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

Wake Forest University (WFU)

Status and phase: Terminated; Phase 4

Conditions: Hip Arthroplasty

Treatments: Drug: Placebo; Drug: Extended Release Epidural Morphine (EREM)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00934661

IRB00006969

Details and patient eligibility

About

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.

Full 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).

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Extended Release Epidural Morphine

Experimental group

Description:

Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline

Treatment:

Drug: Extended Release Epidural Morphine (EREM)

Placebo Group

Placebo Comparator group

Description:

The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush

Treatment:

Drug: Placebo