Hip Arthroplasty Clinical Trial
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.
Verified date | September 2018 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 40 |
Est. completion date | March 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University | EKR Therapeutics, Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Length of Hospital Stay After Surgery | From surgery day to hospital discharge, up to 4 days | ||
Secondary | Total Opioid Consumption | 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.) | 96 hours | |
Secondary | Patient Satisfaction Score | Verbal satisfaction scores (0-10), higher scores represent better outcomes. Scores will be obtained from patients for 96 hours after surgery. | 96 hours | |
Secondary | Distance Walked at Walking Test | Distance walked at walking test. Longer distance walked represent better outcomes | 96 hours | |
Secondary | Verbal Pain Scores Post-gait | 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. | 1 day post surgery | |
Secondary | Verbal Pain Scores Post-gait | 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. | 2 Days Post Surgery | |
Secondary | Verbal Pain Scores Post-gait | 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. | 3 Days Post Surgery | |
Secondary | Verbal Pain Scores Post-gait | 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. | 4 Days Post Surgery |
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