Anterior Cruciate Ligament Tear
Conditions
Brief summary
This is a prospective study comparing femoral nerve block plus sciatic nerve block to femoral nerve block plus infiltration of the posterior knee capsule (IPACK) in patients undergoing arthroscopic anterior cruciate ligament reconstruction. Femoral nerve block via the adductor canal (FNB-AC) with IPACK may provide effective analgesia while avoiding the motor block involved with sciatic nerve block. The lack of motor block is important to facilitate postoperative ambulation and physical therapy.
Interventions
DRUGRopivacaine injection
Total dose not to exceed 3 mg/kg of ropivacaine.
Sponsors
Sujana Dontukurthy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No
Inclusion criteria
* Patients less than 21 years of age * American Society of Anesthesiologists physical status I and II * Undergoing elective anterior cruciate ligament reconstruction
Exclusion criteria
* They are unable or unwilling to take part in the study * History of allergy to any of the medications administered for the nerve block * Contraindication to peripheral nerve block * Patients who are unable to understand instructions or questions related to the study or the families required language interpretation * Patients who consume opioid medications for more than three days per week for more than a month prior to surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Post-operative Pain Score | Immediately post-operatively and up to 48 hours post-discharge, an average of 48 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Opioid Doses Administered | Intra-operative and up to 48 hours post-discharge, an average of 48 hours | Number of doses of narcotic pain medicine administered during surgery and up to 48 hours after discharge from surgery center. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2 |
| 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. | 5 |
| Total | 7 |
Baseline characteristics
| Characteristic | FNB-AC + Sciatic Nerve Block | FNB-AC + IPACK | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 3 Participants | 5 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 2 Participants | 2 Participants |
| Age, Continuous | 15.8 years | 17 years | 16.7 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 5 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 4 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 5 |
| other Total, other adverse events | 0 / 2 | 0 / 5 |
| serious Total, serious adverse events | 0 / 2 | 0 / 5 |
Outcome results
Primary
Average Post-operative Pain Score
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.
Time frame: Immediately post-operatively and up to 48 hours post-discharge, an average of 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FNB-AC + Sciatic Nerve Block | Average Post-operative Pain Score | 4.7 score on a scale | Standard Deviation 3.368 |
| FNB-AC + IPACK | Average Post-operative Pain Score | 4 score on a scale | Standard Deviation 2.905 |
Secondary
Number of Opioid Doses Administered
Number of doses of narcotic pain medicine administered during surgery and up to 48 hours after discharge from surgery center.
Time frame: Intra-operative and up to 48 hours post-discharge, an average of 48 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FNB-AC + Sciatic Nerve Block | Number of Opioid Doses Administered | 5.5 opiod doses administered |
| FNB-AC + IPACK | Number of Opioid Doses Administered | 3.8 opiod doses administered |