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

Phase 4

Terminated

Interventions: Drug: Extended Release Epidural Morphine (EREM)
Drug: Placebo

Brief 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.

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).

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Extended Release Epidural Morphine	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	The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush

Primary Outcome Measures

Name	Time	Method
Length of Hospital Stay After Surgery	From surgery day to hospital discharge, up to 4 days

Secondary Outcome Measures

Name	Time	Method
Total Opioid Consumption	96 hours	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.)
Patient Satisfaction Score	96 hours	Verbal satisfaction scores (0-10), higher scores represent better outcomes. Scores will be obtained from patients for 96 hours after surgery.
Distance Walked at Walking Test	96 hours	Distance walked at walking test. Longer distance walked represent better outcomes
Verbal Pain Scores Post-gait	4 Days Post Surgery	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.