Trial Outcomes & Findings for Genicular Nerve Blocks for Anterior Cruciate Ligament Knee Surgery (NCT NCT05720949)
NCT ID: NCT05720949
Last Updated: 2026-01-26
Results Overview
Intravenous and Oral opioid consumption at 24 hours after recovery room entry will be recorded. The average consumption will be reported in morphine milligram equivalents.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
192 participants
Primary outcome timeframe
Post-operative care unit (PACU) arrival time to 24 hours
Results posted on
2026-01-26
Participant Flow
Enrollment occurred between January 12, 2023 and November 25, 2024 in the preoperative holding area of the Hospital for Special Surgery West Side Ambulatory Surgery Center.
Participant milestones
| Measure |
Group 1 - Control
Patients randomized to this group will receive an adductor canal block (ACB) and Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) nerve block.
|
Group 2 - Intervention
Patients randomized to this group will receive an adductor canal block (ACB), Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) nerve block, and the genicular nerve block (intervention).
The genicular nerve block is a total of 20cc of 0.25% bupivacaine with 2mg of preservative free dexamethasone applied to the superomedial genicular nerve, superolateral genicular nerve, inferomedial genicular nerve, and nerve to vastus intermedius.
Genicular Nerve Block with bupivacaine and preservative free dexamethasone: A genicular nerve block is a peripheral nerve block that temporarily anesthetizes the sensory terminal branches innervating the knee joint by injecting local anesthesia. This results in anesthesia of the anterior compartment of the knee.
The genicular nerve block consists of 20cc of 0.25% bupivacaine with 2mg of preservative free dexamethasone and will be applied to the superomedial genicular nerve, superolateral genicular nerve, inferomedial genicular nerve, and nerve to vastus intermedius.
Bupivacaine - Drug class: Sodium channel blocker
Dexamethasone - Drug class: Glucocorticoid
|
|---|---|---|
|
Overall Study
STARTED
|
96
|
96
|
|
Overall Study
COMPLETED
|
85
|
82
|
|
Overall Study
NOT COMPLETED
|
11
|
14
|
Reasons for withdrawal
| Measure |
Group 1 - Control
Patients randomized to this group will receive an adductor canal block (ACB) and Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) nerve block.
|
Group 2 - Intervention
Patients randomized to this group will receive an adductor canal block (ACB), Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) nerve block, and the genicular nerve block (intervention).
The genicular nerve block is a total of 20cc of 0.25% bupivacaine with 2mg of preservative free dexamethasone applied to the superomedial genicular nerve, superolateral genicular nerve, inferomedial genicular nerve, and nerve to vastus intermedius.
Genicular Nerve Block with bupivacaine and preservative free dexamethasone: A genicular nerve block is a peripheral nerve block that temporarily anesthetizes the sensory terminal branches innervating the knee joint by injecting local anesthesia. This results in anesthesia of the anterior compartment of the knee.
The genicular nerve block consists of 20cc of 0.25% bupivacaine with 2mg of preservative free dexamethasone and will be applied to the superomedial genicular nerve, superolateral genicular nerve, inferomedial genicular nerve, and nerve to vastus intermedius.
Bupivacaine - Drug class: Sodium channel blocker
Dexamethasone - Drug class: Glucocorticoid
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
11
|
13
|
Baseline Characteristics
One patient withdrew in the intervention group.
Baseline characteristics by cohort
| Measure |
Group 1 - Control
n=96 Participants
Patients randomized to this group will receive an adductor canal block (ACB) and Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) nerve block.
|
Group 2 - Intervention
n=95 Participants
Patients randomized to this group will receive an adductor canal block (ACB), Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) nerve block, and the genicular nerve block (intervention).
The genicular nerve block is a total of 20cc of 0.25% bupivacaine with 2mg of preservative free dexamethasone applied to the superomedial genicular nerve, superolateral genicular nerve, inferomedial genicular nerve, and nerve to vastus intermedius.
Genicular Nerve Block with bupivacaine and preservative free dexamethasone: A genicular nerve block is a peripheral nerve block that temporarily anesthetizes the sensory terminal branches innervating the knee joint by injecting local anesthesia. This results in anesthesia of the anterior compartment of the knee.
The genicular nerve block consists of 20cc of 0.25% bupivacaine with 2mg of preservative free dexamethasone and will be applied to the superomedial genicular nerve, superolateral genicular nerve, inferomedial genicular nerve, and nerve to vastus intermedius.
Bupivacaine - Drug class: Sodium channel blocker
Dexamethasone - Drug class: Glucocorticoid
|
Total
n=191 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.51 years
n=41 Participants • One patient withdrew in the intervention group.
|
26.03 years
n=1581 Participants • One patient withdrew in the intervention group.
|
26.48 years
n=4626 Participants • One patient withdrew in the intervention group.
|
|
Sex: Female, Male
Female
|
39 Participants
n=41 Participants • One patient withdrew in the intervention group.
|
37 Participants
n=1581 Participants • One patient withdrew in the intervention group.
|
76 Participants
n=4626 Participants • One patient withdrew in the intervention group.
|
|
Sex: Female, Male
Male
|
57 Participants
n=41 Participants • One patient withdrew in the intervention group.
|
58 Participants
n=1581 Participants • One patient withdrew in the intervention group.
|
115 Participants
n=4626 Participants • One patient withdrew in the intervention group.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=41 Participants • One patient withdrew in the intervention group.
|
13 Participants
n=1581 Participants • One patient withdrew in the intervention group.
|
25 Participants
n=4626 Participants • One patient withdrew in the intervention group.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
81 Participants
n=41 Participants • One patient withdrew in the intervention group.
|
80 Participants
n=1581 Participants • One patient withdrew in the intervention group.
|
161 Participants
n=4626 Participants • One patient withdrew in the intervention group.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=41 Participants • One patient withdrew in the intervention group.
|
2 Participants
n=1581 Participants • One patient withdrew in the intervention group.
|
5 Participants
n=4626 Participants • One patient withdrew in the intervention group.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=41 Participants • One patient withdrew from the intervention group.
|
0 Participants
n=1581 Participants • One patient withdrew from the intervention group.
|
2 Participants
n=4626 Participants • One patient withdrew from the intervention group.
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=41 Participants • One patient withdrew from the intervention group.
|
14 Participants
n=1581 Participants • One patient withdrew from the intervention group.
|
31 Participants
n=4626 Participants • One patient withdrew from the intervention group.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants • One patient withdrew from the intervention group.
|
0 Participants
n=1581 Participants • One patient withdrew from the intervention group.
|
0 Participants
n=4626 Participants • One patient withdrew from the intervention group.
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=41 Participants • One patient withdrew from the intervention group.
|
2 Participants
n=1581 Participants • One patient withdrew from the intervention group.
|
7 Participants
n=4626 Participants • One patient withdrew from the intervention group.
|
|
Race (NIH/OMB)
White
|
59 Participants
n=41 Participants • One patient withdrew from the intervention group.
|
63 Participants
n=1581 Participants • One patient withdrew from the intervention group.
|
122 Participants
n=4626 Participants • One patient withdrew from the intervention group.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants • One patient withdrew from the intervention group.
|
0 Participants
n=1581 Participants • One patient withdrew from the intervention group.
|
0 Participants
n=4626 Participants • One patient withdrew from the intervention group.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=41 Participants • One patient withdrew from the intervention group.
|
16 Participants
n=1581 Participants • One patient withdrew from the intervention group.
|
29 Participants
n=4626 Participants • One patient withdrew from the intervention group.
|
|
Body Mass Index
|
23.95 kg/m^2
n=41 Participants • One patient withdrew from the intervention group.
|
24.58 kg/m^2
n=1581 Participants • One patient withdrew from the intervention group.
|
24.27 kg/m^2
n=4626 Participants • One patient withdrew from the intervention group.
|
PRIMARY outcome
Timeframe: Post-operative care unit (PACU) arrival time to 24 hoursPopulation: Participants were lost to follow up in both groups.
Intravenous and Oral opioid consumption at 24 hours after recovery room entry will be recorded. The average consumption will be reported in morphine milligram equivalents.
Outcome measures
| Measure |
Group 1 - Control
n=89 Participants
Patients randomized to this group will receive an adductor canal block (ACB) and Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) nerve block.
|
Group 2 - Intervention
n=86 Participants
Patients randomized to this group will receive an adductor canal block (ACB), Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) nerve block, and the genicular nerve block (intervention).
The genicular nerve block is a total of 20cc of 0.25% bupivacaine with 2mg of preservative free dexamethasone applied to the superomedial genicular nerve, superolateral genicular nerve, inferomedial genicular nerve, and nerve to vastus intermedius.
Genicular Nerve Block with bupivacaine and preservative free dexamethasone: A genicular nerve block is a peripheral nerve block that temporarily anesthetizes the sensory terminal branches innervating the knee joint by injecting local anesthesia. This results in anesthesia of the anterior compartment of the knee.
The genicular nerve block consists of 20cc of 0.25% bupivacaine with 2mg of preservative free dexamethasone and will be applied to the superomedial genicular nerve, superolateral genicular nerve, inferomedial genicular nerve, and nerve to vastus intermedius.
Bupivacaine - Drug class: Sodium channel blocker
Dexamethasone - Drug class: Glucocorticoid
|
|---|---|---|
|
Mean Opioid Consumption at 24 Hours
|
21.5 morphine milligram equivalents
Interval 0.0 to 67.5
|
19.9 morphine milligram equivalents
Interval 0.0 to 97.5
|
SECONDARY outcome
Timeframe: PACU(PACU arrival time to removal from board), 48,72,96,168 hours after time zero (PACU arrival time)Population: At each time point, patients were lost to follow up.
Opioid consumption up to 168 hours after surgery will be recorded from the medical record and patient reported phone calls Opioid consumption in morphine milligram equivalents will be calculated and reported for each time point.
Outcome measures
| Measure |
Group 1 - Control
n=96 Participants
Patients randomized to this group will receive an adductor canal block (ACB) and Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) nerve block.
|
Group 2 - Intervention
n=95 Participants
Patients randomized to this group will receive an adductor canal block (ACB), Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) nerve block, and the genicular nerve block (intervention).
The genicular nerve block is a total of 20cc of 0.25% bupivacaine with 2mg of preservative free dexamethasone applied to the superomedial genicular nerve, superolateral genicular nerve, inferomedial genicular nerve, and nerve to vastus intermedius.
Genicular Nerve Block with bupivacaine and preservative free dexamethasone: A genicular nerve block is a peripheral nerve block that temporarily anesthetizes the sensory terminal branches innervating the knee joint by injecting local anesthesia. This results in anesthesia of the anterior compartment of the knee.
The genicular nerve block consists of 20cc of 0.25% bupivacaine with 2mg of preservative free dexamethasone and will be applied to the superomedial genicular nerve, superolateral genicular nerve, inferomedial genicular nerve, and nerve to vastus intermedius.
Bupivacaine - Drug class: Sodium channel blocker
Dexamethasone - Drug class: Glucocorticoid
|
|---|---|---|
|
Opioid Consumption
48 hours
|
15 morphine milligram equivalents
Interval 0.0 to 45.0
|
11.25 morphine milligram equivalents
Interval 0.0 to 60.0
|
|
Opioid Consumption
72 hours
|
7.5 morphine milligram equivalents
Interval 0.0 to 52.5
|
0 morphine milligram equivalents
Interval 0.0 to 60.0
|
|
Opioid Consumption
96 hours
|
0 morphine milligram equivalents
Interval 0.0 to 33.75
|
0 morphine milligram equivalents
Interval 0.0 to 60.0
|
|
Opioid Consumption
168 hours
|
0 morphine milligram equivalents
Interval 0.0 to 15.0
|
0 morphine milligram equivalents
Interval 0.0 to 22.5
|
|
Opioid Consumption
PACU
|
7.5 morphine milligram equivalents
Interval 0.0 to 30.0
|
7.5 morphine milligram equivalents
Interval 0.0 to 30.0
|
SECONDARY outcome
Timeframe: PACU (60 minutes after PACU arrival time), 24,48,72,96,168 hours after time zero (PACU arrival time)Population: At each time point, patients were lost to follow up.
Patient scores at rest and with movement will be recorded. Scale of 0 to 10, with 0 meaning "no pain" and 10 meaning "worst pain imaginable". Lower score means less pain, higher score means greater pain.
Outcome measures
| Measure |
Group 1 - Control
n=96 Participants
Patients randomized to this group will receive an adductor canal block (ACB) and Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) nerve block.
|
Group 2 - Intervention
n=95 Participants
Patients randomized to this group will receive an adductor canal block (ACB), Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) nerve block, and the genicular nerve block (intervention).
The genicular nerve block is a total of 20cc of 0.25% bupivacaine with 2mg of preservative free dexamethasone applied to the superomedial genicular nerve, superolateral genicular nerve, inferomedial genicular nerve, and nerve to vastus intermedius.
Genicular Nerve Block with bupivacaine and preservative free dexamethasone: A genicular nerve block is a peripheral nerve block that temporarily anesthetizes the sensory terminal branches innervating the knee joint by injecting local anesthesia. This results in anesthesia of the anterior compartment of the knee.
The genicular nerve block consists of 20cc of 0.25% bupivacaine with 2mg of preservative free dexamethasone and will be applied to the superomedial genicular nerve, superolateral genicular nerve, inferomedial genicular nerve, and nerve to vastus intermedius.
Bupivacaine - Drug class: Sodium channel blocker
Dexamethasone - Drug class: Glucocorticoid
|
|---|---|---|
|
Numeric Rating Scale (NRS) Pain Scores
PACU-rest
|
3 score on a scale
Interval 0.0 to 8.0
|
2 score on a scale
Interval 0.0 to 8.0
|
|
Numeric Rating Scale (NRS) Pain Scores
PACU-movement
|
4 score on a scale
Interval 0.0 to 8.0
|
2.5 score on a scale
Interval 0.0 to 8.0
|
|
Numeric Rating Scale (NRS) Pain Scores
24 hours-rest
|
3 score on a scale
Interval 0.0 to 10.0
|
3 score on a scale
Interval 0.0 to 9.0
|
|
Numeric Rating Scale (NRS) Pain Scores
24 hours-movement
|
5 score on a scale
Interval 0.0 to 10.0
|
5 score on a scale
Interval 0.0 to 10.0
|
|
Numeric Rating Scale (NRS) Pain Scores
48 hours-rest
|
3 score on a scale
Interval 0.0 to 10.0
|
3 score on a scale
Interval 1.0 to 8.0
|
|
Numeric Rating Scale (NRS) Pain Scores
48 hours-movement
|
5 score on a scale
Interval 0.0 to 10.0
|
5 score on a scale
Interval 0.0 to 10.0
|
|
Numeric Rating Scale (NRS) Pain Scores
72 hours-rest
|
3 score on a scale
Interval 0.0 to 9.0
|
2 score on a scale
Interval 0.0 to 7.0
|
|
Numeric Rating Scale (NRS) Pain Scores
72 hours-movement
|
4 score on a scale
Interval 0.0 to 9.0
|
4 score on a scale
Interval 0.0 to 9.0
|
|
Numeric Rating Scale (NRS) Pain Scores
96 hours-rest
|
2 score on a scale
Interval 0.0 to 9.0
|
2 score on a scale
Interval 0.0 to 7.0
|
|
Numeric Rating Scale (NRS) Pain Scores
96 hours-movement
|
4 score on a scale
Interval 0.0 to 10.0
|
4 score on a scale
Interval 1.0 to 8.0
|
|
Numeric Rating Scale (NRS) Pain Scores
168 hours-rest
|
1 score on a scale
Interval 0.0 to 9.0
|
1 score on a scale
Interval 0.0 to 7.0
|
|
Numeric Rating Scale (NRS) Pain Scores
168 hours-movement
|
3 score on a scale
Interval 0.0 to 9.0
|
3 score on a scale
Interval 0.0 to 8.0
|
SECONDARY outcome
Timeframe: sum of opioid used from 0-24 hours, 0-48 hours, and 0-72 hours, 0-96 hours post-operativelyPopulation: At each time point, patients were lost to follow up.
Total opioid consumption will be recorded up to 96 hours after surgery.
Outcome measures
| Measure |
Group 1 - Control
n=96 Participants
Patients randomized to this group will receive an adductor canal block (ACB) and Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) nerve block.
|
Group 2 - Intervention
n=95 Participants
Patients randomized to this group will receive an adductor canal block (ACB), Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) nerve block, and the genicular nerve block (intervention).
The genicular nerve block is a total of 20cc of 0.25% bupivacaine with 2mg of preservative free dexamethasone applied to the superomedial genicular nerve, superolateral genicular nerve, inferomedial genicular nerve, and nerve to vastus intermedius.
Genicular Nerve Block with bupivacaine and preservative free dexamethasone: A genicular nerve block is a peripheral nerve block that temporarily anesthetizes the sensory terminal branches innervating the knee joint by injecting local anesthesia. This results in anesthesia of the anterior compartment of the knee.
The genicular nerve block consists of 20cc of 0.25% bupivacaine with 2mg of preservative free dexamethasone and will be applied to the superomedial genicular nerve, superolateral genicular nerve, inferomedial genicular nerve, and nerve to vastus intermedius.
Bupivacaine - Drug class: Sodium channel blocker
Dexamethasone - Drug class: Glucocorticoid
|
|---|---|---|
|
Cumulative Opioid Consumption
0-24 hours
|
22.5 morphine milligram equivalents
Interval 0.0 to 67.5
|
15 morphine milligram equivalents
Interval 0.0 to 97.5
|
|
Cumulative Opioid Consumption
0-48 hours
|
33.75 morphine milligram equivalents
Interval 0.0 to 105.0
|
30 morphine milligram equivalents
Interval 0.0 to 142.5
|
|
Cumulative Opioid Consumption
0-72 hours
|
37.5 morphine milligram equivalents
Interval 0.0 to 142.5
|
37.5 morphine milligram equivalents
Interval 0.0 to 165.0
|
|
Cumulative Opioid Consumption
0-96 hours
|
41.3 morphine milligram equivalents
Interval 0.0 to 168.75
|
45 morphine milligram equivalents
Interval 0.0 to 225.0
|
SECONDARY outcome
Timeframe: Pre-operatively, 24 hours, 48 hours, 72 hours, 96 hours, 168 hours post-operativePopulation: At each time point, patients were lost to follow up.
This questionnaire will assess severity of pain, impact of pain on daily function, location of pain, medication intake, and amount of pain relief preoperatively and at 24 hours, 48 hours, 72 hours, 96 hours, and 168 hours after surgery. Questions are rated on a scale of 0 to 10, with 0 meaning "no pain/interference" and 10 meaning "pain as bad as you can imagine/completely interferes".
Outcome measures
| Measure |
Group 1 - Control
n=96 Participants
Patients randomized to this group will receive an adductor canal block (ACB) and Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) nerve block.
|
Group 2 - Intervention
n=95 Participants
Patients randomized to this group will receive an adductor canal block (ACB), Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) nerve block, and the genicular nerve block (intervention).
The genicular nerve block is a total of 20cc of 0.25% bupivacaine with 2mg of preservative free dexamethasone applied to the superomedial genicular nerve, superolateral genicular nerve, inferomedial genicular nerve, and nerve to vastus intermedius.
Genicular Nerve Block with bupivacaine and preservative free dexamethasone: A genicular nerve block is a peripheral nerve block that temporarily anesthetizes the sensory terminal branches innervating the knee joint by injecting local anesthesia. This results in anesthesia of the anterior compartment of the knee.
The genicular nerve block consists of 20cc of 0.25% bupivacaine with 2mg of preservative free dexamethasone and will be applied to the superomedial genicular nerve, superolateral genicular nerve, inferomedial genicular nerve, and nerve to vastus intermedius.
Bupivacaine - Drug class: Sodium channel blocker
Dexamethasone - Drug class: Glucocorticoid
|
|---|---|---|
|
Brief Pain Inventory
48 hours least pain
|
2 score on a scale
Interval 0.0 to 10.0
|
2 score on a scale
Interval 0.0 to 6.0
|
|
Brief Pain Inventory
Preoperative Worst Pain
|
2 score on a scale
Interval 0.0 to 10.0
|
2 score on a scale
Interval 0.0 to 9.0
|
|
Brief Pain Inventory
Preoperative Least Pain
|
0 score on a scale
Interval 0.0 to 7.0
|
0 score on a scale
Interval 0.0 to 6.0
|
|
Brief Pain Inventory
Preoperative Average Pain
|
1 score on a scale
Interval 0.0 to 8.0
|
1 score on a scale
Interval 0.0 to 6.0
|
|
Brief Pain Inventory
Preoperative Current Pain
|
0 score on a scale
Interval 0.0 to 8.0
|
0 score on a scale
Interval 0.0 to 5.0
|
|
Brief Pain Inventory
Preoperative Interference
|
1.14 score on a scale
Interval 0.0 to 6.86
|
1.14 score on a scale
Interval 0.0 to 8.43
|
|
Brief Pain Inventory
24 hours worst pain
|
7 score on a scale
Interval 2.0 to 10.0
|
7 score on a scale
Interval 0.0 to 10.0
|
|
Brief Pain Inventory
24 hours least pain
|
2 score on a scale
Interval 0.0 to 9.0
|
2 score on a scale
Interval 0.0 to 7.0
|
|
Brief Pain Inventory
24 hours average pain
|
4 score on a scale
Interval 0.0 to 10.0
|
3 score on a scale
Interval 0.0 to 9.0
|
|
Brief Pain Inventory
24 hours current pain
|
3 score on a scale
Interval 0.0 to 10.0
|
3 score on a scale
Interval 0.0 to 9.0
|
|
Brief Pain Inventory
24 hours interference
|
3.57 score on a scale
Interval 0.0 to 8.57
|
3.07 score on a scale
Interval 0.0 to 8.0
|
|
Brief Pain Inventory
48 hours worst pain
|
7 score on a scale
Interval 0.0 to 10.0
|
6 score on a scale
Interval 2.0 to 10.0
|
|
Brief Pain Inventory
48 hours average pain
|
4 score on a scale
Interval 0.0 to 10.0
|
4 score on a scale
Interval 0.0 to 8.0
|
|
Brief Pain Inventory
48 hours current pain
|
3 score on a scale
Interval 0.0 to 10.0
|
3 score on a scale
Interval 0.0 to 8.0
|
|
Brief Pain Inventory
48 hours interference
|
4.14 score on a scale
Interval 0.0 to 8.71
|
3.86 score on a scale
Interval 0.0 to 8.43
|
|
Brief Pain Inventory
72 hours worst pain
|
6 score on a scale
Interval 0.0 to 10.0
|
6 score on a scale
Interval 1.0 to 10.0
|
|
Brief Pain Inventory
72 hours least pain
|
2 score on a scale
Interval 0.0 to 8.0
|
1 score on a scale
Interval 0.0 to 6.0
|
|
Brief Pain Inventory
72 hours average pain
|
3 score on a scale
Interval 0.0 to 8.0
|
3 score on a scale
Interval 0.0 to 7.0
|
|
Brief Pain Inventory
72 hours current pain
|
3 score on a scale
Interval 0.0 to 9.0
|
2 score on a scale
Interval 0.0 to 7.0
|
|
Brief Pain Inventory
72 hours interference
|
6 score on a scale
Interval 0.0 to 10.0
|
5 score on a scale
Interval 0.0 to 10.0
|
|
Brief Pain Inventory
96 hours worst pain
|
5 score on a scale
Interval 0.0 to 10.0
|
5 score on a scale
Interval 1.0 to 9.0
|
|
Brief Pain Inventory
96 hours least pain
|
1 score on a scale
Interval 0.0 to 8.0
|
1 score on a scale
Interval 0.0 to 6.0
|
|
Brief Pain Inventory
96 hours average pain
|
2 score on a scale
Interval 0.0 to 9.0
|
3 score on a scale
Interval 0.0 to 8.0
|
|
Brief Pain Inventory
96 hours current pain
|
2 score on a scale
Interval 0.0 to 9.0
|
2 score on a scale
Interval 0.0 to 7.0
|
|
Brief Pain Inventory
96 hours interference
|
3.14 score on a scale
Interval 0.0 to 8.0
|
2.86 score on a scale
Interval 0.0 to 8.57
|
|
Brief Pain Inventory
168 hours worst pain
|
4 score on a scale
Interval 1.0 to 10.0
|
4 score on a scale
Interval 1.0 to 9.0
|
|
Brief Pain Inventory
168 hours least pain
|
0 score on a scale
Interval 0.0 to 8.0
|
0 score on a scale
Interval 0.0 to 6.0
|
|
Brief Pain Inventory
168 hours average pain
|
2 score on a scale
Interval 0.0 to 9.0
|
2 score on a scale
Interval 0.0 to 8.0
|
|
Brief Pain Inventory
168 hours current pain
|
1 score on a scale
Interval 0.0 to 9.0
|
1 score on a scale
Interval 0.0 to 7.0
|
|
Brief Pain Inventory
168 hours interference
|
2.14 score on a scale
Interval 0.0 to 6.14
|
2 score on a scale
Interval 0.0 to 8.29
|
SECONDARY outcome
Timeframe: From the time patient arrived in the post-operative care unit (PACU), at 24 hours, and at 48 hours post-operativePopulation: At each time point, patients were lost to follow up.
Patient satisfaction will be assessed in the post-operative care unit (PACU), 24 hours, and 48 hours after surgery. Patients reported satisfaction for 3 subcategories: 1) Satisfaction with Pain Management, 2) Satisfaction with Being Informed and Involved with Decision Making, 3) Satisfaction with Care from Healthcare Team. Each subcategory had a scale of 0-10, with 0 being strongly dissatisfied and 10 being strongly satisfied.
Outcome measures
| Measure |
Group 1 - Control
n=96 Participants
Patients randomized to this group will receive an adductor canal block (ACB) and Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) nerve block.
|
Group 2 - Intervention
n=95 Participants
Patients randomized to this group will receive an adductor canal block (ACB), Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) nerve block, and the genicular nerve block (intervention).
The genicular nerve block is a total of 20cc of 0.25% bupivacaine with 2mg of preservative free dexamethasone applied to the superomedial genicular nerve, superolateral genicular nerve, inferomedial genicular nerve, and nerve to vastus intermedius.
Genicular Nerve Block with bupivacaine and preservative free dexamethasone: A genicular nerve block is a peripheral nerve block that temporarily anesthetizes the sensory terminal branches innervating the knee joint by injecting local anesthesia. This results in anesthesia of the anterior compartment of the knee.
The genicular nerve block consists of 20cc of 0.25% bupivacaine with 2mg of preservative free dexamethasone and will be applied to the superomedial genicular nerve, superolateral genicular nerve, inferomedial genicular nerve, and nerve to vastus intermedius.
Bupivacaine - Drug class: Sodium channel blocker
Dexamethasone - Drug class: Glucocorticoid
|
|---|---|---|
|
Patient Satisfaction With Pain Treatment
PACU Satisfaction with Pain Management
|
10 score on a scale
Interval 0.0 to 10.0
|
10 score on a scale
Interval 5.0 to 10.0
|
|
Patient Satisfaction With Pain Treatment
PACU Satisfaction with Being Informed and Involved with Decision Making
|
10 score on a scale
Interval 6.0 to 10.0
|
10 score on a scale
Interval 4.0 to 10.0
|
|
Patient Satisfaction With Pain Treatment
PACU Satisfaction with Care from Healthcare Team
|
10 score on a scale
Interval 7.0 to 10.0
|
10 score on a scale
Interval 8.0 to 10.0
|
|
Patient Satisfaction With Pain Treatment
24 Hours Satisfaction with Pain Management
|
9 score on a scale
Interval 0.0 to 10.0
|
9.5 score on a scale
Interval 5.0 to 10.0
|
|
Patient Satisfaction With Pain Treatment
24 hours Satisfaction with Being Informed and Involved with Decision Making
|
10 score on a scale
Interval 6.0 to 10.0
|
10 score on a scale
Interval 4.0 to 10.0
|
|
Patient Satisfaction With Pain Treatment
24 hours Satisfaction with Care from Healthcare Team
|
10 score on a scale
Interval 5.0 to 10.0
|
10 score on a scale
Interval 6.0 to 10.0
|
|
Patient Satisfaction With Pain Treatment
48 Hours Satisfaction with Pain Management
|
9 score on a scale
Interval 0.0 to 10.0
|
10 score on a scale
Interval 5.0 to 10.0
|
|
Patient Satisfaction With Pain Treatment
48 hours Satisfaction with Being Informed and Involved with Decision Making
|
10 score on a scale
Interval 6.0 to 10.0
|
10 score on a scale
Interval 4.0 to 10.0
|
|
Patient Satisfaction With Pain Treatment
48 hours Satisfaction with Care from Healthcare Team
|
10 score on a scale
Interval 6.0 to 10.0
|
10 score on a scale
Interval 6.0 to 10.0
|
SECONDARY outcome
Timeframe: 24 hours and 48 hours post-operativePopulation: At each time point, some patients were lost to follow up and some patients did not have feeling return yet.
To assess when the patient believe the analgesic block wore off and they regain sensation in their leg.
Outcome measures
| Measure |
Group 1 - Control
n=96 Participants
Patients randomized to this group will receive an adductor canal block (ACB) and Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) nerve block.
|
Group 2 - Intervention
n=95 Participants
Patients randomized to this group will receive an adductor canal block (ACB), Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) nerve block, and the genicular nerve block (intervention).
The genicular nerve block is a total of 20cc of 0.25% bupivacaine with 2mg of preservative free dexamethasone applied to the superomedial genicular nerve, superolateral genicular nerve, inferomedial genicular nerve, and nerve to vastus intermedius.
Genicular Nerve Block with bupivacaine and preservative free dexamethasone: A genicular nerve block is a peripheral nerve block that temporarily anesthetizes the sensory terminal branches innervating the knee joint by injecting local anesthesia. This results in anesthesia of the anterior compartment of the knee.
The genicular nerve block consists of 20cc of 0.25% bupivacaine with 2mg of preservative free dexamethasone and will be applied to the superomedial genicular nerve, superolateral genicular nerve, inferomedial genicular nerve, and nerve to vastus intermedius.
Bupivacaine - Drug class: Sodium channel blocker
Dexamethasone - Drug class: Glucocorticoid
|
|---|---|---|
|
Duration of Analgesic Block
24 hours
|
15.8 hours
Interval 5.03 to 22.65
|
13.825 hours
Interval 8.22 to 21.97
|
|
Duration of Analgesic Block
48 hours
|
22.19 hours
Interval 10.92 to 35.77
|
25.05 hours
Interval 11.83 to 38.15
|
SECONDARY outcome
Timeframe: Post-operative care unit (PACU)Population: One patient was withdrawn from the intervention group. For one patient in the control group, data was not able to be obtained for success of adductor canal block.
Numbness in the saphenous distribution will be assessed in the PACU by an anesthesiologist or research assistant. This was measured on scale of 0-2, with 0 being no sensation, 1 being partial sensation, and 2 being full sensation.
Outcome measures
| Measure |
Group 1 - Control
n=95 Participants
Patients randomized to this group will receive an adductor canal block (ACB) and Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) nerve block.
|
Group 2 - Intervention
n=95 Participants
Patients randomized to this group will receive an adductor canal block (ACB), Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) nerve block, and the genicular nerve block (intervention).
The genicular nerve block is a total of 20cc of 0.25% bupivacaine with 2mg of preservative free dexamethasone applied to the superomedial genicular nerve, superolateral genicular nerve, inferomedial genicular nerve, and nerve to vastus intermedius.
Genicular Nerve Block with bupivacaine and preservative free dexamethasone: A genicular nerve block is a peripheral nerve block that temporarily anesthetizes the sensory terminal branches innervating the knee joint by injecting local anesthesia. This results in anesthesia of the anterior compartment of the knee.
The genicular nerve block consists of 20cc of 0.25% bupivacaine with 2mg of preservative free dexamethasone and will be applied to the superomedial genicular nerve, superolateral genicular nerve, inferomedial genicular nerve, and nerve to vastus intermedius.
Bupivacaine - Drug class: Sodium channel blocker
Dexamethasone - Drug class: Glucocorticoid
|
|---|---|---|
|
Success of Adductor Canal Block
Medial Calf · Partial sensation
|
45 Participants
|
32 Participants
|
|
Success of Adductor Canal Block
Medial Calf · Full sensation
|
22 Participants
|
8 Participants
|
|
Success of Adductor Canal Block
Lateral Calf · No sensation
|
9 Participants
|
16 Participants
|
|
Success of Adductor Canal Block
Lateral Calf · Partial sensation
|
41 Participants
|
61 Participants
|
|
Success of Adductor Canal Block
Lateral Calf · Full sensation
|
45 Participants
|
18 Participants
|
|
Success of Adductor Canal Block
Dorsal Calf · No sensation
|
11 Participants
|
7 Participants
|
|
Success of Adductor Canal Block
Dorsal Calf · Partial sensation
|
27 Participants
|
58 Participants
|
|
Success of Adductor Canal Block
Dorsal Calf · Full sensation
|
57 Participants
|
30 Participants
|
|
Success of Adductor Canal Block
Plantar Aspect · No sensation
|
1 Participants
|
3 Participants
|
|
Success of Adductor Canal Block
Plantar Aspect · Partial sensation
|
37 Participants
|
53 Participants
|
|
Success of Adductor Canal Block
Plantar Aspect · Full sensation
|
57 Participants
|
39 Participants
|
|
Success of Adductor Canal Block
Medial Calf · No sensation
|
28 Participants
|
55 Participants
|
SECONDARY outcome
Timeframe: From the time the patient arrived in the post-operative care unit (PACU) arrival time to the time the patient is discharged(discharge ready time = recovery complete time) assessed up to 24 hours after surgery.Population: One patient was withdrawn from the intervention group.
The duration from PACU arrival time to recovery complete time. The time that it took for the patient to be discharged will be calculated and reported.
Outcome measures
| Measure |
Group 1 - Control
n=96 Participants
Patients randomized to this group will receive an adductor canal block (ACB) and Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) nerve block.
|
Group 2 - Intervention
n=95 Participants
Patients randomized to this group will receive an adductor canal block (ACB), Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) nerve block, and the genicular nerve block (intervention).
The genicular nerve block is a total of 20cc of 0.25% bupivacaine with 2mg of preservative free dexamethasone applied to the superomedial genicular nerve, superolateral genicular nerve, inferomedial genicular nerve, and nerve to vastus intermedius.
Genicular Nerve Block with bupivacaine and preservative free dexamethasone: A genicular nerve block is a peripheral nerve block that temporarily anesthetizes the sensory terminal branches innervating the knee joint by injecting local anesthesia. This results in anesthesia of the anterior compartment of the knee.
The genicular nerve block consists of 20cc of 0.25% bupivacaine with 2mg of preservative free dexamethasone and will be applied to the superomedial genicular nerve, superolateral genicular nerve, inferomedial genicular nerve, and nerve to vastus intermedius.
Bupivacaine - Drug class: Sodium channel blocker
Dexamethasone - Drug class: Glucocorticoid
|
|---|---|---|
|
Readiness for PACU Discharge
|
1.69 hours
Interval 0.1 to 3.3
|
1.67 hours
Interval 0.75 to 2.93
|
SECONDARY outcome
Timeframe: From the time the patient arrived in the post-operative care unit (PACU) arrival time to the time they leave the PACU assessed up to 24 hours after surgery.Population: One patient was withdrawn from the intervention group.
The duration from PACU arrival time to patient removed from board time. The time (in minutes) will be calculated and reported.
Outcome measures
| Measure |
Group 1 - Control
n=96 Participants
Patients randomized to this group will receive an adductor canal block (ACB) and Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) nerve block.
|
Group 2 - Intervention
n=95 Participants
Patients randomized to this group will receive an adductor canal block (ACB), Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) nerve block, and the genicular nerve block (intervention).
The genicular nerve block is a total of 20cc of 0.25% bupivacaine with 2mg of preservative free dexamethasone applied to the superomedial genicular nerve, superolateral genicular nerve, inferomedial genicular nerve, and nerve to vastus intermedius.
Genicular Nerve Block with bupivacaine and preservative free dexamethasone: A genicular nerve block is a peripheral nerve block that temporarily anesthetizes the sensory terminal branches innervating the knee joint by injecting local anesthesia. This results in anesthesia of the anterior compartment of the knee.
The genicular nerve block consists of 20cc of 0.25% bupivacaine with 2mg of preservative free dexamethasone and will be applied to the superomedial genicular nerve, superolateral genicular nerve, inferomedial genicular nerve, and nerve to vastus intermedius.
Bupivacaine - Drug class: Sodium channel blocker
Dexamethasone - Drug class: Glucocorticoid
|
|---|---|---|
|
Length of PACU Stay
|
125.5 minutes
Interval 111.5 to 147.0
|
124.0 minutes
Interval 109.0 to 146.0
|
SECONDARY outcome
Timeframe: Post-operative care unit (PACU) arrival time up to 72 hours after the surgeryPopulation: One patient was withdrawn from the intervention group.
Incidence of neuropraxia (neurological symptoms over 3 days), local anesthetic systemic toxicity (LAST), and infection. The number of adverse events will be reported.
Outcome measures
| Measure |
Group 1 - Control
n=96 Participants
Patients randomized to this group will receive an adductor canal block (ACB) and Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) nerve block.
|
Group 2 - Intervention
n=95 Participants
Patients randomized to this group will receive an adductor canal block (ACB), Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) nerve block, and the genicular nerve block (intervention).
The genicular nerve block is a total of 20cc of 0.25% bupivacaine with 2mg of preservative free dexamethasone applied to the superomedial genicular nerve, superolateral genicular nerve, inferomedial genicular nerve, and nerve to vastus intermedius.
Genicular Nerve Block with bupivacaine and preservative free dexamethasone: A genicular nerve block is a peripheral nerve block that temporarily anesthetizes the sensory terminal branches innervating the knee joint by injecting local anesthesia. This results in anesthesia of the anterior compartment of the knee.
The genicular nerve block consists of 20cc of 0.25% bupivacaine with 2mg of preservative free dexamethasone and will be applied to the superomedial genicular nerve, superolateral genicular nerve, inferomedial genicular nerve, and nerve to vastus intermedius.
Bupivacaine - Drug class: Sodium channel blocker
Dexamethasone - Drug class: Glucocorticoid
|
|---|---|---|
|
Adverse Events
|
0 Participants
|
0 Participants
|
Adverse Events
Group 1 - Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2 - Intervention
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