Low Dose Extended-release Epidural and Lumbar Plexus Block Compared to Lumbar Plexus Block for Total Hip Resurfacing
Status: | Terminated |
---|---|
Conditions: | Orthopedic |
Therapuetic Areas: | Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 9/14/2018 |
Start Date: | January 2010 |
End Date: | March 2013 |
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.
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.
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).
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).
Inclusion Criteria:
- A primary unilateral Birmingham hip arthroplasty
- Men and women 18-65 years
Exclusion Criteria:
- 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
We found this trial at
1
site
1 Medical Center Blvd
Winston-Salem, North Carolina 27103
Winston-Salem, North Carolina 27103
(336) 716-2011

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