Degenerative Joint DiseaseDA THA painNCT02904993
Study Comparing Regional Anesthetic Blocks and Periarticular Infiltration for the Management of Post-operative Pain After Direct Anterior Total Hip Arthroplasty
A study testing L2 paravertebral block and periarticular injection group in people with Degenerative Joint Disease, run by Mayo Clinic at 1 site in United States.
Trial summary
To compare two methods of post-operative pain management in patients undergoing total hip arthroplasty. There is a perception that the periarticular injections may not be as effective in controlling post-operative pain. Both methods are current standard of care. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Degenerative Joint Disease
- What is being tested?
- L2 paravertebral block and periarticular injection group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Oct 2016
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject scheduled for Direct Anterior unilateral total hip replacement
- Weight ≥ 50 and ≤125 kg
- Intact neurological exam
- Cognitively intact with ability to sign consent
Who cannot join
- Renal insufficiency with creatinine > 1.5 mg/dl
- Allergic to any of the following : Ropivacaine, Epinephrine, Ketorolac, Morphine sulfate, NSAIDs, Tylenol, Neurontin, Morphine, Oxycodone or Dilaudid.
- Subject taking regular narcotic medications prior to surgery (20mg/day Morphine equivalents for >7days)
- Subject with prior open hip surgery who received regional anesthesia or periarticular injection for post op pain management.
- Subject with contraindication for spinal anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Study Comparing Regional Anesthetic Blocks and Periarticular Infiltration for the Management of Post-operative Pain After Direct Anterior Total Hip Replacement
To compare two methods of post-operative pain management in patients undergoing total hip arthroplasty. There is a perception that the periarticular injections may not be as effective in controlling post-operative pain.
Both methods are current standard of care. The investigators want to compare the outcomes of each when patients are randomized to one of the methods compared to the other method of post-operative pain control.
- Conditions
- Degenerative Joint Disease
- Being tested
- L2 paravertebral block, periarticular injection group
- Medical subject headings
- Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L2 paravertebral blockOther
nerve block group will receive preoperatively a L2 paravertebral block with indwelling catheter
periarticular injection groupOther
periarticular injection group will receive the injection cocktail towards the end of the total hip replacement prior to skin closure.
| Study group | Role | What they receive |
|---|---|---|
| L2 paravertebral block | Other | regional anesthetic nerve blocks using an L2 paravertebral block with ropivacaine Receives: Other: L2 paravertebral block |
| periarticular injection group | Active comparator | periarticular local injection into the periarticular soft tissues at the time of hip replacement using a combination of ropivacaine, epinephrine, ketorolac and morphine sulphate (periarticular injection group). Receives: Other: periarticular injection group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pain score
Static and dynamic post-operative pain scores, measured on a 1 - 10 visual analogue scale.
Measured: post-operative to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: PI left the institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Joint DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John M. Redmond, M.D., Mayo Clinic
- Investigators
- John M Redmond, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904993
- Sponsor's protocol ID
- 16-001154
- Acronym
- DA THA pain
- Status last verified
- Nov 2016
- First submitted
- 16 May 2016
- Last updated
- 16 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study Comparing Regional Anesthetic Blocks and Periarticular Infiltration for the Management of Post-operative Pain After Direct Anterior Total Hip Replacement
- ClinicalTrials.gov ID
- NCT02904993
- Acronym / sponsor ID
- DA THA pain / 16-001154
- Conditions
- Degenerative Joint Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left the institution.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 19 Sep 2016 (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.
To compare two methods of post-operative pain management in patients undergoing total hip arthroplasty. There is a perception that the periarticular injections may not be as effective in controlling post-operative pain.
Both methods are current standard of care. The investigators want to compare the outcomes of each when patients are randomized to one of the methods compared to the other method of post-operative pain control.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L2 paravertebral block | Other | Other: L2 paravertebral blockregional anesthetic nerve blocks using an L2 paravertebral block with ropivacaine |
| periarticular injection group | Active comparator | Other: periarticular injection groupperiarticular local injection into the periarticular soft tissues at the time of hip replacement using a combination of ropivacaine, epinephrine, ketorolac and morphine sulphate (periarticular injection group). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject scheduled for Direct Anterior unilateral total hip replacement
- Weight ≥ 50 and ≤125 kg
- Intact neurological exam
- Cognitively intact with ability to sign consent
Key exclusion criteria (5 listed)
- Renal insufficiency with creatinine > 1.5 mg/dl
- Allergic to any of the following : Ropivacaine, Epinephrine, Ketorolac, Morphine sulfate, NSAIDs, Tylenol, Neurontin, Morphine, Oxycodone or Dilaudid.
- Subject taking regular narcotic medications prior to surgery (20mg/day Morphine equivalents for >7days)
- Subject with prior open hip surgery who received regional anesthesia or periarticular injection for post op pain management.
- Subject with contraindication for spinal anesthesia
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 |
|---|---|---|
| L2 paravertebral blocknerve block group will receive preoperatively a L2 paravertebral block with indwelling catheter | Other | L2 paravertebral block |
| periarticular injection groupperiarticular injection group will receive the injection cocktail towards the end of the total hip replacement prior to skin closure. | Other | periarticular injection group |
Primary outcome
Changes in pain score
Time frame: post-operative to 7 days
Static and dynamic post-operative pain scores, measured on a 1 - 10 visual analogue scale.
Results and safety
The study was stopped early (reason given: PI left the institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2016.
- 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.
John M Redmond principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L2 paravertebral block and periarticular injection group in people with Degenerative Joint Disease, run by Mayo Clinic 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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 16 Nov 2016. 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.
Are results available for this study?
The study was stopped early (reason given: PI left the institution.). Results are not available in the source record.
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?
Changes in pain score (time frame: post-operative to 7 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 16 Nov 2016.