Trial Outcomes & Findings for Optimal Location of Nerve Block to Minimize Perioperative Opioid Administration in ACL Surgery: Comparing True Adductor Canal to Proximal Block (NCT NCT03401450)
NCT ID: NCT03401450
Last Updated: 2023-07-14
Results Overview
Amount of morphine equivalents administered intraoperatively in 24 hours
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
69 participants
Primary outcome timeframe
24 Hours
Results posted on
2023-07-14
Participant Flow
Participant milestones
| Measure |
ACB Within True AC With Bupivacaine
The patients will receive an ultrasound-guided single injection adductor canal block with 20 mL of 0.5% bupivacaine
ACB within true AC with bupivacaine 0.5% 20cc: The adductor canal block (ACB) is more commonly being used to provide post-operative analgesia since it provides a sensory block with minimal motor block.
|
ACB Proximal to True AC With Bupivacaine
The patients will receive an ultrasound-guided single injection femoral triangle block with 20 mL of 0.5% bupivacaine
ACB proximal to true AC with bupivacaine 0.5% 20cc: Patients will receive ultra-sound guided single femoral triangle block injection with 20 mL of 0.5% bupivicaine
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
36
|
|
Overall Study
COMPLETED
|
21
|
23
|
|
Overall Study
NOT COMPLETED
|
12
|
13
|
Reasons for withdrawal
| Measure |
ACB Within True AC With Bupivacaine
The patients will receive an ultrasound-guided single injection adductor canal block with 20 mL of 0.5% bupivacaine
ACB within true AC with bupivacaine 0.5% 20cc: The adductor canal block (ACB) is more commonly being used to provide post-operative analgesia since it provides a sensory block with minimal motor block.
|
ACB Proximal to True AC With Bupivacaine
The patients will receive an ultrasound-guided single injection femoral triangle block with 20 mL of 0.5% bupivacaine
ACB proximal to true AC with bupivacaine 0.5% 20cc: Patients will receive ultra-sound guided single femoral triangle block injection with 20 mL of 0.5% bupivicaine
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
6
|
|
Overall Study
Anesthesia plan changed
|
2
|
2
|
|
Overall Study
Did not complete medication diary
|
4
|
2
|
|
Overall Study
post surgery medication change
|
2
|
1
|
|
Overall Study
Cancelled surgery
|
0
|
2
|
Baseline Characteristics
Optimal Location of Nerve Block to Minimize Perioperative Opioid Administration in ACL Surgery: Comparing True Adductor Canal to Proximal Block
Baseline characteristics by cohort
| Measure |
ACB Within True AC With Bupivacaine
n=33 Participants
The patients will receive an ultrasound-guided single injection adductor canal block with 20 mL of 0.5% bupivacaine
ACB within true AC with bupivacaine 0.5% 20cc: The adductor canal block (ACB) is more commonly being used to provide post-operative analgesia since it provides a sensory block with minimal motor block.
|
ACB Proximal to True AC With Bupivacaine
n=36 Participants
The patients will receive an ultrasound-guided single injection femoral triangle block with 20 mL of 0.5% bupivacaine
ACB proximal to true AC with bupivacaine 0.5% 20cc: Patients will receive ultra-sound guided single femoral triangle block injection with 20 mL of 0.5% bupivicaine
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-25 years
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Customized
26-35 years
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age, Customized
36-45 years
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Customized
46-55 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Customized
56-65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
36 participants
n=7 Participants
|
69 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 HoursAmount of morphine equivalents administered intraoperatively in 24 hours
Outcome measures
| Measure |
ACB Within True AC With Bupivacaine
n=21 Participants
The patients will receive an ultrasound-guided single injection adductor canal block with 20 mL of 0.5% bupivacaine
ACB within true AC with bupivacaine 0.5% 20cc: The adductor canal block (ACB) is more commonly being used to provide post-operative analgesia since it provides a sensory block with minimal motor block.
|
ACB Proximal to True AC With Bupivacaine
n=23 Participants
The patients will receive an ultrasound-guided single injection femoral triangle block with 20 mL of 0.5% bupivacaine
ACB proximal to true AC with bupivacaine 0.5% 20cc: Patients will receive ultra-sound guided single femoral triangle block injection with 20 mL of 0.5% bupivicaine
|
|---|---|---|
|
Total Opioid Consumption Intraop Measured by Amounts of Morphine Equivalents
|
23.21 milligrams of morphine equivalents
Standard Deviation 12.23
|
18.93 milligrams of morphine equivalents
Standard Deviation 9.34
|
PRIMARY outcome
Timeframe: 24 HoursAmount of morphine equivalents administered postoperatively in 24 hours
Outcome measures
| Measure |
ACB Within True AC With Bupivacaine
n=21 Participants
The patients will receive an ultrasound-guided single injection adductor canal block with 20 mL of 0.5% bupivacaine
ACB within true AC with bupivacaine 0.5% 20cc: The adductor canal block (ACB) is more commonly being used to provide post-operative analgesia since it provides a sensory block with minimal motor block.
|
ACB Proximal to True AC With Bupivacaine
n=23 Participants
The patients will receive an ultrasound-guided single injection femoral triangle block with 20 mL of 0.5% bupivacaine
ACB proximal to true AC with bupivacaine 0.5% 20cc: Patients will receive ultra-sound guided single femoral triangle block injection with 20 mL of 0.5% bupivicaine
|
|---|---|---|
|
Total Opioid Consumption Postop Measured by Amounts of Morphine Equivalents
|
10 mg of morphine equivalents
Standard Deviation 6.79
|
13.18 mg of morphine equivalents
Standard Deviation 7.57
|
PRIMARY outcome
Timeframe: 24 hoursOutcome measures
| Measure |
ACB Within True AC With Bupivacaine
n=21 Participants
The patients will receive an ultrasound-guided single injection adductor canal block with 20 mL of 0.5% bupivacaine
ACB within true AC with bupivacaine 0.5% 20cc: The adductor canal block (ACB) is more commonly being used to provide post-operative analgesia since it provides a sensory block with minimal motor block.
|
ACB Proximal to True AC With Bupivacaine
n=23 Participants
The patients will receive an ultrasound-guided single injection femoral triangle block with 20 mL of 0.5% bupivacaine
ACB proximal to true AC with bupivacaine 0.5% 20cc: Patients will receive ultra-sound guided single femoral triangle block injection with 20 mL of 0.5% bupivicaine
|
|---|---|---|
|
Side Effects Such as Nausea, Itching, Constipation.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: This measure was not measured/assessed in study participants; the orthopedic surgeon's office did not perform this test in the clinic at any point of the study.
Outcome measures
Outcome data not reported
Adverse Events
ACB Within True AC With Bupivacaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ACB Proximal to True AC With Bupivacaine
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