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Trial record 7 of 29 for:    "Collagen Disease" | "Dexamethasone acetate"

Systemic Steroids for Peripheral Nerve Blocks

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ClinicalTrials.gov Identifier: NCT02464176
Recruitment Status : Completed
First Posted : June 8, 2015
Results First Posted : January 16, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Osteoarthritis, Hip
Interventions Drug: Dexamethasone
Drug: Bupivacaine
Drug: Epinephrine
Procedure: Lumbar Plexus Nerve Block
Drug: Saline
Enrollment 115
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.
Arm/Group Title 4 mg Dexamethasone Group 8 mg Dexamethasone Group Control Group
Hide Arm/Group Description 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. 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. 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.
Period Title: Overall Study
Started 50 50 15
Completed 50 50 15
Not Completed 0 0 0
Arm/Group Title 4 mg Dexamethasone Group 8 mg Dexamethasone Group Control Group Total
Hide Arm/Group Description

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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 50 50 15 115
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 15 participants 115 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
34
  68.0%
32
  64.0%
8
  53.3%
74
  64.3%
>=65 years
16
  32.0%
18
  36.0%
7
  46.7%
41
  35.7%
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 50 participants 50 participants 15 participants 115 participants
61
(51 to 68)
63
(56 to 71)
66
(62 to 72)
63
(57 to 71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 15 participants 115 participants
Female
20
  40.0%
27
  54.0%
5
  33.3%
52
  45.2%
Male
30
  60.0%
23
  46.0%
10
  66.7%
63
  54.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants 50 participants 15 participants 115 participants
50 50 15 115
BMI  
Median (Inter-Quartile Range)
Unit of measure:  Kg/m^2
Number Analyzed 50 participants 50 participants 15 participants 115 participants
29.8
(25.5 to 36.1)
29.3
(25.6 to 32.6)
28.3
(22.7 to 34.2)
29.3
(25.45 to 34.05)
1.Primary Outcome
Title Duration of Sensory Blockade
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 4 mg Dexamethasone Group 8 mg Dexamethasone Group Control Group
Hide Arm/Group Description:

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

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

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.

Overall Number of Participants Analyzed 50 50 15
Mean (Standard Deviation)
Unit of Measure: hours
18.5  (8) 18.1  (7.1) 19.6  (6.7)
2.Secondary Outcome
Title Time to First Analgesic Request
Hide Description Time (in minutes) will be recorded to first analgesic request following the block placement
Time Frame 30 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 4 mg Dexamethasone Group 8 mg Dexamethasone Group Control Group
Hide Arm/Group Description:

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

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

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.

Overall Number of Participants Analyzed 50 50 15
Median (Inter-Quartile Range)
Unit of Measure: minutes
474
(382 to 590)
533
(415 to 716)
432
(383 to 491)
3.Secondary Outcome
Title Total Opioid Consumption
Hide Description [Not Specified]
Time Frame 30 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 4 mg Dexamethasone Group 8 mg Dexamethasone Group Control Group
Hide Arm/Group Description:

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

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

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.

Overall Number of Participants Analyzed 50 50 15
Median (Inter-Quartile Range)
Unit of Measure: oxycodone mg equivalents
36.6
(25.0 to 55)
30
(20 to 45)
39.2
(30 to 63.3)
4.Secondary Outcome
Title Verbal Numeric Pain Score Comparisons
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 4 mg Dexamethasone Group 8 mg Dexamethasone Group Control Group
Hide Arm/Group Description:

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

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

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.

Overall Number of Participants Analyzed 49 48 15
Median (Inter-Quartile Range)
Unit of Measure: scores on a scale
3
(1 to 4)
2
(1 to 4)
3
(2 to 5)
Time Frame Each participant was specifically monitored over a 30 hour time period while in the hospital and encouraged to report and adverse events while in the hospital or after while the study was being conducted.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 4 mg Dexamethasone Group 8 mg Dexamethasone Group Control Group
Hide Arm/Group Description

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

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

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.

All-Cause Mortality
4 mg Dexamethasone Group 8 mg Dexamethasone Group Control Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
4 mg Dexamethasone Group 8 mg Dexamethasone Group Control Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
4 mg Dexamethasone Group 8 mg Dexamethasone Group Control Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%)   0/15 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. James D. Turner
Organization: Wake Forest Baptist Medical Center
Phone: 3367164998
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02464176     History of Changes
Other Study ID Numbers: IRB00032805
First Submitted: June 1, 2015
First Posted: June 8, 2015
Results First Submitted: November 15, 2017
Results First Posted: January 16, 2018
Last Update Posted: August 31, 2018