Trial Outcomes & Findings for Systemic Steroids for Peripheral Nerve Blocks (NCT NCT02464176)
NCT ID: NCT02464176
Last Updated: 2018-08-31
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
115 participants
Primary outcome timeframe
30 hours
Results posted on
2018-08-31
Participant Flow
Study run from June 2015 to January 2017 at Wake Forest Baptist Medical Center
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
15
|
|
Overall Study
COMPLETED
|
50
|
50
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Systemic Steroids for Peripheral Nerve Blocks
Baseline characteristics by cohort
| Measure |
4 mg Dexamethasone Group
n=50 Participants
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.
|
8 mg Dexamethasone Group
n=50 Participants
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.
|
Control Group
n=15 Participants
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.
|
Total
n=115 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Age, Continuous
|
61 years
n=5 Participants
|
63 years
n=7 Participants
|
66 years
n=5 Participants
|
63 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
50 participants
n=7 Participants
|
15 participants
n=5 Participants
|
115 participants
n=4 Participants
|
|
BMI
|
29.8 kg/m^2
n=5 Participants
|
29.3 kg/m^2
n=7 Participants
|
28.3 kg/m^2
n=5 Participants
|
29.3 kg/m^2
n=4 Participants
|
PRIMARY outcome
Timeframe: 30 hoursThe 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.
Outcome measures
| Measure |
4 mg Dexamethasone Group
n=50 Participants
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. 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
|
8 mg Dexamethasone Group
n=50 Participants
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. 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
|
Control Group
n=15 Participants
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.
|
|---|---|---|---|
|
Duration of Sensory Blockade
|
18.5 hours
Standard Deviation 8
|
18.1 hours
Standard Deviation 7.1
|
19.6 hours
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: 30 hoursTime (in minutes) will be recorded to first analgesic request following the block placement
Outcome measures
| Measure |
4 mg Dexamethasone Group
n=50 Participants
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. 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
|
8 mg Dexamethasone Group
n=50 Participants
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. 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
|
Control Group
n=15 Participants
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.
|
|---|---|---|---|
|
Time to First Analgesic Request
|
474 minutes
Interval 382.0 to 590.0
|
533 minutes
Interval 415.0 to 716.0
|
432 minutes
Interval 383.0 to 491.0
|
SECONDARY outcome
Timeframe: 30 hoursOutcome measures
| Measure |
4 mg Dexamethasone Group
n=50 Participants
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. 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
|
8 mg Dexamethasone Group
n=50 Participants
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. 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
|
Control Group
n=15 Participants
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.
|
|---|---|---|---|
|
Total Opioid Consumption
|
36.6 oxycodone mg equivalents
Interval 25.0 to 55.0
|
30 oxycodone mg equivalents
Interval 20.0 to 45.0
|
39.2 oxycodone mg equivalents
Interval 30.0 to 63.3
|
SECONDARY outcome
Timeframe: 24 hourThis 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.
Outcome measures
| Measure |
4 mg Dexamethasone Group
n=49 Participants
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. 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
|
8 mg Dexamethasone Group
n=48 Participants
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. 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
|
Control Group
n=15 Participants
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.
|
|---|---|---|---|
|
Verbal Numeric Pain Score Comparisons
|
3 scores on a scale
Interval 1.0 to 4.0
|
2 scores on a scale
Interval 1.0 to 4.0
|
3 scores on a scale
Interval 2.0 to 5.0
|
Adverse Events
4 mg Dexamethasone Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
8 mg Dexamethasone Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place