Trial Outcomes & Findings for Analgesic Benefits of Genicular Nerve Blocks of the Posterior Knee for Patients Undergoing ACL Reconstruction (NCT NCT02008617)
NCT ID: NCT02008617
Last Updated: 2017-04-19
Results Overview
Opioid consumption (mg morphine equivalents)
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
18 participants
Primary outcome timeframe
24 hours
Results posted on
2017-04-19
Participant Flow
Participant milestones
| Measure |
Study Drug
Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000
Bupivacaine: 30mL of Bupivicaine 0.20% with epinephrine 1:300,000
|
Preservative Free Normal Saline
Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline
Preservative free normal saline: Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
10
|
|
Overall Study
COMPLETED
|
8
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Analgesic Benefits of Genicular Nerve Blocks of the Posterior Knee for Patients Undergoing ACL Reconstruction
Baseline characteristics by cohort
| Measure |
Study Drug
n=8 Participants
Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000
Bupivacaine: 30mL of Bupivicaine 0.20% with epinephrine 1:300,000
|
Preservative Free Normal Saline
n=10 Participants
Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline
Preservative free normal saline: Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25 years
n=5 Participants
|
29 years
n=7 Participants
|
27 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursOpioid consumption (mg morphine equivalents)
Outcome measures
| Measure |
Study Drug
n=8 Participants
Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000
Bupivacaine: 30mL of Bupivicaine 0.20% with epinephrine 1:300,000
|
Preservative Free Normal Saline
n=10 Participants
Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline
Preservative free normal saline: Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline
|
|---|---|---|
|
Opioid Consumption
|
50 mg morphine equivalents
Interval 40.0 to 70.0
|
70 mg morphine equivalents
Interval 50.0 to 80.0
|
SECONDARY outcome
Timeframe: Pain Burden at 24hrsNumeric Rating Scale (NRS) (NRS pain scores; 0 = no pain,10 = excruciating pain) in the back of the knee recorded every 4 hours up to 24hrs following surgery. Pain Bruden scale ranges from 0 (no pain) to 240 (extreme pain). For example, pain burden of 120 is equivalent to a NRS score of 5 out of 10.
Outcome measures
| Measure |
Study Drug
n=8 Participants
Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000
Bupivacaine: 30mL of Bupivicaine 0.20% with epinephrine 1:300,000
|
Preservative Free Normal Saline
n=10 Participants
Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline
Preservative free normal saline: Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline
|
|---|---|---|
|
Pain Score
Pain Score during plantar flexion
|
115 units on a scale
Interval 50.0 to 182.0
|
128 units on a scale
Interval 96.0 to 144.0
|
|
Pain Score
Pain Score at Rest
|
102 units on a scale
Interval 58.0 to 160.0
|
135 units on a scale
Interval 112.0 to 146.0
|
SECONDARY outcome
Timeframe: 24hrPatient satisfaction with pain control scale ranges from 0 (no satisfaction) to 10 (very satisfied).
Outcome measures
| Measure |
Study Drug
n=8 Participants
Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000
Bupivacaine: 30mL of Bupivicaine 0.20% with epinephrine 1:300,000
|
Preservative Free Normal Saline
n=10 Participants
Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline
Preservative free normal saline: Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline
|
|---|---|---|
|
Patient Satisfaction
|
8 units on a scale
Interval 7.0 to 8.0
|
8 units on a scale
Interval 6.0 to 10.0
|
SECONDARY outcome
Timeframe: 24hrsQuality of recovery (QoR15) is a questionnaire that asks 15 questions regarding how the participant has felt in the last 24 hours. Each question is followed by an 11-point numerical rating scale (0 = "none of the time" to 10 = "all of the time"; maximum score 150). The higher the QoR15 total score, the worse the quality of recovery reported.
Outcome measures
| Measure |
Study Drug
n=8 Participants
Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000
Bupivacaine: 30mL of Bupivicaine 0.20% with epinephrine 1:300,000
|
Preservative Free Normal Saline
n=10 Participants
Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline
Preservative free normal saline: Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline
|
|---|---|---|
|
Quality of Recovery (QoR15)
|
96 units on a scale
Interval 84.0 to 110.0
|
102 units on a scale
Interval 80.0 to 114.0
|
Adverse Events
Study Drug
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Preservative Free Normal Saline
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
Rohit Rahangdale, M.D.
Northwestern University, Feinberg School of Medicine
Phone: 312-695-4814
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place