Trial Outcomes & Findings for Adductor Canal Block for Medial Compartment Knee Arthroplasty (NCT NCT01818531)
NCT ID: NCT01818531
Last Updated: 2018-09-13
Results Overview
Comparison of verbal numerical pain scores at rest and with movement 6 hours following nerve blockade. The score range is 0-10 with higher scores denoting worse outcomes.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
150 participants
Primary outcome timeframe
6 hours post block.
Results posted on
2018-09-13
Participant Flow
Participant milestones
| Measure |
Adductor Canal Block
Patients in this arm will receive an adductor canal block prior to undergoing a medial compartment knee arthroplasty.
Adductor canal block
|
Lumbar Plexus Block
Patients in this arm will receive a lumbar plexus block prior to undergoing a medial compartment knee arthroplasty.
Lumbar plexus block
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
75
|
|
Overall Study
COMPLETED
|
74
|
73
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Adductor Canal Block
Patients in this arm will receive an adductor canal block prior to undergoing a medial compartment knee arthroplasty.
Adductor canal block
|
Lumbar Plexus Block
Patients in this arm will receive a lumbar plexus block prior to undergoing a medial compartment knee arthroplasty.
Lumbar plexus block
|
|---|---|---|
|
Overall Study
Withdrawn for case delay after block
|
1
|
0
|
|
Overall Study
Withdrawn for long-acting opioid patch
|
0
|
1
|
|
Overall Study
Withdrawn for failure to place block
|
0
|
1
|
Baseline Characteristics
Adductor Canal Block for Medial Compartment Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
Adductor Canal Block
n=74 Participants
Patients in this arm will receive an adductor canal block prior to undergoing a medial compartment knee arthroplasty.
Adductor canal block
|
Lumbar Plexus Block
n=73 Participants
Patients in this arm will receive a lumbar plexus block prior to undergoing a medial compartment knee arthroplasty.
Lumbar plexus block
|
Total
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
63 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
63 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
75 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
63 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
126 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 hours post block.Comparison of verbal numerical pain scores at rest and with movement 6 hours following nerve blockade. The score range is 0-10 with higher scores denoting worse outcomes.
Outcome measures
| Measure |
Adductor Canal Block
n=74 Participants
Patients in this arm will receive an adductor canal block prior to undergoing a medial compartment knee arthroplasty.
Adductor canal block
|
Lumbar Plexus Block
n=73 Participants
Patients in this arm will receive a lumbar plexus block prior to undergoing a medial compartment knee arthroplasty.
Lumbar plexus block
|
|---|---|---|
|
Verbal Pain Scores at 6 Hours Post Nerve Blockade.
rest
|
1 score on a scale
Standard Deviation 2
|
1.1 score on a scale
Standard Deviation 2.2
|
|
Verbal Pain Scores at 6 Hours Post Nerve Blockade.
movement
|
1.6 score on a scale
Standard Deviation 2.6
|
1.5 score on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: 6, 12, 18, and 24 hoursComparison of cumulative opioid consumption over 24 hour period between adductor canal block and lumbar plexus block.
Outcome measures
| Measure |
Adductor Canal Block
n=74 Participants
Patients in this arm will receive an adductor canal block prior to undergoing a medial compartment knee arthroplasty.
Adductor canal block
|
Lumbar Plexus Block
n=73 Participants
Patients in this arm will receive a lumbar plexus block prior to undergoing a medial compartment knee arthroplasty.
Lumbar plexus block
|
|---|---|---|
|
Opioid Consumption
6 hours
|
1.5 mg
Standard Deviation 4.5
|
2.5 mg
Standard Deviation 5.2
|
|
Opioid Consumption
12 hours
|
11 mg
Standard Deviation 14.3
|
10.3 mg
Standard Deviation 11.5
|
|
Opioid Consumption
18 hours
|
20.9 mg
Standard Deviation 26.8
|
20.7 mg
Standard Deviation 17.8
|
|
Opioid Consumption
24 hours
|
27.9 mg
Standard Deviation 38.4
|
32.1 mg
Standard Deviation 27.7
|
SECONDARY outcome
Timeframe: 24 hoursTime to first analgesic between two groups: adductor canal block and lumbar plexus block.
Outcome measures
| Measure |
Adductor Canal Block
n=74 Participants
Patients in this arm will receive an adductor canal block prior to undergoing a medial compartment knee arthroplasty.
Adductor canal block
|
Lumbar Plexus Block
n=73 Participants
Patients in this arm will receive a lumbar plexus block prior to undergoing a medial compartment knee arthroplasty.
Lumbar plexus block
|
|---|---|---|
|
Time to First Analgesic
|
601 minutes
Standard Deviation 295
|
659 minutes
Standard Deviation 366
|
SECONDARY outcome
Timeframe: 6, 12, 18, and 24 hoursOccurrence of opioid related side effects (nausea, vomiting and pruritus) between two groups: adductor canal block and lumbar plexus block.
Outcome measures
| Measure |
Adductor Canal Block
n=74 Participants
Patients in this arm will receive an adductor canal block prior to undergoing a medial compartment knee arthroplasty.
Adductor canal block
|
Lumbar Plexus Block
n=73 Participants
Patients in this arm will receive a lumbar plexus block prior to undergoing a medial compartment knee arthroplasty.
Lumbar plexus block
|
|---|---|---|
|
Opioid Related Side Effects
Nausea 6 hours
|
14 events
|
15 events
|
|
Opioid Related Side Effects
Nausea 12 hours
|
10 events
|
16 events
|
|
Opioid Related Side Effects
Nausea 18 hours
|
5 events
|
8 events
|
|
Opioid Related Side Effects
Nausea 24 hours
|
9 events
|
15 events
|
|
Opioid Related Side Effects
Vomiting 6 hours
|
6 events
|
8 events
|
|
Opioid Related Side Effects
Vomiting 12 hours
|
6 events
|
6 events
|
|
Opioid Related Side Effects
Vomiting 18 hours
|
2 events
|
3 events
|
|
Opioid Related Side Effects
Vomiting 24 hours
|
4 events
|
6 events
|
|
Opioid Related Side Effects
Pruritus 6 hours
|
11 events
|
3 events
|
|
Opioid Related Side Effects
Pruritus 12 hours
|
7 events
|
4 events
|
|
Opioid Related Side Effects
Pruritus 18 hours
|
5 events
|
5 events
|
|
Opioid Related Side Effects
Pruritus 24 hours
|
10 events
|
13 events
|
SECONDARY outcome
Timeframe: 6 hoursComparison of quadriceps motor strength at 6 hour post nerve block between two groups: adductor canal block and lumbar plexus block. The score range is 0-5, with higher scores denoting better outcomes.
Outcome measures
| Measure |
Adductor Canal Block
n=74 Participants
Patients in this arm will receive an adductor canal block prior to undergoing a medial compartment knee arthroplasty.
Adductor canal block
|
Lumbar Plexus Block
n=73 Participants
Patients in this arm will receive a lumbar plexus block prior to undergoing a medial compartment knee arthroplasty.
Lumbar plexus block
|
|---|---|---|
|
Quadriceps Motor Strength
|
4 units on a scale
Standard Deviation 1.1
|
2.5 units on a scale
Standard Deviation 1.3
|
Adverse Events
Adductor Canal Block
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
Lumbar Plexus Block
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Adductor Canal Block
n=74 participants at risk
Patients in this arm will receive an adductor canal block prior to undergoing a medial compartment knee arthroplasty.
Adductor canal block
|
Lumbar Plexus Block
n=73 participants at risk
Patients in this arm will receive a lumbar plexus block prior to undergoing a medial compartment knee arthroplasty.
Lumbar plexus block
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
33.8%
25/74 • 24 hours
|
43.8%
32/73 • 24 hours
|
|
Gastrointestinal disorders
Vomitting
|
20.3%
15/74 • 24 hours
|
21.9%
16/73 • 24 hours
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
27.0%
20/74 • 24 hours
|
21.9%
16/73 • 24 hours
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place