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
  Purpose

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 Intervention
Hip Arthroplasty
Drug: Extended Release Epidural Morphine (EREM)
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Length of hospital stay after surgery [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: January 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00934661

Contacts
Contact: Regina Curry, RN 336-716-4294 recurry@wfubmc.edu

Locations
United States, North Carolina
Wake Forest University Baptist Medical Center Recruiting
Winston Salem, North Carolina, United States, 27157
Sub-Investigator: Timothy Gruebal, M.D.         
Sub-Investigator: James C Crews, M.D.         
Sub-Investigator: John C Gerancher, M.D.         
Sub-Investigator: Robert Weller, M.D.         
Sponsors and Collaborators
Wake Forest School of Medicine
EKR Therapeutics, Inc
Investigators
Principal Investigator: Pamela C Nagle, M.D. Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Pamela C. Nagle, M.D., Wake Forest University School of Medicine
ClinicalTrials.gov Identifier: NCT00934661     History of Changes
Other Study ID Numbers: IRB00006969
Study First Received: July 2, 2009
Last Updated: May 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
hip resurfacing
hip arthroplasty

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

ClinicalTrials.gov processed this record on July 22, 2014