Hip ArthroplastyPhase 4NCT00967980
Femoral Versus Psoas Continuous Peripheral Nerve Blocks Following Hip Arthroplasty
A Phase 4 study testing Femoral Nerve Block vs. Psoas Compartment Nerve Block in people with Hip Arthroplasty and Hip Pain, run by University of California, San Diego at 1 site in United States.
Trial summary
The purpose of this research study is to determine if the insertion site of a perineural catheter, or tiny tube placed next to the nerves that go to the hip which you will have surgery, affects the amount of pain relief that is experienced after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Arthroplasty, Hip Pain
- What is being tested?
- Femoral Nerve Block vs. Psoas Compartment Nerve Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Aug 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary, unilateral hip arthroplasty or hip resurfacing
- age greater than or equal to 18 years
- postoperative analgesic plan includes perineural local anesthetic infusion
Who cannot join
- morbid obesity (BMI greater than 40)
- chronic, high-dose opioid use
- history of opioid abuse
- pregnancy
- incarceration
- amu meirp-muscular deficit of the ipsilateral femoral nerve and/or quadriceps muscle
- inability to communicate with hospital staff
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research study is to determine if the insertion site of a perineural catheter, or tiny tube placed next to the nerves that go to the hip which you will have surgery, affects the amount of pain relief that is experienced after surgery.
Read the detailed description
To determine the association between perineural catheter location and postoperative analgesia, analgesic requirements, ambulatory distance, and flexion following hip arthroplasty.
Primary Hypothesis: Differing the catheter insertion site (femoral vs. psoas compartment) for a perineural local anesthetic infusion is not associated with lower pain scores during the 24-hour period beginning the morning following hip arthroplasty.
- Conditions
- Hip Arthroplasty, Hip Pain
- Being tested
- Femoral Nerve Block vs. Psoas Compartment Nerve Block
- Keywords
- pain, Hip Resurfacing, catheter, nerve block, UCSD, hip surgery, psoas, femoral, ambulation, hip flexion, infusion
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral Nerve Block vs. Psoas Compartment Nerve BlockProcedure or surgery
Patients, undergoing hip arthroplasty or hip resurfacing will be randomized to one of two groups: femoral nerve block or psoas compartment nerve block. Patients randomized to femoral nerve block will receive this block prior to surgery. Patients randomized to psoas compartment nerve block will receive this block prior to surgery. Both patients will receive Mepivicaine via catheter prior to surgery and following surgery, Ropivicaine via pain pump.
| Study group | Role | What they receive |
|---|---|---|
| 1. Femoral Nerve Block | Active comparator | Patients will be randomized with a computer program to receive a femoral catheter. The catheter will be placed using standard technique. The time of catheter placement will be recorded as well as the pain/discomfort of catheter placement as reported by the patient on a 0-10 scale where 0=no pain/discomfort and 10=worst imaginable pain/discomfort. Receives: Procedure: Femoral Nerve Block vs. Psoas Compartment Nerve Block |
| 2. Psoas Compartment Catheter | Active comparator | Patients will be randomized with a computer program to receive a psoas compartment catheter. The catheter will be placed using standard technique. The time of catheter placement will be recorded as well as the pain/discomfort of catheter placement as reported by the patient on a 0-10 scale where 0=no pain/discomfort and 10=worst imaginable pain/discomfort. Receives: Procedure: Femoral Nerve Block vs. Psoas Compartment Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's mean pain score (NRS) during perineural infusion as measured by the nursing staff at UCSD and entered in the computer system.
Measured: 24 hours beginning 7:30am day following surgery
Secondary outcomes (7)
Analgesic used, as reported by nursing staff in the UCSD computer system.
Measured: 3 days following surgery
Patient's ambulation distance as recorded by therapist (occupational or physical) in the UCSD computer system.
Measured: 3 days following surgery
Hip flexion, in degrees measured with a standard goneometer, as recorded by therapist (occupational or physical) in the UCSD computer system.
Measured: 3 days following surgery
Infusion duration of pain pump, measured on the pump itself in hours and minutes.
Measured: 3 days following surgery
Duration of hospital stay, in hours, as reported in the UCSD computer system.
Measured: 3 days following surgery
Surgical/anesthetic adverse events as reported by hospital staff
Measured: day of surgery and 3 days following
Experiences of patient during the infusion and following, as reported to study staff in a phone conversation, one week following surgery.
Measured: 1 week following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionAug 2010
- Study completionAug 2010
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 ArthroplastyStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Investigators
- Brian M Ilfeld, M.D., M.S., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967980
- Sponsor's protocol ID
- Femoral vs. Psoas PNB Cath Hip
- Status last verified
- Sep 2010
- First submitted
- 27 Aug 2009
- Last updated
- 24 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Ilfeld BM, Mariano ER, Madison SJ, Loland VJ, Sandhu NS, Suresh PJ, Bishop ML, Kim TE, Donohue MC, Kulidjian AA, Ball ST. Continuous femoral versus posterior lumbar plexus nerve blocks for analgesia after hip arthroplasty: a randomized, controlled study. Anesth Analg. 2011 Oct;113(4):897-903. doi: 10.1213/ANE.0b013e318212495b. Epub 2011 Apr 5.
PubMed 21467563
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femoral Versus Psoas Continuous Peripheral Nerve Blocks Following Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT00967980
- Acronym / sponsor ID
- Femoral vs. Psoas PNB Cath Hip
- Conditions
- Hip Arthroplasty, Hip Pain
- Keywords
- pain, Hip Resurfacing, catheter, nerve block, UCSD, hip surgery, psoas, femoral
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 28 Aug 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 purpose of this research study is to determine if the insertion site of a perineural catheter, or tiny tube placed next to the nerves that go to the hip which you will have surgery, affects the amount of pain relief that is experienced after surgery.
Detailed description
To determine the association between perineural catheter location and postoperative analgesia, analgesic requirements, ambulatory distance, and flexion following hip arthroplasty.
Primary Hypothesis: Differing the catheter insertion site (femoral vs. psoas compartment) for a perineural local anesthetic infusion is not associated with lower pain scores during the 24-hour period beginning the morning following hip arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Femoral Nerve Block | Active comparator | Procedure: Femoral Nerve Block vs. Psoas Compartment Nerve BlockPatients will be randomized with a computer program to receive a femoral catheter. The catheter will be placed using standard technique. The time of catheter placement will be recorded as well as the pain/discomfort of catheter placement as reported by the patient on a 0-10 scale where 0=no pain/discomfort and 10=worst imaginable pain/discomfort. |
| 2. Psoas Compartment Catheter | Active comparator | Procedure: Femoral Nerve Block vs. Psoas Compartment Nerve BlockPatients will be randomized with a computer program to receive a psoas compartment catheter. The catheter will be placed using standard technique. The time of catheter placement will be recorded as well as the pain/discomfort of catheter placement as reported by the patient on a 0-10 scale where 0=no pain/discomfort and 10=worst imaginable pain/discomfort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- primary, unilateral hip arthroplasty or hip resurfacing
- age greater than or equal to 18 years
- postoperative analgesic plan includes perineural local anesthetic infusion
Key exclusion criteria (7 listed)
- morbid obesity (BMI greater than 40)
- chronic, high-dose opioid use
- history of opioid abuse
- pregnancy
- incarceration
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 |
|---|---|---|
| Femoral Nerve Block vs. Psoas Compartment Nerve BlockPatients, undergoing hip arthroplasty or hip resurfacing will be randomized to one of two groups: femoral nerve block or psoas compartment nerve block. Patients randomized to femoral nerve block will receive this block prior to surgery. Patients randomized to psoas compartment nerve block will receive this block prior to surgery. Both patients will receive Mepivicaine via catheter prior to surgery and following surgery, Ropivicaine via pain pump. | Procedure or surgery | 1. Femoral Nerve Block, 2. Psoas Compartment Catheter |
Primary outcome
Patient's mean pain score (NRS) during perineural infusion as measured by the nursing staff at UCSD and entered in the computer system.
Time frame: 24 hours beginning 7:30am day following surgery
7 secondary outcomes
Analgesic used, as reported by nursing staff in the UCSD computer system.
Time frame: 3 days following surgery
Patient's ambulation distance as recorded by therapist (occupational or physical) in the UCSD computer system.
Time frame: 3 days following surgery
Hip flexion, in degrees measured with a standard goneometer, as recorded by therapist (occupational or physical) in the UCSD computer system.
Time frame: 3 days following surgery
Infusion duration of pain pump, measured on the pump itself in hours and minutes.
Time frame: 3 days following surgery
Duration of hospital stay, in hours, as reported in the UCSD computer system.
Time frame: 3 days following surgery
Surgical/anesthetic adverse events as reported by hospital staff
Time frame: day of surgery and 3 days following
Experiences of patient during the infusion and following, as reported to study staff in a phone conversation, one week following surgery.
Time frame: 1 week following surgery
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 24 Sep 2010.
- Derived from this study: PubMed 21467563Ilfeld BM, Mariano ER, Madison SJ, Loland VJ, Sandhu NS, Suresh PJ, Bishop ML, Kim TE, Donohue MC, Kulidjian AA, Ball ST. Continuous femoral versus posterior lumbar plexus nerve blocks for analgesia after hip arthroplasty: a randomized, controlled study. Anesth Analg. 2011 Oct;113(4):897-903. doi: 10.1213/ANE.0b013e318212495b. Epub 2011 Apr 5.
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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.
Brian M Ilfeld, M.D., M.S. principal investigator
University of California, San Diego
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 Femoral Nerve Block vs. Psoas Compartment Nerve Block in people with Hip Arthroplasty and Hip Pain, run by University of California, San Diego at 1 site in United States.
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 3 inclusion and 7 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 24 Sep 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 United States. 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?
Patient's mean pain score (NRS) during perineural infusion as measured by the nursing staff at UCSD and entered in the computer system. (time frame: 24 hours beginning 7:30am day following surgery). 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 NCT00967980, 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 24 Sep 2010.