Hip Arthroplasty
Conditions
Keywords
hip resurfacing, hip arthroplasty
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.
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).
Interventions
DRUGExtended 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
DRUGPlacebo
A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush
Sponsors
EKR Therapeutics, Inc
Wake Forest University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of Hospital Stay After Surgery | From surgery day to hospital discharge, up to 4 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Opioid Consumption | 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 | 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 | 96 hours | Distance walked at walking test. Longer distance walked represent better outcomes |
| Verbal Pain Scores Post-gait | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
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 | 19 |
| Placebo Group The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush
Placebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush | 20 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Failure of Combined/Spinal Epidural | 1 | 0 |
Baseline characteristics
| Characteristic | Extended Release Epidural Morphine | Placebo Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 20 Participants | 39 Participants |
| Region of Enrollment United States | 19 Participants | 20 Participants | 39 Participants |
| Sex: Female, Male Female | 8 Participants | 7 Participants | 15 Participants |
| Sex: Female, Male Male | 11 Participants | 13 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 1 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Length of Hospital Stay After Surgery
Time frame: From surgery day to hospital discharge, up to 4 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extended Release Epidural Morphine | Length of Hospital Stay After Surgery | 2.26 Days | Standard Deviation 1.29 |
| Placebo Group | Length of Hospital Stay After Surgery | 2.51 Days | Standard Deviation 2.02 |
Secondary
Distance Walked at Walking Test
Distance walked at walking test. Longer distance walked represent better outcomes
Time frame: 96 hours
Population: Different amount of observations were different at each visit. Data for Post Surgery Day 4 for the Extended Release Epidural Morphine was not collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Extended Release Epidural Morphine | Distance Walked at Walking Test | Post Surgery Day 3 | 200.0 Steps | Standard Deviation 70.7 |
| Extended Release Epidural Morphine | Distance Walked at Walking Test | Post Surgery Day 2 | 206.7 Steps | Standard Deviation 97.1 |
| Extended Release Epidural Morphine | Distance Walked at Walking Test | Post Surgery Day 1 | 168.1 Steps | Standard Deviation 164.2 |
| Placebo Group | Distance Walked at Walking Test | Post Surgery Day 4 | 100.0 Steps | Standard Deviation 141.2 |
| Placebo Group | Distance Walked at Walking Test | Post Surgery Day 2 | 143.5 Steps | Standard Deviation 97.4 |
| Placebo Group | Distance Walked at Walking Test | Post Surgery Day 1 | 109.8 Steps | Standard Deviation 117.9 |
| Placebo Group | Distance Walked at Walking Test | Post Surgery Day 3 | 175.0 Steps | Standard Deviation 132.8 |
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.
Time frame: 96 hours
Population: 17 participants in the Extended Release Epidural Morphine group and 18 participants in the placebo group provided Verbal satisfaction scores
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Extended Release Epidural Morphine | Patient Satisfaction Score | Post Day 1 Surgery | 9.12 units on a scale | Standard Deviation 1.73 |
| Extended Release Epidural Morphine | Patient Satisfaction Score | Post Day 3 Surgery | 9.06 units on a scale | Standard Deviation 1.2 |
| Extended Release Epidural Morphine | Patient Satisfaction Score | Post Day 2 Surgery | 8.76 units on a scale | Standard Deviation 1.68 |
| Extended Release Epidural Morphine | Patient Satisfaction Score | Post Day 4 Surgery | 9.18 units on a scale | Standard Deviation 1.24 |
| Extended Release Epidural Morphine | Patient Satisfaction Score | Total Mean and Standard Deviation | 9.03 units on a scale | Standard Deviation 1.46 |
| Placebo Group | Patient Satisfaction Score | Post Day 4 Surgery | 8.56 units on a scale | Standard Deviation 1.82 |
| Placebo Group | Patient Satisfaction Score | Total Mean and Standard Deviation | 8.58 units on a scale | Standard Deviation 1.49 |
| Placebo Group | Patient Satisfaction Score | Post Day 1 Surgery | 8.53 units on a scale | Standard Deviation 1.28 |
| Placebo Group | Patient Satisfaction Score | Post Day 2 Surgery | 8.94 units on a scale | Standard Deviation 1.29 |
| Placebo Group | Patient Satisfaction Score | Post Day 3 Surgery | 8.33 units on a scale | Standard Deviation 1.57 |
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.)
Time frame: 96 hours
Population: Data not collected on Extended Release Epidural Morphine group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Group | Total Opioid Consumption | 10.5 mg | Standard Deviation 1.8 |
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.
Time frame: 4 Days Post Surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Extended Release Epidural Morphine | Verbal Pain Scores Post-gait | Pain Score Active | 3.59 units on a scale | Standard Deviation 2.15 |
| Extended Release Epidural Morphine | Verbal Pain Scores Post-gait | Pain Score at Rest | 1.88 units on a scale | Standard Deviation 2.26 |
| Placebo Group | Verbal Pain Scores Post-gait | Pain Score Active | 5.00 units on a scale | Standard Deviation 2.56 |
| Placebo Group | Verbal Pain Scores Post-gait | Pain Score at Rest | 2.94 units on a scale | Standard Deviation 2.32 |
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.
Time frame: 1 day post surgery
Population: 16 participants were analyzed in both the Extended Release Epidural Morphine and the Placebo Group for active pain scores. 17 participants overall were analyzed for the Extended Release Epidural Morphine and 18 participants overall were analyzed for the Placebo Group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Extended Release Epidural Morphine | Verbal Pain Scores Post-gait | Pain Score at Rest | 2.35 units on a scale | Standard Deviation 2.5 |
| Extended Release Epidural Morphine | Verbal Pain Scores Post-gait | Pain Score Active | 3.44 units on a scale | Standard Deviation 2.94 |
| Placebo Group | Verbal Pain Scores Post-gait | Pain Score Active | 7.16 units on a scale | Standard Deviation 2.13 |
| Placebo Group | Verbal Pain Scores Post-gait | Pain Score at Rest | 3.58 units on a scale | Standard Deviation 2.41 |
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.
Time frame: 2 Days Post Surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Extended Release Epidural Morphine | Verbal Pain Scores Post-gait | Pain Score Active | 5.29 units on a scale | Standard Deviation 2.23 |
| Extended Release Epidural Morphine | Verbal Pain Scores Post-gait | Pain Score at Rest | 2.35 units on a scale | Standard Deviation 1.41 |
| Placebo Group | Verbal Pain Scores Post-gait | Pain Score Active | 5.24 units on a scale | Standard Deviation 2.28 |
| Placebo Group | Verbal Pain Scores Post-gait | Pain Score at Rest | 2.41 units on a scale | Standard Deviation 1.58 |
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.
Time frame: 3 Days Post Surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Extended Release Epidural Morphine | Verbal Pain Scores Post-gait | Pain Score Active | 4.18 units on a scale | Standard Deviation 2.48 |
| Extended Release Epidural Morphine | Verbal Pain Scores Post-gait | Pain Score at Rest | 2.59 units on a scale | Standard Deviation 2.29 |
| Placebo Group | Verbal Pain Scores Post-gait | Pain Score Active | 5.06 units on a scale | Standard Deviation 2.29 |
| Placebo Group | Verbal Pain Scores Post-gait | Pain Score at Rest | 2.78 units on a scale | Standard Deviation 2.05 |