Osteoarthritis, Hip
Conditions
Keywords
Arthroplasty, Hip, Replacement, Anesthesia, Local, Anesthesia Conduction, Bupivacaine, Dexamethasone, Preanesthetic Medications, Nerve Block, Lumbar Plexus Block, Analgesia, Glucocorticoids, Local Anesthetics
Brief summary
This study will investigate the ability of systemic dexamethasone to prolong the sensory block duration for lumbar plexus nerve blockade.
Detailed description
The purpose of this randomized, double-blinded, placebo-controlled trial is to examine the equivalency of two different doses of dexamethasone when given intravenously as an adjuvant medication for postoperative pain management. Specifically, this study will investigate the prolongation of time to recovery of sensation following a lumbar plexus block in patients undergoing total hip arthroplasties. The investigators hypothesize that dexamethasone will prolong the sensory block time when compared to placebo and that similar results will be obtained in the 4 mg arm when compared to the 8 mg arm. The primary end point will be time to sensory recovery in the femoral nerve cutaneous distribution (part of the lumbar plexus) as determined by pin-prick sensation assessment. Secondary endpoints will include, but are not be limited to: time to first opioid administration, total opioid consumption over 30 hours, and rest and incident verbal numerical pain scores at 6,12,18,24 and 30 hours post block placement.
Interventions
DRUGDexamethasone
A lumbar plexus nerve block will be performed for patients undergoing hip arthroplasty. A total of 25cc's of 0.25% bupivacaine with 1:400,000 epinephrine will be administered for postoperative analgesia. Surgical anesthesia will be provided either by an intrathecal spinal block or general anesthesia. Successful blockade will be assumed if the patient has a decrease or loss of pinprick sensation in the femoral nerve distribution, which innervates the anterior thigh. If no evidence of blockade is present, testing will occur again at 30 minutes post block. Testing will be performed with a 25 gauge Whitacre needle and once present the area of testing will be marked with a surgical marking pen so that repeat sensory testing can be undertaken at that same site over the course of the study. The subjects will then receive dexamethasone (4 or 8 mg) or placebo (saline) based on arm placement.
DRUGBupivacaine
Bupivacaine will be used in lumbar plexus nerve block mixture.
DRUGEpinephrine
Epinephrine will be used in lumbar plexus nerve block mixture.
PROCEDURELumbar Plexus Nerve Block
This is the procedure that will be performed.
DRUGSaline
Patients randomized to the placebo group will receive normal saline intravenously.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
Primary elective total hip arthroplasty surgery * must be a candidate for placement of a lumbar plexus block under anatomic landmark technique using electrical stimulation * must give written informed consent for anesthesia * must also be reliable and able to give accurate verbal pain scores postoperatively
Exclusion criteria
* contraindications to regional anesthesia including, allergy to amide local anesthetics, presence of peripheral neurologic dysfunction, pre-existing coagulopathy or infection in the area of interest will be excluded. * insulin and non-insulin dependent diabetes mellitus * preoperative use of systemic corticosteroids within 30 days of surgery * chronic opioid use (defined as daily opioid dose of greater than 40 mg of oxycodone equivalents or any long-acting opioid) * pregnancy * failure to effectively place the lumbar plexus block. * known prior adverse reaction to dexamethasone (for example: psychosis) or an allergy to dexamethasone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Sensory Blockade | 30 hours | The primary outcome will be duration of sensory blockade in the distribution of the lumbar plexus as determined by pin-prick sensation as tested every two hours with pin-prick sensation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Analgesic Request | 30 hours | Time (in minutes) will be recorded to first analgesic request following the block placement |
| Total Opioid Consumption | 30 hours | — |
| Verbal Numeric Pain Score Comparisons | 24 hour | This secondary outcome includes pain scores utilizing the verbal numeric pain score scale (0 to 11). Higher values indicate worse outcomes (higher pain scores). Lower values are better. |
Countries
United States
Participant flow
Recruitment details
Study run from June 2015 to January 2017 at Wake Forest Baptist Medical Center
Pre-assignment details
Patients 18-90 years old undergoing primary elective total hip arthroplasty were eligible. Exclusion: contraindications to regional anaesthesia, peripheral neurologic dysfunction or neuropathy, diabetes mellitus, systemic corticosteroid use within 30-days of surgery, chronic opioid use, pregnancy, allergy or adverse reaction to dexamethasone.
Participants by arm
| Arm | Count |
|---|---|
| 4 mg Dexamethasone Group Following lumbar plexus nerve block administration using bupivacaine and epinephrine, 4 mg of systemic dexamethasone will be administered to this group intravenously. The volume given intravenously will be identical for all groups.
Dexamethasone: A lumbar plexus nerve block will be performed for patients undergoing hip arthroplasty. A total of 25cc's of 0.25% bupivacaine with 1:400,000 epinephrine will be administered for postoperative analgesia. Surgical anesthesia will be provided either by an intrathecal spinal block or general anesthesia. The block will be tested for block success. Testing will be performed with a 25 gauge Whitacre needle . The subjects will then receive dexamethasone (4 or 8 mg) or placebo (saline) based on arm placement.
Bupivacaine: Bupivacaine will be used in lumbar plexus nerve block mixture.
Epinephrine: Epinephrine will be used in lumbar plexus nerve block mixture.
Lumbar Plexus Nerve Block: This is the procedure that will be performed. | 50 |
| 8 mg Dexamethasone Group Following peripheral nerve block using bupivacaine and epinephrine administration, 8 mg of systemic dexamethasone will be administered to this group intravenously. The volume given intravenously will be identical for all groups.
Dexamethasone: A lumbar plexus nerve block will be performed for patients undergoing hip arthroplasty. A total of 25cc's of 0.25% bupivacaine with 1:400,000 epinephrine will be administered for postoperative analgesia. Surgical anesthesia will be provided either by an intrathecal spinal block or general anesthesia. The block will be tested for block success. Testing will be performed with a 25 gauge Whitacre needle . The subjects will then receive dexamethasone (4 or 8 mg) or placebo (saline) based on arm placement.
Bupivacaine: Bupivacaine will be used in lumbar plexus nerve block mixture.
Epinephrine: Epinephrine will be used in lumbar plexus nerve block mixture.
Lumbar Plexus Nerve Block: This is the procedure that will be performed. | 50 |
| Control Group Normal saline will be used as a placebo control group given at the same time and in the same manner as the experimental groups following peripheral nerve block administration. The volume given intravenously will be identical for all groups.
Bupivacaine: Bupivacaine will be used in lumbar plexus nerve block mixture.
Epinephrine: Epinephrine will be used in lumbar plexus nerve block mixture.
Lumbar Plexus Nerve Block: This is the procedure that will be performed.
Saline: Patients randomized to the placebo group will receive normal saline intravenously. | 15 |
| Total | 115 |
Baseline characteristics
| Characteristic | Control Group | Total | 4 mg Dexamethasone Group | 8 mg Dexamethasone Group |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 41 Participants | 16 Participants | 18 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 74 Participants | 34 Participants | 32 Participants |
| Age, Continuous | 66 years | 63 years | 61 years | 63 years |
| BMI | 28.3 kg/m^2 | 29.3 kg/m^2 | 29.8 kg/m^2 | 29.3 kg/m^2 |
| Region of Enrollment United States | 15 participants | 115 participants | 50 participants | 50 participants |
| Sex: Female, Male Female | 5 Participants | 52 Participants | 20 Participants | 27 Participants |
| Sex: Female, Male Male | 10 Participants | 63 Participants | 30 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 50 | 0 / 15 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 | 0 / 15 |
Outcome results
Primary
Duration of Sensory Blockade
The primary outcome will be duration of sensory blockade in the distribution of the lumbar plexus as determined by pin-prick sensation as tested every two hours with pin-prick sensation.
Time frame: 30 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4 mg Dexamethasone Group | Duration of Sensory Blockade | 18.5 hours | Standard Deviation 8 |
| 8 mg Dexamethasone Group | Duration of Sensory Blockade | 18.1 hours | Standard Deviation 7.1 |
| Control Group | Duration of Sensory Blockade | 19.6 hours | Standard Deviation 6.7 |
Secondary
Time to First Analgesic Request
Time (in minutes) will be recorded to first analgesic request following the block placement
Time frame: 30 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 4 mg Dexamethasone Group | Time to First Analgesic Request | 474 minutes |
| 8 mg Dexamethasone Group | Time to First Analgesic Request | 533 minutes |
| Control Group | Time to First Analgesic Request | 432 minutes |
Secondary
Total Opioid Consumption
Time frame: 30 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 4 mg Dexamethasone Group | Total Opioid Consumption | 36.6 oxycodone mg equivalents |
| 8 mg Dexamethasone Group | Total Opioid Consumption | 30 oxycodone mg equivalents |
| Control Group | Total Opioid Consumption | 39.2 oxycodone mg equivalents |
Secondary
Verbal Numeric Pain Score Comparisons
This secondary outcome includes pain scores utilizing the verbal numeric pain score scale (0 to 11). Higher values indicate worse outcomes (higher pain scores). Lower values are better.
Time frame: 24 hour
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 4 mg Dexamethasone Group | Verbal Numeric Pain Score Comparisons | 3 scores on a scale |
| 8 mg Dexamethasone Group | Verbal Numeric Pain Score Comparisons | 2 scores on a scale |
| Control Group | Verbal Numeric Pain Score Comparisons | 3 scores on a scale |