Anterior Cruciate Ligament Tear, Knee Meniscus Tear
Conditions
Keywords
Knee arthroscopy, ACL reconstruction, Femoral block, Adductor Canal Block
Brief summary
The purpose of this study is to compare the effects of a femoral nerve block vs. an adductor canal block on pain and quadriceps muscle strength for knee arthroscopy surgery.
Detailed description
Patients undergoing arthroscopic knee surgery (ACL and non-ACL surgery) typically receive an ultrasound-guided femoral nerve block or an adductor canal block in the pre-operative phase for post-operative pain control. While an effective method for post-operative analgesia, the femoral nerve block is associated with profound quadriceps weakness for the duration of the nerve block, which can impair ambulation, rehabilitation, and increase the risk of falls. The more distal adductor canal block, however, contains primarily sensory branches of the femoral nerve and has been been purported by small volunteer studies to provide equally effective analgesia with minimal motor block and quadriceps weakness (as compared to femoral nerve block). The investigators will prospectively randomize patients undergoing knee arthroscopy at the UCSF Orthopaedic Institute to receive either a single-shot femoral nerve or adductor canal block pre-operatively after taking baseline measurements of quadriceps strength (quantified by maximum voluntary isometric contraction). The quadriceps muscle strength will be checked 20 minutes after the nerve block to assess strength. All patients will subsequently undergo a general anesthetic. The primary outcome variable will be post-block quadriceps strength as a percentage of baseline from pre-block values. Secondary outcome variables that will also investigated include: VAS pain score in the post anesthesia recovery unit and post-operative day 1, duration of nerve blockade, and perioperative opioid consumption.
Interventions
PROCEDUREFemoral Nerve Block
Patients having ACL reconstruction, meniscus surgery and knee arthroscopy
PROCEDUREAdductor Canal Nerve Block
Patients having ACL reconstruction, meniscus surgery and knee arthroscopy
DRUGpreoperative Femoral Nerve Block using 20ml of 0.5% ropivacaine
DRUGPreoperative Adductor canal block with 0.75%% ropivacaine 13.3ml.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesia I-III classification, * Scheduled for arthroscopic knee surgery (meniscal debridement/repair, ACL reconstruction)
Exclusion criteria
* Age younger than 18 years * Non-English speaking * Any contraindication for regional anesthesia, such as allergy to local anesthetics or opioids, -Coagulopaty or severe thrombocytopenia * Infection at puncture sites * Pre-existing neuropathy in operative limb * Need for post-operative nerve function monitoring * Dementia * Patient refusal * High pre-operative opioid requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quadriceps Strength Related to the Nerve Block | Baseline and 20 minutes after the block prior to surgery | Quadriceps strength will be tested with a dynamometer before the nerve block and 20 minutes after the nerve block prior to surgery. The dynamometer measures the strength of the quadriceps muscles in the seated position while pushing against the device. We are trying to measure the effect of both femoral and adductor canal nerve blocks on quadriceps strength. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Pain Score From 0-10 | worse pain in first 24 hours | As this is an outpatient surgery, we will collect Numerical Pain Scores from the recovery room medical record after surgery as well as from the patients for the first 24 hours after surgery by contacting them at home the following day. We will evaluate the difference in patient pain scores between the two nerve blocks under study. The highest pain score for the 24-hour post-op period was collected for each participant. The median is reported for all participants. A pain score of 10 represents the worst pain. |
| Duration of Nerve Block | 8 to 24 hours | Patients will be contacted after surgery to determine when the nerve block wore off based on their increase in pain |
| Opioid Consumption Reported at mg of Morphine Equivalence | 2 days | Data on the amount of pain medication consumed for the 1st 24 hours after surgery will be collected based on medications that were administered during surgery, in the recovery room and medications that patients took at home after discharge from the recovery room. All pain medications will be converted to morphine equivalence in milligrams and reported that way. The comparison will be the difference in mg morphine equivalence consumption between the two nerve block groups. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Femoral Block for Knee Arthroscopy/Meniscus Surgery Patients scheduled for knee arthroscopy will have a femoral nerve block done using 0.5% ropivacaine 20ml before surgery. | 26 |
| Adductor Canal Block for Knee Arthroscopy/Meniscus Surgery Patients scheduled for knee arthroscopy will have an adductor canal block done using 0.75% ropivacaine 13.3ml before surgery. | 35 |
| Femoral Block for ACL Reconstruction Patients scheduled for ACL reconstruction will have a sciatic nerve block and a femoral nerve block done using 0.5% ropivacaine 20ml before surgery. | 31 |
| Adductor Canal Block for ACL Reconstruction Patients scheduled for ACL reconstruction will have a sciatic nerve block and an adductor canal block done using 0.75% ropivacaine 13.3ml before surgery. | 30 |
| Total | 122 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 0 | 2 | 3 |
| Overall Study | Lost to follow up for primary outcome measurement d/t lack of time to complete before surgery | 1 | 1 | 1 | 3 |
Baseline characteristics
| Characteristic | Femoral Block for Knee Arthroscopy/Meniscus Surgery | Adductor Canal Block for Knee Arthroscopy/Meniscus Surgery | Femoral Block for ACL Reconstruction | Adductor Canal Block for ACL Reconstruction | Total |
|---|---|---|---|---|---|
| Age, Continuous | 39 years | 49 years | 35 years | 33.5 years | 36.5 years |
| BMI | 24.3 kg/m^2 | 28.3 kg/m^2 | 25.4 kg/m^2 | 24.4 kg/m^2 | 25.3 kg/m^2 |
| Race/Ethnicity, Customized Asian | 4 Participants | 8 Participants | 10 Participants | 5 Participants | 27 Participants |
| Race/Ethnicity, Customized Black | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 2 Participants | 4 Participants | 5 Participants | 1 Participants | 12 Participants |
| Race/Ethnicity, Customized Native American or Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 19 Participants | 21 Participants | 16 Participants | 24 Participants | 80 Participants |
| Sex: Female, Male Female | 8 Participants | 10 Participants | 14 Participants | 14 Participants | 46 Participants |
| Sex: Female, Male Male | 18 Participants | 25 Participants | 17 Participants | 16 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 35 | 0 / 33 | 0 / 33 |
| other Total, other adverse events | 0 / 31 | 0 / 35 | 0 / 33 | 0 / 33 |
| serious Total, serious adverse events | 0 / 31 | 0 / 35 | 0 / 33 | 0 / 33 |
Outcome results
Primary
Change in Quadriceps Strength Related to the Nerve Block
Quadriceps strength will be tested with a dynamometer before the nerve block and 20 minutes after the nerve block prior to surgery. The dynamometer measures the strength of the quadriceps muscles in the seated position while pushing against the device. We are trying to measure the effect of both femoral and adductor canal nerve blocks on quadriceps strength.
Time frame: Baseline and 20 minutes after the block prior to surgery
Population: The participants with data available are reported here.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Femoral Block for Knee Arthroscopy/Meniscus Surgery | Change in Quadriceps Strength Related to the Nerve Block | -0.42 Newtons |
| Adductor Canal Block for Knee Arthroscopy/Meniscus Surgery | Change in Quadriceps Strength Related to the Nerve Block | -0.55 Newtons |
| Femoral Block for ACL Reconstruction | Change in Quadriceps Strength Related to the Nerve Block | -3.19 Newtons |
| Adductor Canal Block for ACL Reconstruction | Change in Quadriceps Strength Related to the Nerve Block | -0.77 Newtons |
Secondary
Duration of Nerve Block
Patients will be contacted after surgery to determine when the nerve block wore off based on their increase in pain
Time frame: 8 to 24 hours
Population: The participants with data available are reported here.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Femoral Block for Knee Arthroscopy/Meniscus Surgery | Duration of Nerve Block | 678 minutes |
| Adductor Canal Block for Knee Arthroscopy/Meniscus Surgery | Duration of Nerve Block | 731 minutes |
| Femoral Block for ACL Reconstruction | Duration of Nerve Block | 889 minutes |
| Adductor Canal Block for ACL Reconstruction | Duration of Nerve Block | 923 minutes |
Secondary
Numerical Pain Score From 0-10
As this is an outpatient surgery, we will collect Numerical Pain Scores from the recovery room medical record after surgery as well as from the patients for the first 24 hours after surgery by contacting them at home the following day. We will evaluate the difference in patient pain scores between the two nerve blocks under study. The highest pain score for the 24-hour post-op period was collected for each participant. The median is reported for all participants. A pain score of 10 represents the worst pain.
Time frame: worse pain in first 24 hours
Population: The participants with data available are reported here.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Femoral Block for Knee Arthroscopy/Meniscus Surgery | Numerical Pain Score From 0-10 | 4.5 score on a scale |
| Adductor Canal Block for Knee Arthroscopy/Meniscus Surgery | Numerical Pain Score From 0-10 | 5 score on a scale |
| Femoral Block for ACL Reconstruction | Numerical Pain Score From 0-10 | 7 score on a scale |
| Adductor Canal Block for ACL Reconstruction | Numerical Pain Score From 0-10 | 6.5 score on a scale |
Secondary
Opioid Consumption Reported at mg of Morphine Equivalence
Data on the amount of pain medication consumed for the 1st 24 hours after surgery will be collected based on medications that were administered during surgery, in the recovery room and medications that patients took at home after discharge from the recovery room. All pain medications will be converted to morphine equivalence in milligrams and reported that way. The comparison will be the difference in mg morphine equivalence consumption between the two nerve block groups.
Time frame: 2 days
Population: The participants with data available are reported here.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Femoral Block for Knee Arthroscopy/Meniscus Surgery | Opioid Consumption Reported at mg of Morphine Equivalence | 40 Morphine milligram equivalents (MME) |
| Adductor Canal Block for Knee Arthroscopy/Meniscus Surgery | Opioid Consumption Reported at mg of Morphine Equivalence | 51.25 Morphine milligram equivalents (MME) |
| Femoral Block for ACL Reconstruction | Opioid Consumption Reported at mg of Morphine Equivalence | 20 Morphine milligram equivalents (MME) |
| Adductor Canal Block for ACL Reconstruction | Opioid Consumption Reported at mg of Morphine Equivalence | 20 Morphine milligram equivalents (MME) |