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NCT00934661
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.
Phase 4 trial testing Extended Release Epidural Morphine (EREM) in Hip Arthroplasty in 40 participants. Terminated before completion.
1 March 2013
Quick facts
| Lead sponsor | Wake Forest University |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 1 January 2010 |
| Primary completion | 1 March 2013 |
| Estimated completion | 1 March 2013 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Extended Release Epidural Morphine (EREM) — full drug profile →
- Placebo
Conditions studied
- Hip Arthroplasty — all drugs for Hip Arthroplasty →
Sponsor
Wake Forest University
Who can join
Adults 18 to 65, any sex, with Hip Arthroplasty. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Length of Hospital Stay After Surgery
Time frame: From surgery day to hospital discharge, up to 4 days
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT00934661
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other recruiting trials for Hip Arthroplasty
Currently open trials in the same condition.
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- NCT07017192 — OPPOSED (anteriOr hiP arthroPlasty regiOnal aneSthEsia stuDy) Study · NA · recruiting
Other Wake Forest University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00934661 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Wake Forest University
- Last refreshed: 10 September 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00934661.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing