Trial Outcomes & Findings for Comparing Subsartorial Saphenous Nerve Blocks With and Without Dexamethasone for Anterior Cruciate Ligament Reconstruction (NCT NCT01586806)
NCT ID: NCT01586806
Last Updated: 2016-11-28
Results Overview
After discharge, patients will be called and given instructions to help determine length of time of analgesia in the saphenous nerve distribution.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
195 participants
Primary outcome timeframe
Up to 2 days following surgery
Results posted on
2016-11-28
Participant Flow
Participant milestones
| Measure |
Control
Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
|
Dexamethasone 1 mg
Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
|
Dexamethasone 4 mg
Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
|
|---|---|---|---|
|
Overall Study
STARTED
|
65
|
65
|
65
|
|
Overall Study
COMPLETED
|
62
|
61
|
63
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
2
|
Reasons for withdrawal
| Measure |
Control
Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
|
Dexamethasone 1 mg
Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
|
Dexamethasone 4 mg
Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
2
|
Baseline Characteristics
Comparing Subsartorial Saphenous Nerve Blocks With and Without Dexamethasone for Anterior Cruciate Ligament Reconstruction
Baseline characteristics by cohort
| Measure |
Control
n=62 Participants
Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
|
Dexamethasone 1 mg
n=61 Participants
Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
|
Dexamethasone 4 mg
n=63 Participants
Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
|
Total
n=186 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
27 years
STANDARD_DEVIATION 10 • n=5 Participants
|
26 years
STANDARD_DEVIATION 8 • n=7 Participants
|
27 years
STANDARD_DEVIATION 10 • n=5 Participants
|
26 years
STANDARD_DEVIATION 9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
121 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
62 participants
n=5 Participants
|
61 participants
n=7 Participants
|
63 participants
n=5 Participants
|
186 participants
n=4 Participants
|
|
Body Mass Index
|
24 kg/(m^2)
STANDARD_DEVIATION 3 • n=5 Participants
|
24 kg/(m^2)
STANDARD_DEVIATION 4 • n=7 Participants
|
25 kg/(m^2)
STANDARD_DEVIATION 3 • n=5 Participants
|
25 kg/(m^2)
STANDARD_DEVIATION 4 • n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 2 days following surgeryAfter discharge, patients will be called and given instructions to help determine length of time of analgesia in the saphenous nerve distribution.
Outcome measures
| Measure |
Control
n=62 Participants
Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
|
Dexamethasone 1 mg
n=61 Participants
Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
|
Dexamethasone 4 mg
n=63 Participants
Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
|
|---|---|---|---|
|
Patient-perceived Duration of Analgesia
|
33 hours
Interval 28.4 to 37.3
|
41 hours
Interval 32.4 to 50.9
|
46.5 hours
Interval 35.8 to 48.9
|
SECONDARY outcome
Timeframe: Postoperative day 1Patients will be asked to rate, on a scale of 0-10, their pain while at rest. 0 indicates no pain, and 10 indicates the worst pain imaginable.
Outcome measures
| Measure |
Control
n=62 Participants
Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
|
Dexamethasone 1 mg
n=61 Participants
Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
|
Dexamethasone 4 mg
n=63 Participants
Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
|
|---|---|---|---|
|
NRS (Numerical Rating Scale) Pain Scores
|
3 units on a scale
Interval 2.0 to 5.0
|
3 units on a scale
Interval 1.0 to 4.0
|
2 units on a scale
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: Up to 2 days following surgeryPatients will be asked to rate satisfaction on a scale of 0-10 (0=completely dissatisfied, 10=completely satisfied);
Outcome measures
| Measure |
Control
n=62 Participants
Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
|
Dexamethasone 1 mg
n=61 Participants
Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
|
Dexamethasone 4 mg
n=63 Participants
Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
|
|---|---|---|---|
|
Patient Satisfaction
|
8 units on a scale
Interval 6.0 to 9.0
|
8 units on a scale
Interval 6.0 to 9.0
|
9 units on a scale
Interval 8.0 to 10.0
|
SECONDARY outcome
Timeframe: Up to 2 days following surgeryData collector will record how many opioids (i.e. Percocet, Vicodin) the patient has used since discharge.
Outcome measures
| Measure |
Control
n=62 Participants
Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
|
Dexamethasone 1 mg
n=61 Participants
Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
|
Dexamethasone 4 mg
n=63 Participants
Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
|
|---|---|---|---|
|
Postoperative Morphine Consumption
|
45 milligrams
Interval 26.3 to 60.0
|
30 milligrams
Interval 22.5 to 60.0
|
30 milligrams
Interval 15.0 to 52.5
|
SECONDARY outcome
Timeframe: Up to 2 days following surgeryData collector will administer the Opioid-Related Distress Scale (OR-SDS) to determine if patients experience any opioid-related side effects (i.e. drowsiness). The OR-SDS score is on a scale of 0 to 4, with a higher number representing more severe symptoms.
Outcome measures
| Measure |
Control
n=62 Participants
Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
|
Dexamethasone 1 mg
n=61 Participants
Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
|
Dexamethasone 4 mg
n=63 Participants
Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
|
|---|---|---|---|
|
Opioid-Related Side Effects (Drowsiness)
|
1.1 units on a scale
Interval 0.0 to 1.6
|
1 units on a scale
Interval 0.0 to 1.7
|
0 units on a scale
Interval 0.0 to 1.4
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dexamethasone 1 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dexamethasone 4 mg
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