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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Wake Forest School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
EKR Therapeutics, Inc
Information provided by:
Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00934661
First received: July 2, 2009
Last updated: May 18, 2011
Last verified: May 2011

July 2, 2009
May 18, 2011
January 2010
July 2012   (final data collection date for primary outcome measure)
Length of hospital stay after surgery [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00934661 on ClinicalTrials.gov Archive Site
  • Total opioid consumption [ Time Frame: 96 hours ] [ Designated as safety issue: No ]
  • Patient satisfaction score [ Time Frame: 96 hours ] [ Designated as safety issue: No ]
    Verbal satisfaction scores (0-10) will be obtained from patients for 96 hours after surgery.
  • Verbal pain scores [ Time Frame: 96 hours ] [ Designated as safety issue: No ]
    Verbal pain scores (0-10) will be obtained from patients for 96 hours after surgery.
  • Distance walked [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Total IV and oral opioid consumption, patient satisfaction scores (0-10), passive/active verbal pain ratings (0-10) at 8 hr intervals through post-operative day 4, and a standardized 6 Minute Walking Test as well as total distance for the same session [ Time Frame: 24, 48, 72, 96 hours ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Low Dose Extended-release Epidural and Lumbar Plexus Block Compared to Lumbar Plexus Block for Total Hip Resurfacing
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.

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.

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hip Arthroplasty
  • Drug: 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
    Other Name: Depodur
  • Drug: Placebo
    A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush
    Other Names:
    • preservative free normal saline
    • sodium chloride
  • Experimental: 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
    Intervention: Drug: Extended Release Epidural Morphine (EREM)
  • Placebo Comparator: Placebo Group
    The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Regina Curry, RN 336-716-4294 recurry@wfubmc.edu
United States
 
NCT00934661
IRB00006969
No
Pamela C. Nagle, M.D., Wake Forest University School of Medicine
Wake Forest School of Medicine
EKR Therapeutics, Inc
Principal Investigator: Pamela C Nagle, M.D. Wake Forest School of Medicine
Wake Forest School of Medicine
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP