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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 )

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.


Condition or disease Intervention/treatment Phase
Hip Arthroplasty Drug: Extended Release Epidural Morphine (EREM) Drug: Placebo Phase 4

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).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2010
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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
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
Placebo Comparator: Placebo Group
The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush
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



Primary Outcome Measures :
  1. Length of Hospital Stay After Surgery [ Time Frame: From surgery day to hospital discharge ]

Secondary Outcome Measures :
  1. 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.)

  2. 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.

  3. Distance Walked at Walking Test [ Time Frame: 96 hours ]
    Distance walked at walking test. Longer distance walked represent better outcomes

  4. 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.

  5. 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.

  6. 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.

  7. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00934661


Locations
United States, North Carolina
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
EKR Therapeutics, Inc
Investigators
Principal Investigator: Pamela C Nagle, M.D. Wake Forest University Health Sciences

Responsible Party: Wake Forest University
ClinicalTrials.gov Identifier: NCT00934661     History of Changes
Other Study ID Numbers: IRB00006969
First Posted: July 8, 2009    Key Record Dates
Results First Posted: January 16, 2018
Last Update Posted: January 16, 2018
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences ( Wake Forest University ):
hip resurfacing
hip arthroplasty

Additional relevant MeSH terms:
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents