Low Dose Extended-release Epidural and Lumbar Plexus Block Compared to Lumbar Plexus Block for Total Hip Resurfacing
Recruitment status was: Recruiting
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.
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.
|Hip Arthroplasty||Drug: Extended Release Epidural Morphine (EREM) Drug: Placebo|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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.|
- Length of hospital stay after surgery [ Time Frame: 24 hours ]
- Total opioid consumption [ Time Frame: 96 hours ]
- Patient satisfaction score [ Time Frame: 96 hours ]Verbal satisfaction scores (0-10) will be obtained from patients for 96 hours after surgery.
- Verbal pain scores [ Time Frame: 96 hours ]Verbal pain scores (0-10) will be obtained from patients for 96 hours after surgery.
- Distance walked [ Time Frame: 48 hours ]
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||July 2012|
|Estimated Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Experimental: Extended Release Epidural Morphine
Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline
Drug: Extended Release Epidural Morphine (EREM)
A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline
Other Name: Depodur
Placebo Comparator: Placebo Group
The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush
A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00934661
|Contact: Regina Curry, RNfirstname.lastname@example.org|
|United States, North Carolina|
|Wake Forest University Baptist Medical Center||Recruiting|
|Winston Salem, North Carolina, United States, 27157|
|Sub-Investigator: Timothy Gruebal, M.D.|
|Sub-Investigator: James C Crews, M.D.|
|Sub-Investigator: John C Gerancher, M.D.|
|Sub-Investigator: Robert Weller, M.D.|
|Principal Investigator:||Pamela C Nagle, M.D.||Wake Forest University Health Sciences|