Low Dose Extended-release Epidural and Lumbar Plexus Block Compared to Lumbar Plexus Block for Total Hip Resurfacing

Study Overview
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Brief Summary
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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
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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).

Official Title
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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.

Conditions
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Hip Arthroplasty

Intervention / Treatment
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* Drug: Extended Release Epidural Morphine (EREM)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extended Release Epidural Morphine<br>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)<br>* A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline<br>* Other names: Depodur;|
| Placebo Comparator: Placebo Group<br>The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush | Drug: Placebo<br>* A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush<br>* Other names: sodium chloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Hospital Stay After Surgery |  | From surgery day to hospital discharge, up to 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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.) | 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. | 96 hours | 
| Distance Walked at Walking Test | Distance walked at walking test. Longer distance walked represent better outcomes | 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. | 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. | 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. | 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. | 4 Days Post Surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hip resurfacing, hip arthroplasty