Low Dose Extended-release Epidural and Lumbar Plexus Block Compared to Lumbar Plexus Block for Total Hip Resurfacing
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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. |
- Length of hospital stay after surgery [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- 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:
|
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 |
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| Contact: Regina Curry, RN | 336-716-4294 | recurry@wfubmc.edu |
| 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. | |
| Principal Investigator: | Pamela C Nagle, M.D. | Wake Forest University |
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 University:
|
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 June 17, 2013