Trial Outcomes & Findings for IPACK Versus Popliteal Sciatic Nerve Block in ACL Reconstruction (NCT NCT03983941)
NCT ID: NCT03983941
Last Updated: 2021-09-16
Results Overview
Visual Analogue Scale (VAS) pain scores (0 being no pain and 10 being worst pain) from arrival to post-anesthesia care unit (PACU) to 48 hours after discharge from surgery center.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
7 participants
Primary outcome timeframe
Immediately post-operatively and up to 48 hours post-discharge, an average of 48 hours
Results posted on
2021-09-16
Participant Flow
Participant milestones
| Measure |
FNB-AC + Sciatic Nerve Block
Patients will receive up to 20 mL of 0.2% ropivacaine for FNB-AC and up to 20 mL of 0.2% ropivacaine for sciatic nerve block under ultrasound guidance.
Ropivacaine injection: Total dose not to exceed 3 mg/kg of ropivacaine.
|
FNB-AC + IPACK
Patients will receive up to 20 mL of 0.2% ropivacaine for FNB-AC and up to 20 mL of 0.2% ropivacaine for posterior knee capsular infiltration under ultrasound guidance (IPACK)
Ropivacaine injection: Total dose not to exceed 3 mg/kg of ropivacaine.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
5
|
|
Overall Study
COMPLETED
|
2
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
IPACK Versus Popliteal Sciatic Nerve Block in ACL Reconstruction
Baseline characteristics by cohort
| Measure |
FNB-AC + Sciatic Nerve Block
n=2 Participants
Patients will receive up to 20 mL of 0.2% ropivacaine for FNB-AC and up to 20 mL of 0.2% ropivacaine for sciatic nerve block under ultrasound guidance.
Ropivacaine injection: Total dose not to exceed 3 mg/kg of ropivacaine.
|
FNB-AC + IPACK
n=5 Participants
Patients will receive up to 20 mL of 0.2% ropivacaine for FNB-AC and up to 20 mL of 0.2% ropivacaine for posterior knee capsular infiltration under ultrasound guidance (IPACK)
Ropivacaine injection: Total dose not to exceed 3 mg/kg of ropivacaine.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
15.8 years
n=93 Participants
|
17 years
n=4 Participants
|
16.7 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Immediately post-operatively and up to 48 hours post-discharge, an average of 48 hoursVisual Analogue Scale (VAS) pain scores (0 being no pain and 10 being worst pain) from arrival to post-anesthesia care unit (PACU) to 48 hours after discharge from surgery center.
Outcome measures
| Measure |
FNB-AC + Sciatic Nerve Block
n=2 Participants
Patients will receive up to 20 mL of 0.2% ropivacaine for FNB-AC and up to 20 mL of 0.2% ropivacaine for sciatic nerve block under ultrasound guidance.
Ropivacaine injection: Total dose not to exceed 3 mg/kg of ropivacaine.
|
FNB-AC + IPACK
n=5 Participants
Patients will receive up to 20 mL of 0.2% ropivacaine for FNB-AC and up to 20 mL of 0.2% ropivacaine for posterior knee capsular infiltration under ultrasound guidance (IPACK)
Ropivacaine injection: Total dose not to exceed 3 mg/kg of ropivacaine.
|
|---|---|---|
|
Average Post-operative Pain Score
|
4.7 score on a scale
Standard Deviation 3.368
|
4 score on a scale
Standard Deviation 2.905
|
SECONDARY outcome
Timeframe: Intra-operative and up to 48 hours post-discharge, an average of 48 hoursNumber of doses of narcotic pain medicine administered during surgery and up to 48 hours after discharge from surgery center.
Outcome measures
| Measure |
FNB-AC + Sciatic Nerve Block
n=2 Participants
Patients will receive up to 20 mL of 0.2% ropivacaine for FNB-AC and up to 20 mL of 0.2% ropivacaine for sciatic nerve block under ultrasound guidance.
Ropivacaine injection: Total dose not to exceed 3 mg/kg of ropivacaine.
|
FNB-AC + IPACK
n=5 Participants
Patients will receive up to 20 mL of 0.2% ropivacaine for FNB-AC and up to 20 mL of 0.2% ropivacaine for posterior knee capsular infiltration under ultrasound guidance (IPACK)
Ropivacaine injection: Total dose not to exceed 3 mg/kg of ropivacaine.
|
|---|---|---|
|
Number of Opioid Doses Administered
|
5.5 opiod doses administered
Interval 4.0 to 7.0
|
3.8 opiod doses administered
Interval 2.0 to 5.0
|
Adverse Events
FNB-AC + Sciatic Nerve Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
FNB-AC + IPACK
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