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

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ClinicalTrials.gov Identifier: NCT00934661
Recruitment Status : Terminated (Drug was discontinued by manufacturer)
First Posted : July 8, 2009
Results First Posted : January 16, 2018
Last Update Posted : January 16, 2018
Sponsor:
Collaborator:
EKR Therapeutics, Inc
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

July 2, 2009
July 8, 2009
November 16, 2017
January 16, 2018
January 16, 2018
January 2010
March 2013   (Final data collection date for primary outcome measure)
Length of Hospital Stay After Surgery [ Time Frame: From surgery day to hospital discharge ]
Length of Hospital Stay After Surgery [ Time Frame: 24 hours ]
Complete list of historical versions of study NCT00934661 on ClinicalTrials.gov Archive Site
  • Total Opioid Consumption [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 96 hours ]
    Distance walked at walking test. Longer distance walked represent better outcomes
  • Verbal Pain Scores Post-gait [ Time Frame: 1 day 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.
  • Verbal Pain Scores Post-gait [ Time Frame: 2 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.
  • Verbal Pain Scores Post-gait [ Time Frame: 3 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.
  • Verbal Pain Scores Post-gait [ Time Frame: 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.
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 ]
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
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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.
 
Terminated
40
60
March 2013
March 2013   (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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00934661
IRB00006969
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Wake Forest University Health Sciences ( Wake Forest University )
Wake Forest University
EKR Therapeutics, Inc
Principal Investigator: Pamela C Nagle, M.D. Wake Forest University Health Sciences
Wake Forest University Health Sciences
December 2017

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