OsteoarthritisPhase 4NCT02658149
Psoas Compartment Block Versus Periarticular Local Anesthetic for Total Hip Arthroplasty
A Phase 4 study testing Ropivacaine with NaCl, Epinephrine and Morphine in people with Osteoarthritis and Arthroplasty, run by Corewell Health East at 1 site in United States.
Trial summary
The primary objective of this study is to examine whether there is a difference in the level of resting pain following total hip arthroplasty with an anterior approach with use of a psoas compartment block versus a local periarticular anesthetic infiltration Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Arthroplasty
- What is being tested?
- Ropivacaine with NaCl, Epinephrine and Morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 2 Jun 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients undergoing unilateral primary total hip arthroplasty by Dr. James Verner at Beaumont Hospital Royal Oak
- Have a diagnosis of primary osteoarthritis (i.e. degenerative joint disease)
- Surgical approach is anterior
Who cannot join
- Minors (age less than 18 years)
- Pregnant (surgically sterile, post-menopausal, or negative blood test)
- Previous ipsilateral hip surgery
- Lumbar instrumentation
- Acute trauma
- Rheumatoid arthritis
Show all 13Show fewer
- Avascular necrosis
- Hip dysplasia
- Known sensitivity, allergy, or contraindication to anesthetics being used in the study
- Narcotic sensitivity
- History of over 6 months of opioid dependency prior to surgery (excluding tramadol)
- Peripheral neuropathy
- Mental/cognitive impairment that would interfere with the patient's self-assessments of function, pain, or quality of life
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psoas Compartment Block Versus Periarticular Local Anesthetic Infiltration for Pain Management for Total Hip Arthroplasty: A Prospective, Randomized Study
The primary objective of this study is to examine whether there is a difference in the level of resting pain following total hip arthroplasty with an anterior approach with use of a psoas compartment block versus a local periarticular anesthetic infiltration
Read the detailed description
A single-center, prospective, randomized clinical trial with a total of 100 patients. One orthopaedic adult reconstruction surgeon at Beaumont Hospital Royal Oak (JJV) will perform all surgeries. After the patient has consented they will be randomized to one of the following two groups:
- Psoas compartment block (n=50)
- Periarticular local anesthetic infiltration (n=50),
The patient will be blinded to the study group.
- Conditions
- Osteoarthritis, Arthroplasty
- Being tested
- Ropivacaine with NaCl, Epinephrine, Morphine, Ketorolac Tromethamine, Ropivacaine
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine with NaClDrug
Also called Naropin with NaCl
50 mL (40 mL of 0.2% Ropivicaine and 10 mL of 0.9% NaCl) are administered into the psoas compartment
EpinephrineDrug
Also called adrenaline
0.15 mg Epinephrine are injected as part of the drug "cocktail"
MorphineDrug
4 mg Morphine are injected as part of the drug "cocktail"
Ketorolac TromethamineDrug
Also called Toradol
30 mg morphine are injected as part of the drug "cocktail"
RopivacaineDrug
Also called Naropin
30 mL 0.5% Ropivicaine are injected as part of the drug "cocktail"
| Study group | Role | What they receive |
|---|---|---|
| Psoas Compartment Block | Experimental | After exposure anesthetic (Ropivacaine with NaCl) is introduced directly into the iliopsoas muscle, where it then spreads to the lumbar plexus (the nerves responsible for sensation around the surgical site). Receives: Drug: Ropivacaine with NaCl |
| Periarticular Local Anesthetic | Active comparator | An anesthetic "cocktail" of four drugs (ropivacaine, epinephrine, ketorolac tromethamine, morphine) is injected at five locations at the surgical site to the surrounding tissues. Receives: Drug: Epinephrine; Drug: Morphine; Drug: Ketorolac Tromethamine; Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score at 3 Hours
Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain
Measured: 3 hours postoperative
Secondary outcomes (4)
Pain Score at 3-24 Hours
Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain
Measured: measured once during time frame 3 hours-24 hours postoperative
Pain Score at 24-48 Hours
Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain
Measured: measured once during time froma 24-48 hours postoperative
Opioid Usage In-hospital at 24 Hours
Total amount of opioids used per patient (measured with Morphine Equivalent Units)
Measured: 24 hours postoperatively
Opioid Usage In-hospital at 48 Hours
Total amount of opioids used per patient (measured with Morphine Equivalent Units)
Measured: 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2016 (estimated)
- Study startMay 2016
- Primary completion11 May 2017
- Study completion2 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Verner, Corewell Health East
- Investigators
- James Verner, MD, Principal investigator, William Beaumont Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658149
- Sponsor's protocol ID
- 2015-422
- Status last verified
- Apr 2018
- First submitted
- 14 Jan 2016
- Last updated
- 9 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psoas Compartment Block Versus Periarticular Local Anesthetic Infiltration for Pain Management for Total Hip Arthroplasty: A Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT02658149
- Acronym / sponsor ID
- 2015-422
- Conditions
- Osteoarthritis, Arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- 11 May 2017 (actual)
- Study completion
- 2 Jun 2017 (actual)
- First posted
- 18 Jan 2016 (estimated)
- Results
- Posted 9 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to examine whether there is a difference in the level of resting pain following total hip arthroplasty with an anterior approach with use of a psoas compartment block versus a local periarticular anesthetic infiltration
Detailed description
A single-center, prospective, randomized clinical trial with a total of 100 patients. One orthopaedic adult reconstruction surgeon at Beaumont Hospital Royal Oak (JJV) will perform all surgeries. After the patient has consented they will be randomized to one of the following two groups:
- Psoas compartment block (n=50)
- Periarticular local anesthetic infiltration (n=50),
The patient will be blinded to the study group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psoas Compartment Block | Experimental | Drug: Ropivacaine with NaClAfter exposure anesthetic (Ropivacaine with NaCl) is introduced directly into the iliopsoas muscle, where it then spreads to the lumbar plexus (the nerves responsible for sensation around the surgical site). |
| Periarticular Local Anesthetic | Active comparator | Drug: Epinephrine, Drug: Morphine, Drug: Ketorolac Tromethamine, Drug: RopivacaineAn anesthetic "cocktail" of four drugs (ropivacaine, epinephrine, ketorolac tromethamine, morphine) is injected at five locations at the surgical site to the surrounding tissues. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing unilateral primary total hip arthroplasty by Dr. James Verner at Beaumont Hospital Royal Oak
- Have a diagnosis of primary osteoarthritis (i.e. degenerative joint disease)
- Surgical approach is anterior
Key exclusion criteria (13 listed)
- Minors (age less than 18 years)
- Pregnant (surgically sterile, post-menopausal, or negative blood test)
- Previous ipsilateral hip surgery
- Lumbar instrumentation
- Acute trauma
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 with NaClAlso: Naropin with NaCl50 mL (40 mL of 0.2% Ropivicaine and 10 mL of 0.9% NaCl) are administered into the psoas compartment | Drug | Psoas Compartment Block |
| EpinephrineAlso: adrenaline0.15 mg Epinephrine are injected as part of the drug "cocktail" | Drug | Periarticular Local Anesthetic |
| Morphine4 mg Morphine are injected as part of the drug "cocktail" | Drug | Periarticular Local Anesthetic |
| Ketorolac TromethamineAlso: Toradol30 mg morphine are injected as part of the drug "cocktail" | Drug | Periarticular Local Anesthetic |
| RopivacaineAlso: Naropin30 mL 0.5% Ropivicaine are injected as part of the drug "cocktail" | Drug | Periarticular Local Anesthetic |
Primary outcome
Pain Score at 3 Hours
Time frame: 3 hours postoperative
Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain
4 secondary outcomes
Pain Score at 3-24 Hours
Time frame: measured once during time frame 3 hours-24 hours postoperative
Pain Score at 24-48 Hours
Time frame: measured once during time froma 24-48 hours postoperative
Opioid Usage In-hospital at 24 Hours
Time frame: 24 hours postoperatively
Opioid Usage In-hospital at 48 Hours
Time frame: 48 hours postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
James Verner, MD principal investigator
William Beaumont Health
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 Ropivacaine with NaCl, Epinephrine and Morphine in people with Osteoarthritis and Arthroplasty, run by Corewell Health East 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 13 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 9 May 2018. 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?
Yes. Results are posted in the registry (first posted 9 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Score at 3 Hours (time frame: 3 hours postoperative). 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 9 May 2018.