Rheumatoid ArthritisNCT01050738
Local Analgesia in Knee- and Hipatroplastic Surgery in Patients With Rheumatic Disease: Extra- vs. Intracapsulare Position of Catheter
A study testing Position of catheter in people with Rheumatoid Arthritis and Orthopedic Surgery, run by Spenshult Hospital at 1 site in Sweden.
Trial summary
Postoperative pain is part of surgery trauma. In orthopedic surgery artroplastic replacement of knee- and hipjoints are common. Postoperative pain relieve can be complicated. A new concept for pain relieve postoperative is local infiltration analgesia (LIA). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rheumatoid Arthritis, Orthopedic Surgery, Analgesia
- What is being tested?
- Position of catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2010to Aug 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing arthroplastic surgery of knee or hip
Who cannot join
- Sensitivity to local anesthetics
- Other reason not to use local anesthetics
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Spenshult Hospital
Oskarström, SE-31392
Igor Dobrydnjov, MD, PhD, +46-352635000, igor.dobrydnjov@spenshult.se
About this study
Postoperative pain is part of surgery trauma. In orthopedic surgery artroplastic replacement of knee- and hipjoints are common. Postoperative pain relieve can be complicated. A new concept for pain relieve postoperative is local infiltration analgesia (LIA). This technique implicates that a catheter is left in the surgical area and that local anestesia can be administered post surgery. The goal is no or only little pain with minimal side effects. The catheter could be placed intra- or extracapsulare. The best position is not known. Primary aim is to study if position of the catheter effects the need of other postoperative analgesia. Secondary aim is to study if the position effects patient mobility within the first two days.
- Conditions
- Rheumatoid Arthritis, Orthopedic Surgery, Analgesia
- Being tested
- Position of catheter
- Medical subject headings
- Arthritis, Rheumatoid, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Position of catheterProcedure or surgery
Position of catheter for administration of local anestesia.
| Study group | Role | What they receive |
|---|---|---|
| Intracapsulare position | Active comparator | Not described Receives: Procedure: Position of catheter |
| Extracapsulare position | Active comparator | Not described Receives: Procedure: Position of catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for other postoperative analgesia.
Measured: 48 hours
Secondary outcomes (1)
Patient mobility within the first 48 hours.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionAug 2010 (estimated)
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spenshult Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Stefan Bergman, MD, PhD, Study chair, R&D-center Spenshult
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050738
- Sponsor's protocol ID
- FOUS09002
- Status last verified
- Aug 2010
- First submitted
- 14 Jan 2010
- Last updated
- 18 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Analgesia in Knee- and Hipatroplastic Surgery in Patients With Rheumatic Disease: Extra- vs. Intracapsulare Position of Catheter
- ClinicalTrials.gov ID
- NCT01050738
- Acronym / sponsor ID
- FOUS09002
- Conditions
- Rheumatoid Arthritis, Orthopedic Surgery, Analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Spenshult HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Aug 2010 (estimated)
- First posted
- 15 Jan 2010 (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.
Postoperative pain is part of surgery trauma. In orthopedic surgery artroplastic replacement of knee- and hipjoints are common. Postoperative pain relieve can be complicated. A new concept for pain relieve postoperative is local infiltration analgesia (LIA). This technique implicates that a catheter is left in the surgical area and that local anestesia can be administered post surgery. The goal is no or only little pain with minimal side effects. The catheter could be placed intra- or extracapsulare. The best position is not known. Primary aim is to study if position of the catheter effects the need of other postoperative analgesia. Secondary aim is to study if the position effects patient mobility within the first two days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracapsulare position | Active comparator | Procedure: Position of catheter |
| Extracapsulare position | Active comparator | Procedure: Position of catheter |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing arthroplastic surgery of knee or hip
Key exclusion criteria (2 listed)
- Sensitivity to local anesthetics
- Other reason not to use local anesthetics
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 |
|---|---|---|
| Position of catheterPosition of catheter for administration of local anestesia. | Procedure or surgery | Extracapsulare position, Intracapsulare position |
Primary outcome
Need for other postoperative analgesia.
Time frame: 48 hours
1 secondary outcome
Patient mobility within the first 48 hours.
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2010.
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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.
Stefan Bergman, MD, PhD study chair
R&D-center Spenshult
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Position of catheter in people with Rheumatoid Arthritis and Orthopedic Surgery, run by Spenshult Hospital at 1 site in Sweden.
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 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: status not confirmed, as of the sponsor's last update on 18 Aug 2010. 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 Sweden. 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 Igor Dobrydnjov, MD, PhD (+46-352635000, igor.dobrydnjov@spenshult.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for other postoperative analgesia. (time frame: 48 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 18 Aug 2010.