Knee OsteoarthritisNCT01586429
Ultrasound Guided Femoral Nerve Block Catheter Analgesia Compared With Epidural Analgesia for Patients With Knee OA (Osteoarthritis) Who Underwent Unilateral Total Knee Replacement
An observational study of Knee Osteoarthritis, run by King Saud University at 2 sites in Saudi Arabia.
Trial summary
Post-operative pain following total knee replacement can be disabling and sometimes lead to the need for prolonged hospital stay. Therefore development of improved post-operative modalities for total knee replacement surgery pain control is important. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Ultrasound guided femoral nerve block catheter analgesia compared with epidural analgesia for patients with knee OA (osteoarthritis)
- How many people
- Not given
- Where
- 2 sitesSaudi Arabia
- Study dates
- Start not givento not given
- Phase
- Observational
- 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 30 years and older
- All sexes
- Adult, Older adult
Study population: for patients with knee OA (osteoarthritis) who underwent unilateral total knee replacement.
Who may be able to join
- Male / female, Bilateral or unilateral knee OA (Osteoarthritis), and ASA (American Society of Anesthesiologist classification) 1 and 2.
Who cannot join
- Bilateral total knee replacement, Revision total knee replacement, previous knee surgery, Rheumatoid Arthritis, Avascular necrosis (AVN) knee, Post traumatic or post infectious OA, ASA3 and 4.
Trial locations and contacts
2 sites in 1 country.
Saudi Arabia2 sites, 2 recruiting
- Recruiting
King Saud University
Riyadh, Riyadh Region
Tariq A Alzahrani, MD, +966555702334, talzahrani@ksu.edu.sa
Tariq A Alzahrani, MD
- Recruiting
King Saud University
Riyadh Region, Riyadh Region
Tariq A Alzahrani, MD, +966555702334, talzahrani@ksu.edu.sa
Tariq A Alzahrani, MD
About this study
Post-operative pain following total knee replacement can be disabling and sometimes lead to the need for prolonged hospital stay. Therefore development of improved post-operative modalities for total knee replacement surgery pain control is important. High-resolution ultrasound (US) allows accurate visualization of nerves and surrounding structures and can lead to higher success rates of nerve block. The investigators aim at comparing the analgesic efficacy of ultrasound-guided nerve block catheter compared with epidural analgesia for patients with knee OA who underwent unilateral total knee replacement.
- Conditions
- Knee Osteoarthritis
- Being tested
- Ultrasound guided femoral nerve block catheter analgesia compared with epidural analgesia for patients with knee OA (osteoarthritis)
- Keywords
- comparing the analgesic efficacy of ultrasound-guided nerve block catheter compared with epidural analgesia
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided femoral nerve block catheter analgesia compared with epidural analgesia for patients with knee OA (osteoarthritis)Other
| Study group | Role | What they receive |
|---|---|---|
| Epidural | Not described Receives: Other: Ultrasound guided femoral nerve block catheter analgesia compared with epidural analgesia for patients with knee OA (osteoarthritis) | |
| Femoral catheter | Not described Receives: Other: Ultrasound guided femoral nerve block catheter analgesia compared with epidural analgesia for patients with knee OA (osteoarthritis) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Tariq Alzahrani, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01586429
- Sponsor's protocol ID
- E-12-589
- Status last verified
- Feb 2011
- First submitted
- 25 Apr 2012
- Last updated
- 26 Apr 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Femoral Nerve Block Catheter Analgesia Compared With Epidural Analgesia for Patients With Knee OA (Osteoarthritis) Who Underwent Unilateral Total Knee Replacement
- ClinicalTrials.gov ID
- NCT01586429
- Acronym / sponsor ID
- E-12-589
- Conditions
- Knee Osteoarthritis
- Keywords
- comparing the analgesic efficacy of ultrasound-guided nerve block catheter compared with epidural analgesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- First posted
- 26 Apr 2012 (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.
Post-operative pain following total knee replacement can be disabling and sometimes lead to the need for prolonged hospital stay. Therefore development of improved post-operative modalities for total knee replacement surgery pain control is important. High-resolution ultrasound (US) allows accurate visualization of nerves and surrounding structures and can lead to higher success rates of nerve block. The investigators aim at comparing the analgesic efficacy of ultrasound-guided nerve block catheter compared with epidural analgesia for patients with knee OA who underwent unilateral total knee replacement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural | – | Other: Ultrasound guided femoral nerve block catheter analgesia compared with epidural analgesia for patients with knee OA (osteoarthritis) |
| Femoral catheter | – | Other: Ultrasound guided femoral nerve block catheter analgesia compared with epidural analgesia for patients with knee OA (osteoarthritis) |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- for patients with knee OA (osteoarthritis) who underwent unilateral total knee replacement.
Key inclusion criteria (1 listed)
- Male / female, Bilateral or unilateral knee OA (Osteoarthritis), and ASA (American Society of Anesthesiologist classification) 1 and 2.
Key exclusion criteria (1 listed)
- Bilateral total knee replacement, Revision total knee replacement, previous knee surgery, Rheumatoid Arthritis, Avascular necrosis (AVN) knee, Post traumatic or post infectious OA, ASA3 and 4.
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 |
|---|---|---|
| Ultrasound guided femoral nerve block catheter analgesia compared with epidural analgesia for patients with knee OA (osteoarthritis) | Other | Epidural, Femoral catheter |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2012.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by King Saud University at 2 sites in Saudi Arabia.
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 1 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 26 Apr 2012. 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 Saudi Arabia. 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 Tariq A ALzahrani, MD (+966555702334, talzahrani@ksu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 26 Apr 2012.