Internal Derangement of Knee
Conditions
Keywords
infrapatellar nerve, saphenous nerve, knee arthroscopy, nerve block
Brief summary
The purpose of this study is to determine whether infrapatellar branch of the saphenous nerve blocks are effective in decreasing analgesic use, promoting earlier mobility, and improving long term outcome scores after knee arthroscopy.
Detailed description
The purpose of this study is to determine whether infrapatellar branch of the saphenous nerve blocks are effective in decreasing analgesic use, promoting earlier mobility, and improving long term outcome scores after knee arthroscopy. Randomized, double-blinded, placebo controlled, study.
Interventions
10cc, single dose, US guided injection
DRUGNormal Saline
10cc, single dose, US guided injection
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* planned knee arthroscopy with soft tissue intervention * age 18+ * English speaking
Exclusion criteria
* contraindications to nerve block: eg neuropathy, type 1 diabetes, coagulopathy * knee arthroscopy with planned bony intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post op Pain Score | 0 hours | immediate postop pain score, Visual Analog Scale. Evaluates pain on scale from 0-10. 0=no pain. 10=maximum pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo A sham infrapatellar block performed under US guidance with normal saline
Normal Saline: 10cc, single dose, US guided injection | 34 |
| Infrapatellar Nerve Block An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine
0.25% Bupivacaine: 10cc, single dose, US guided injection | 34 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 1 |
Baseline characteristics
| Characteristic | Placebo | Infrapatellar Nerve Block | Total |
|---|---|---|---|
| Age, Continuous | 49.6 years STANDARD_DEVIATION 14.1 | 51.7 years STANDARD_DEVIATION 12.1 | 50.6 years STANDARD_DEVIATION 13 |
| Sex: Female, Male Female | 16 Participants | 19 Participants | 35 Participants |
| Sex: Female, Male Male | 18 Participants | 15 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 34 | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 | 0 / 34 |
Outcome results
Primary
Post op Pain Score
immediate postop pain score, Visual Analog Scale. Evaluates pain on scale from 0-10. 0=no pain. 10=maximum pain.
Time frame: 0 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Post op Pain Score | 5.5 units on a scale | Standard Deviation 2.6 |
| Infrapatellar Nerve Block | Post op Pain Score | 3.9 units on a scale | Standard Deviation 3.3 |