ArthroplastyTHANCT02186795
Total Hip Arthroplasty Outcomes With Regional and Multimodal Analgesia
An observational study of Arthroplasty and Replacement, Hip, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The goal of this retrospective chart review is to evaluate if the implementation of lumbar plexus block placement for postoperative pain and administration of multimodal oral analgesia have improved conditions in the postoperative period for patients undergoing total hip arthroplasty when compared to the placement of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Hip, Arthritis
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Mar 2014
- Phase
- Observational
- 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
Study population: Patients undergoing primary total hip arthroplasty
Who may be able to join
- Primary total hip arthroplasty, (identified by current procedural terminology (CPT) code 27130) and
- Either a) Epidural or b) Lumbar plexus peripheral nerve block with the administration of multimodal medication after July 2012.
- -
- Exclusion Criteria:Exclusion criteria include THA Revision, ICU admission postoperatively, and dementia, not allowing pain score communication.
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Improvement in Total Hip Arthroplasty Patient Outcomes With Regional Anesthesia and Multimodal Analgesia: A Retrospective Analysis
The goal of this retrospective chart review is to evaluate if the implementation of lumbar plexus block placement for postoperative pain and administration of multimodal oral analgesia have improved conditions in the postoperative period for patients undergoing total hip arthroplasty when compared to the placement of epidurals for postoperative pain management.
Read the detailed description
Primary outcome: 48 hour opiate consumption in patients following THA. ' Secondary outcome: Time to first ambulation, assitstance needed with ambulation, opiate and regional related side effects, time to discharge orders.
- Conditions
- Arthroplasty, Replacement, Hip, Arthritis
- Keywords
- Arthroplasty, Replacement, Hip
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar plexus | Patients received a preoperative lumbar plexus nerve block (20 ml, ropivacaine 0.5%) for postoperative pain management with one to four multimodal oral pain medications (acetaminophen, celecoxib, oxycodone ER, gabapentin, pregabalin) administered preoperatively or in the first 48 hours postoperatively. | |
| Lumbar Epidural | Patients received a lumbar epidural preoperatively for postoperative pain management. Epidural infusions of ropivacaine 0.2% were initiated intraoperatively, administered until the morning of postoperative day 1, and titrated to patient comfort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opiate Consumption
Cumulative 48 Hours Opiate Consumption in Intravenous (IV) Morphine mg Equivalents (MME)
Measured: 48 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startApr 2013
- Primary completionMar 2014
- Study completionMar 2014
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 ArthroplastyStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sylvia Wilson, Medical University of South Carolina
- Investigators
- Sylvia Wilson, M.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186795
- Sponsor's protocol ID
- THA Retrospective Analysis
- Acronym
- THA
- Status last verified
- Jun 2018
- First submitted
- 3 Jul 2014
- Last updated
- 22 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement in Total Hip Arthroplasty Patient Outcomes With Regional Anesthesia and Multimodal Analgesia: A Retrospective Analysis
- ClinicalTrials.gov ID
- NCT02186795
- Acronym / sponsor ID
- THA / THA Retrospective Analysis
- Conditions
- Arthroplasty, Replacement, Hip, Arthritis
- Keywords
- Arthroplasty, Replacement, Hip
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 10 Jul 2014 (estimated)
- Results
- Posted 22 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this retrospective chart review is to evaluate if the implementation of lumbar plexus block placement for postoperative pain and administration of multimodal oral analgesia have improved conditions in the postoperative period for patients undergoing total hip arthroplasty when compared to the placement of epidurals for postoperative pain management.
Detailed description
Primary outcome: 48 hour opiate consumption in patients following THA. ' Secondary outcome: Time to first ambulation, assitstance needed with ambulation, opiate and regional related side effects, time to discharge orders.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumbar plexus | – | –Patients received a preoperative lumbar plexus nerve block (20 ml, ropivacaine 0.5%) for postoperative pain management with one to four multimodal oral pain medications (acetaminophen, celecoxib, oxycodone ER, gabapentin, pregabalin) administered preoperatively or in the first 48 hours postoperatively. |
| Lumbar Epidural | – | –Patients received a lumbar epidural preoperatively for postoperative pain management. Epidural infusions of ropivacaine 0.2% were initiated intraoperatively, administered until the morning of postoperative day 1, and titrated to patient comfort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing primary total hip arthroplasty
Key inclusion criteria (5 listed)
- Primary total hip arthroplasty, (identified by current procedural terminology (CPT) code 27130) and
- Either a) Epidural or b) Lumbar plexus peripheral nerve block with the administration of multimodal medication after July 2012.
- -
- Exclusion Criteria:Exclusion criteria include THA Revision, ICU admission postoperatively, and dementia, not allowing pain score communication.
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Opiate Consumption
Time frame: 48 hours postoperative
Cumulative 48 Hours Opiate Consumption in Intravenous (IV) Morphine mg Equivalents (MME)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sylvia Wilson, M.D. principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty and Replacement, Hip, run by Medical University of South Carolina 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 5 inclusion and 0 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 22 Mar 2019. 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?
Yes. Results are posted in the registry (first posted 22 Mar 2019). 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?
Opiate Consumption (time frame: 48 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 22 Mar 2019.