Arthropathy of HipNCT02493621

Compare Epidural vs. Lumbar Plexus Analgesia After Hip Arthroplasty

An observational study of Arthropathy of Hip, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The goal of this retrospective chart review is to evaluate if the implementation of lumbar plexus block placement for postoperative pain 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 more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Arthropathy of Hip
Type of treatment: Injection or infusion
How many people: 116 participants
Where: 1 siteUnited States
Study dates: Dec 2014to Jul 2015
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
Healthy volunteers accepted
Adult, Older adult

Study population: The study team will identify subject by the Primary Diagnosis of THA, (identified by CPT code 27130) and 2) either a) Epidural (CPT code 62319) or b) Lumbar plexus peripheral nerve block (CPT 62311 or 64449) with the administration of multimodal medication.

Who may be able to join

18 years and older
Diagnosis of:
Primary THA, (identified by CPT code 27130)
Either a) Epidural (CPT code 62319) or b) Lumbar plexus peripheral nerve block (CPT 62311 or 64449)
Perioperative multimodal medication
Hospitalized from July 1, 2012 to December 17, 2014.

Who cannot join

THA Revision
ICU admission postoperatively
History of dementia

Trial locations and contacts

1 site in 1 country.

United States1 site

Medical University of South Carolina
Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: Compare Effectiveness of Epidural vs. Lumbar Plexus Blocks in Total Hip Arthroplasty (THA) Patients Using Multimodal Pain Control

Read the detailed description

Primary outcome: 48 hour opiate consumption in patients following THA. ' Secondary outcome: Time to first ambulation, assistance needed with ambulation, opiate and regional related side effects, time to discharge orders.

Conditions: Arthropathy of Hip
Keywords: Pain, Postoperative, Nerve Block, Anesthesia, Epidural
Medical subject headings: Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02493621
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.
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 opiate consumption in intravenous (IV) morphine mg equivalents (MME)
Measured: 48 hours postoperative

Secondary outcomes (1)

Time of First Ambulation
Time of first ambulation relative to anesthesia end time (hours)
Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2014Jul 2015

First posted9 Jul 2015 (estimated)
Study startDec 2014
Primary completionJun 2015
Study completionJul 2015

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 Arthropathy of HipStudies 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: 116 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02493621
Sponsor's protocol ID: Pro00040998
Status last verified: Jun 2018
First submitted: 2 Jul 2015
Last updated: 22 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
RecruitingPhase 4
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Hip Disease, Hip Dysplasia
Recruiting
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis

All Arthropathy of Hip trials

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: Compare Effectiveness of Epidural vs. Lumbar Plexus Blocks in Total Hip Arthroplasty (THA) Patients Using Multimodal Pain Control
ClinicalTrials.gov ID: NCT02493621
Acronym / sponsor ID: Pro00040998
Conditions: Arthropathy of Hip
Keywords: Pain, Postoperative, Nerve Block, Anesthesia, Epidural
Study type: Observational
Recruitment status: Completed
Enrolment: 116 participants (actual)
Lead sponsor: Medical University of South CarolinaUniversity, hospital or other
Study start: Dec 2014
Primary completion: Jun 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 9 Jul 2015 (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.

Detailed description

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.
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: Accepted
Age groups: Adult, Older adult
Study population: The study team will identify subject by the Primary Diagnosis of THA, (identified by CPT code 27130) and 2) either a) Epidural (CPT code 62319) or b) Lumbar plexus peripheral nerve block (CPT 62311 or 64449) with the administration of multimodal medication.

Key inclusion criteria (6 listed)

18 years and older
Diagnosis of:
Perioperative multimodal medication
Hospitalized from July 1, 2012 to December 17, 2014.

Key exclusion criteria (3 listed)

THA Revision
ICU admission postoperatively
History of dementia

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 opiate consumption in intravenous (IV) morphine mg equivalents (MME)

1 secondary outcome

Time of First Ambulation
Time frame: 48 hours

Results and safety

Results posted to the registry on 22 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lumbar Plexus	58	58
Lumbar Epidural	58	58

Primary outcome: Opiate Consumption

Time frame: 48 hours postoperative. Mean (Standard Error). Unit: Opiate Consumption (IV MME)

Measure	Lumbar Plexus n = 58	Lumbar Epidural n = 58
Value	64.8 (3.32)	81.3 (4.13)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lumbar Plexus	0 of 58 (0%)	0 of 58 (0%)	0 of 58
Lumbar Epidural	0 of 58 (0%)	0 of 58 (0%)	0 of 58

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.

Related trials for Arthropathy of Hip

Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
RecruitingPhase 4
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Hip Disease, Hip Dysplasia
Recruiting
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis

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, MD 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 Arthropathy of 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 6 inclusion and 3 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?

On the ClinicalTrials.gov record for NCT02493621.

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.