Clinical trial NCT00934661: Low Dose Extended-release Epidural and Lumbar Plexus Block Compared to Lumbar Plexus Block for Total Hip Resurfacing
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hip Arthroplasty
Keywords: hip resurfacing
hip arthroplasty
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: EKR Therapeutics, Inc
First posted: 2009-07-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Length of Hospital Stay After Surgery
timeFrame: From surgery day to hospital discharge, up to 4 days
Secondary outcomes:
measure: Total Opioid Consumption
timeFrame: 96 hours
measure: Patient Satisfaction Score
timeFrame: 96 hours
measure: Distance Walked at Walking Test
timeFrame: 96 hours
measure: Verbal Pain Scores Post-gait
timeFrame: 1 day post surgery
measure: Verbal Pain Scores Post-gait
timeFrame: 2 Days Post Surgery
measure: Verbal Pain Scores Post-gait
timeFrame: 3 Days Post Surgery
measure: Verbal Pain Scores Post-gait
timeFrame: 4 Days Post Surgery
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Pamela C Nagle, M.D.
role: PRINCIPAL_INVESTIGATOR
References: