Nerve Block, Postoperative Pain, Total Knee Arthroplasty
Conditions
Keywords
anesthesiology, pain, arthroplasty
Brief summary
Do ultrasound-guided genicular nerve blocks with 0.5% bupivacaine provide improved knee analgesia for patients recovering from total knee replacement surgery compared to saline injection? Hypotheses: The investigators hypothesize that the combination of ultrasound-guided adductor canal block (ACB) and genicular nerve block will achieve lower opioid consumption and therefore lead to decreased systemic side effects and improved overall satisfaction compared to ultrasound-guided saline injection for patients undergoing minimally invasive elective total knee arthroplasty (TKA).
Detailed description
The study medication and protocol will consist of Group 1 (Active) - ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine and ultrasound-guided genicular nerve blocks with 6 ml of 0.5% bupivacaine, and Group 2 (Control) - ultrasound-guided adductor canal block with 10 ml of 0.25% bupivacaine and ultrasound-guided genicular nerve blocks with 6 ml of normal saline. The surgeon will be blinded to the subjects study arm assignment. An ultrasound-guided ACB will be performed at the level of the mid-thigh of the leg halfway between the superior anterior iliac spine and the patella. The femoral artery, femoral vein, saphenous nerve will be visualized by ultrasonography and the expansion of the adductor canal will be recorded. Sensory assessment of the saphenous distribution will be performed at 30 minutes. The ultrasound-guided genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. The superior lateral genicular nerve is located at the confluence of the lateral femoral shaft and the lateral femoral condyle (in the anteroposterior plane) and at the midpoint of the femur (in the lateral plane). The superior medial genicular nerve site is located at the confluence of the medial femoral shaft and the medial femoral condyle (in the anteroposterior plane) and at the midpoint of the femur (in the lateral plane). The inferior medial genicular nerve site is located at the confluence of the medial tibial shaft and the tibial flare (in the anteroposterior plane) and the midpoint of the tibia (in the lateral plane). Color Doppler will be used to identify the arterial structures which serve as landmarks for the corresponding nerves. All nerve blocks will be performed by a study team physician. Postoperative follow-up will be done by study team member blinded to the group allocation. The dosing of oxycodone/hydrocodone-acetaminophen will be as needed with management goal of a Visual Analog Scale (VAS) score of ≤ 4. Patients with pain not managed by oral agents will receive IV medication. Patients will be visited during their hospital stay every six hours until discharge to record pain scores, opioid consumption, and patient satisfaction. In addition, patients will be given a pain diary to record (VAS) pain scores every six hours until hospital discharge. A study team member will follow up patients by telephone (if discharged prior to) at 48 hours, 72 hours.
Interventions
DRUGbupivacaine
Group 1 will receive genicular nerve block using bupivacaine
DRUGsaline
Group 2 will receive genicular nerve block using normal saline
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Participants 40 to 85 years old who are presenting for minimally invasive total knee arthroplasty under spinal anesthesia and are candidates for peripheral nerve blocks. * Minimally invasive is defined as custom modified instrumentation, a quadriceps sparing arthrotomy that does not extend beyond 1cm proximal to the patella and surgical techniques that focus on soft tissue protection.
Exclusion criteria
* Patient refusal * American Society of Anesthesiologists physical status classification of 4 or higher * Pre-existing neuropathy in the femoral or sciatic distribution * Coagulopathy * Infection at the site * Chronic opioid use (greater than 3 months) * Pregnancy * Medical conditions limiting physical therapy participation * Any other contra-indication to regional anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Opioid Consumption During the Hospital Stay | 36 hours after surgery | Post-operative opioid consumption measured in morphine milligram equivalents (MME)during the hospital stay up to 36 hours after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Pain Scores of the Knee at Rest for the First 48 Hours After Surgery | 48 hours after surgery | Mean pain scores post operative reported using the VAS (visual analog scale) for knee pain at rest on a scale of 0 (no pain to 10 worst pain imaginable). This will be assessed every 6 hours up to 48 hours with the visual analog scale where 0 equals no pain and 10 represents excruciating pain. |
| Overall Satisfaction With Pain Control 72 Hours After Surgery | 72 hours after surgery | Overall satisfaction with pain control 72 hours after surgery using a visual analog scale where 0 = not satisfied and 10 being extremely satisfied |
| Length of Hospitalization | Admission to discharge from hospital | Length of hospitalization in hours from time to admission to time of discharge. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Patient will receive genicular nerve block with bupivacaine
bupivacaine: Group 1 will receive genicular nerve block using bupivacaine | 2 |
| Group 2 Patient will receive normal saline as the nerve block
saline: Group 2 will receive genicular nerve block using normal saline | 0 |
| Total | 2 |
Baseline characteristics
| Characteristic | Total | Group 1 |
|---|---|---|
| Age, Continuous | 71.5 Years | 71.5 Years |
| Height Inches | 66.5 Inches | 66.5 Inches |
| Kilograms (kG) weight | 95.8 Kilograms | 95.8 Kilograms |
| Pre Surgical Baseline Pain at Rest | 3 Units on a scale | 3 Units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 2 Participants |
| Region of Enrollment United States | 2 participants | 2 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 0 |
| other Total, other adverse events | 1 / 2 | 0 / 0 |
| serious Total, serious adverse events | 0 / 2 | 0 / 0 |
Outcome results
Primary
Post-operative Opioid Consumption During the Hospital Stay
Post-operative opioid consumption measured in morphine milligram equivalents (MME)during the hospital stay up to 36 hours after surgery.
Time frame: 36 hours after surgery
Population: Only two subjects enrolled both were randomized to group 1.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 1 | Post-operative Opioid Consumption During the Hospital Stay | 24.17 Morphine milligram equivalents (MME) |
Secondary
Length of Hospitalization
Length of hospitalization in hours from time to admission to time of discharge.
Time frame: Admission to discharge from hospital
Population: Study was terminated early due to low enrollment. No subjects were randomized to group 2.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 1 | Length of Hospitalization | 38.29 Elapsed time in hours |
Secondary
Mean Pain Scores of the Knee at Rest for the First 48 Hours After Surgery
Mean pain scores post operative reported using the VAS (visual analog scale) for knee pain at rest on a scale of 0 (no pain to 10 worst pain imaginable). This will be assessed every 6 hours up to 48 hours with the visual analog scale where 0 equals no pain and 10 represents excruciating pain.
Time frame: 48 hours after surgery
Population: Study terminated due to low enrollment. No subjects randomized to group 2.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 1 | Mean Pain Scores of the Knee at Rest for the First 48 Hours After Surgery | 3.05 score on a scale |
Secondary
Overall Satisfaction With Pain Control 72 Hours After Surgery
Overall satisfaction with pain control 72 hours after surgery using a visual analog scale where 0 = not satisfied and 10 being extremely satisfied
Time frame: 72 hours after surgery
Population: Study terminated early due to low enrollment. No subjects were randomized to group 2.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 1 | Overall Satisfaction With Pain Control 72 Hours After Surgery | 7 score on a scale |