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

NCT ID: NCT00934661

Last Updated: 2018-09-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2013-03-31

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).

Conditions

Hip Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

Extended Release Epidural Morphine (EREM)

Intervention Type: DRUG

A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline

Placebo Group

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Depodur; preservative free normal saline; sodium chloride

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EKR Therapeutics, Inc

INDUSTRY

Sponsor Role: collaborator

Wake Forest University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pamela C Nagle, M.D.

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

IRB00006969

Identifier Type: -

Identifier Source: org_study_id