Hip ArthroplastyPhase 4NCT00934661
Low Dose Extended-release Epidural and Lumbar Plexus Block Compared to Lumbar Plexus Block for Total Hip Resurfacing
A Phase 4 study testing Extended Release Epidural Morphine (EREM) in people with Hip Arthroplasty, run by Wake Forest University at 1 site in United States.
Trial summary
At Wake Forest University, the investigators have been using Extended Release Epidural Morphine (EREM), since late 2004, as part of multimodal analgesia in patients having gynecologic surgeries and hip arthroplasties. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hip Arthroplasty
- What is being tested?
- Extended Release Epidural Morphine (EREM)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Mar 2013
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A primary unilateral Birmingham hip arthroplasty
- Men and women 18-65 years
Who cannot join
- Refusal of regional anesthesia
- Laboratory evidence of coagulopathy (platelet count less than 100,000 cells/microliter of blood, prothrombin time greater than 12.1 seconds, partial thromboplastin time greater than 30 seconds, or international normalized ratio of greater than 1.5)
- Allergy to morphine
- Obstructive sleep apnea
- Body mass index (BMI) greater than 40 kg/m2
- Pregnant or lactating
- Severe renal or hepatic disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Low Dose Extended-release Epidural Morphine in Conjunction With Lumbar Plexus Block Versus Lumbar Plexus Block Alone for Total Hip Resurfacing Arthroplasty: A Randomized Controlled Trial.
At Wake Forest University, the investigators have been using Extended Release Epidural Morphine (EREM), since late 2004, as part of multimodal analgesia in patients having gynecologic surgeries and hip arthroplasties.
Hypothesis:
In patients undergoing a Birmingham total hip arthroplasty (BHA), low dose EREM in conjunction with lumbar plexus block (LPB) will be better than lumbar plexus block alone in increasing proportion of patients who meet discharge criteria within 24 hours.
Read the detailed description
Extended release epidural morphine (EREM, DepoDur®: Endo Pharmaceuticals, Chadds Ford PA) has been studied and increasingly utilized as a method to allow for the improved post-operative analgesia of epidural analgesia without infusions.
At Wake Forest University, the investigators have been using EREM, since late 2004, as part of multimodal analgesia in patients having gynecologic surgeries and hip arthroplasties. The investigators initially decreased our dosages from those recommended (15 mg for lower extremity surgery and 10-15 mg for abdominal surgery), because side effects (nausea, vomiting and hypotension) were felt to be limiting to recovery. The investigators now use 4-7.5 mg in most patients, with 7.5 mg being the exception and have achieved better results. For hip arthroplasties, the investigators currently use 4-5 mg and have performed two retrospective chart reviews on this use; both suggesting that this approach is efficacious. However, these doses have not been studied in a prospective, randomized, double blind trial. The investigators would like to evaluate the efficacy of this dose of EREM used as part of a multimodal regimen. The investigators will compare EREM 4 mg with lumbar plexus block versus lumbar plexus block alone, (providing the rest of our multimodal approach for both patients).
- Conditions
- Hip Arthroplasty
- Being tested
- Extended Release Epidural Morphine (EREM), Placebo
- Keywords
- hip resurfacing, hip arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended Release Epidural Morphine (EREM)Drug
Also called Depodur
A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline
PlaceboDrug
Also called preservative free normal saline, sodium chloride
A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush
| Study group | Role | What they receive |
|---|---|---|
| Extended Release Epidural Morphine | Experimental | Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline Receives: Drug: Extended Release Epidural Morphine (EREM) |
| Placebo Group | Placebo comparator | The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Hospital Stay After Surgery
Measured: From surgery day to hospital discharge, up to 4 days
Secondary outcomes (7)
Total Opioid Consumption
Postoperatively, the patients were observed in the post anesthesia care unit (PACU) until regression of sensory levels is demonstrated. They were provided an intravenous (IV) Patient Controlled Analgesia (PCA) and instructions in its use. Morphine 1mg/ml at standard PCA settings (1.5 ml dose, 10 minute lockout interval, 6 ml hourly limit, no basal infusion) were used for postoperative analgesia until discharge plans were made. (Morphine doses were increased in 0.5ml dose increments if the patients were not achieving adequate analgesia.)
Measured: 96 hours
Patient Satisfaction Score
Verbal satisfaction scores (0-10), higher scores represent better outcomes. Scores will be obtained from patients for 96 hours after surgery.
Measured: 96 hours
Distance Walked at Walking Test
Distance walked at walking test. Longer distance walked represent better outcomes
Measured: 96 hours
Verbal Pain Scores Post-gait
Verbal pain scores (0-10), lower scores represent better outcomes. Score will be obtained from patients for 1 day after surgery, post gait active and at rest.
Measured: 1 day post surgery
Verbal Pain Scores Post-gait
Verbal pain scores (0-10), lower scores represent better outcomes. Score will be obtained from patients for 1 day after surgery, post gait active and at rest.
Measured: 2 Days Post Surgery
Verbal Pain Scores Post-gait
Verbal pain scores (0-10), lower scores represent better outcomes. Score will be obtained from patients for 1 day after surgery, post gait active and at rest.
Measured: 3 Days Post Surgery
Verbal Pain Scores Post-gait
Verbal pain scores (0-10), lower scores represent better outcomes. Score will be obtained from patients for 1 day after surgery, post gait active and at rest.
Measured: 4 Days Post Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startJan 2010
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: Drug was discontinued by manufacturer
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 Hip ArthroplastyStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Collaborators
- EKR Therapeutics, Inc
- Responsible party
- Sponsor
- Investigators
- Pamela C Nagle, M.D., Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00934661
- Sponsor's protocol ID
- IRB00006969
- Status last verified
- Sep 2018
- First submitted
- 2 Jul 2009
- Last updated
- 12 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Extended-release Epidural Morphine in Conjunction With Lumbar Plexus Block Versus Lumbar Plexus Block Alone for Total Hip Resurfacing Arthroplasty: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00934661
- Acronym / sponsor ID
- IRB00006969
- Conditions
- Hip Arthroplasty
- Keywords
- hip resurfacing, hip arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Drug was discontinued by manufacturer
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Collaborators
- EKR Therapeutics, Inc
- Study start
- Jan 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 8 Jul 2009 (estimated)
- Results
- Posted 16 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
At Wake Forest University, the investigators have been using Extended Release Epidural Morphine (EREM), since late 2004, as part of multimodal analgesia in patients having gynecologic surgeries and hip arthroplasties.
Hypothesis:
In patients undergoing a Birmingham total hip arthroplasty (BHA), low dose EREM in conjunction with lumbar plexus block (LPB) will be better than lumbar plexus block alone in increasing proportion of patients who meet discharge criteria within 24 hours.
Detailed description
Extended release epidural morphine (EREM, DepoDur®: Endo Pharmaceuticals, Chadds Ford PA) has been studied and increasingly utilized as a method to allow for the improved post-operative analgesia of epidural analgesia without infusions.
At Wake Forest University, the investigators have been using EREM, since late 2004, as part of multimodal analgesia in patients having gynecologic surgeries and hip arthroplasties. The investigators initially decreased our dosages from those recommended (15 mg for lower extremity surgery and 10-15 mg for abdominal surgery), because side effects (nausea, vomiting and hypotension) were felt to be limiting to recovery. The investigators now use 4-7.5 mg in most patients, with 7.5 mg being the exception and have achieved better results. For hip arthroplasties, the investigators currently use 4-5 mg and have performed two retrospective chart reviews on this use; both suggesting that this approach is efficacious. However, these doses have not been studied in a prospective, randomized, double blind trial. The investigators would like to evaluate the efficacy of this dose of EREM used as part of a multimodal regimen. The investigators will compare EREM 4 mg with lumbar plexus block versus lumbar plexus block alone, (providing the rest of our multimodal approach for both patients).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended Release Epidural Morphine | Experimental | Drug: Extended Release Epidural Morphine (EREM)Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline |
| Placebo Group | Placebo comparator | Drug: PlaceboThe epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A primary unilateral Birmingham hip arthroplasty
- Men and women 18-65 years
Key exclusion criteria (7 listed)
- Refusal of regional anesthesia
- Laboratory evidence of coagulopathy (platelet count less than 100,000 cells/microliter of blood, prothrombin time greater than 12.1 seconds, partial thromboplastin time greater than 30 seconds, or international normalized ratio of greater than 1.5)
- Allergy to morphine
- Obstructive sleep apnea
- Body mass index (BMI) greater than 40 kg/m2
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 |
|---|---|---|
| Extended Release Epidural Morphine (EREM)Also: DepodurA single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline | Drug | Extended Release Epidural Morphine |
| PlaceboAlso: preservative free normal saline, sodium chlorideA single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush | Drug | Placebo Group |
Primary outcome
Length of Hospital Stay After Surgery
Time frame: From surgery day to hospital discharge, up to 4 days
7 secondary outcomes
Total Opioid Consumption
Time frame: 96 hours
Patient Satisfaction Score
Time frame: 96 hours
Distance Walked at Walking Test
Time frame: 96 hours
Verbal Pain Scores Post-gait
Time frame: 1 day post surgery
Verbal Pain Scores Post-gait
Time frame: 2 Days Post Surgery
Verbal Pain Scores Post-gait
Time frame: 3 Days Post Surgery
Verbal Pain Scores Post-gait
Time frame: 4 Days Post Surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hip Arthroplasty
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Developing an Opioid Taper Intervention Before Total Joint Arthroplasty
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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.
Pamela C Nagle, M.D. principal investigator
Wake Forest University Health Sciences
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 Extended Release Epidural Morphine (EREM) in people with Hip Arthroplasty, run by Wake Forest University 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 2 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: stopped early, as of the sponsor's last update on 12 Sep 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. Some participants in this study may receive a placebo. 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 16 Jan 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?
Length of Hospital Stay After Surgery (time frame: From surgery day to hospital discharge, up to 4 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 12 Sep 2018.