodarone or mexilétine treatment, neurologic deficit for exemple)
- patient under tutelle or curatelle
- pregnant or beast feeding woman
Trial locations and contacts
1 site in 1 country.
France1 site
CCOM
Illkirch-Graffenstaden, Alsace, 67400
Eric NOLL, PH, 03 88 55 23 37
KEMPF, PU PH
About this study
This study aims to assess the safety of using continuous regional anesthesia for post-operative analgesia during septic limb orthopedic surgery.
The study hypothesis is that continuous regional anesthesia would not induce septic complication in the operated limb and could improve post-operative recovery.
- Conditions
- Osteo Arthritis, Cellulitis
- Being tested
- Systemic analgesia + Continuous regional anesthesia, Systemic analgesia
- Medical subject headings
- Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic analgesia + Continuous regional anesthesiaDrug
Systemic analgesia + Continuous regional anesthesia, peri neural for the 2 to 4 first days post-operative
Systemic analgesiaDrug
Systemic analgesia as usual
| Study group | Role | What they receive |
|---|---|---|
| Continuous regional anesthesia | Experimental | Not described Receives: Drug: Systemic analgesia + Continuous regional anesthesia |
| Systemic analgesia | Active comparator | Not described Receives: Drug: Systemic analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Septic complication in the operated limb
Septic complication in the operated limb Pain score Nausea and vomiting
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo ArthritisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947660
- Sponsor's protocol ID
- 5492
- Acronym
- ACOSM
- Status last verified
- Sep 2013
- First submitted
- 17 Sep 2013
- Last updated
- 20 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Regional Anesthesia for Septic Limb Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT01947660
- Acronym / sponsor ID
- ACOSM / 5492
- Conditions
- Osteo Arthritis, Cellulitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 20 Sep 2013 (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.
This study aims to assess the safety of using continuous regional anesthesia for post-operative analgesia during septic limb orthopedic surgery.
The study hypothesis is that continuous regional anesthesia would not induce septic complication in the operated limb and could improve post-operative recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous regional anesthesia | Experimental | Drug: Systemic analgesia + Continuous regional anesthesia |
| Systemic analgesia | Active comparator | Drug: Systemic analgesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Osteo arthritis or cellulitis requiring surgical intervention
- anatomical possibility of regional anesthesia
- age >18 ans
- written informed consent
Key exclusion criteria (3 listed)
- loco-regional anesthesia impossibility (puncture zone infection, local anesthesics allergie, amiodarone or mexilétine treatment, neurologic deficit for exemple)
- patient under tutelle or curatelle
- pregnant or beast feeding woman
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 |
|---|---|---|
| Systemic analgesia + Continuous regional anesthesiaSystemic analgesia + Continuous regional anesthesia, peri neural for the 2 to 4 first days post-operative | Drug | Continuous regional anesthesia |
| Systemic analgesiaSystemic analgesia as usual | Drug | Systemic analgesia |
Primary outcome
Septic complication in the operated limb
Time frame: 28 days
Septic complication in the operated limb Pain score Nausea and vomiting
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systemic analgesia + Continuous regional anesthesia and Systemic analgesia in people with Osteo Arthritis and Cellulitis, run by University Hospital, Strasbourg, France 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Sep 2013. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre DIEMUNSCH, PU PH (03 88 12 70 76, pierre.diemunsch@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Septic complication in the operated limb (time frame: 28 days). 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 Sep 2013.