Postoperative Analgesia, Medial Unicompartmental Knee Arthroplasty
Conditions
Keywords
Partial knee replacement
Brief summary
This study will evaluate the affects of a single injection ultrasound-guided adductor canal block for patients undergoing robotic-assisted (MAKOplasty) medial UKA (unicompartmental knee arthroplasty). Specifically, this study will compare the adequacy of postoperative analgesia provided by the adductor canal block with that provided by single injection lumbar plexus blockade. The working hypothesis is that the analgesia provided by the adductor canal block will be equivalent to the analgesia provided by the lumbar plexus block. The primary outcome will be a comparison of verbal numerical pain scores at rest and with movement over the first 24 hours following nerve blockade.
Interventions
DRUGAdductor canal block
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 18-85 * Undergoing unilateral robotic-assisted (MAKOplasty) medial compartment knee arthroplasty at Wake Forest University Baptist Medical Center. * Must give written informed consent for anesthesia including subarachnoid blockade and peripheral nerve blockade of both the lumbar plexus and adductor canal. * Must consent to the performance of a sham block at the site to which they are not randomized. * Must also be reliable to give accurate verbal pain scores postoperatively.
Exclusion criteria
* Contraindication to adductor canal blockade or lumbar plexus blockade (including significant coagulation abnormalities) * History of opioid addiction or current chronic pain therapy for pain other than at the surgical site that is being treated with high-dose opioids (extended release opioids or \> 40mg oxycodone equivalents per day) * Allergy to study medications * Failure to adequately place either the adductor canal or lumbar plexus blocks. * Patients who decline or have a contraindication to subarachnoid blockade will also be excluded from the study. * Pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Verbal Pain Scores at 6 Hours Post Nerve Blockade. | 6 hours post block. | Comparison of verbal numerical pain scores at rest and with movement 6 hours following nerve blockade. The score range is 0-10 with higher scores denoting worse outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption | 6, 12, 18, and 24 hours | Comparison of cumulative opioid consumption over 24 hour period between adductor canal block and lumbar plexus block. |
| Time to First Analgesic | 24 hours | Time to first analgesic between two groups: adductor canal block and lumbar plexus block. |
| Opioid Related Side Effects | 6, 12, 18, and 24 hours | Occurrence of opioid related side effects (nausea, vomiting and pruritus) between two groups: adductor canal block and lumbar plexus block. |
| Quadriceps Motor Strength | 6 hours | Comparison of quadriceps motor strength at 6 hour post nerve block between two groups: adductor canal block and lumbar plexus block. The score range is 0-5, with higher scores denoting better outcomes. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adductor Canal Block Patients in this arm will receive an adductor canal block prior to undergoing a medial compartment knee arthroplasty.
Adductor canal block | 74 |
| Lumbar Plexus Block Patients in this arm will receive a lumbar plexus block prior to undergoing a medial compartment knee arthroplasty.
Lumbar plexus block | 73 |
| Total | 147 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawn for case delay after block | 1 | 0 |
| Overall Study | Withdrawn for failure to place block | 0 | 1 |
| Overall Study | Withdrawn for long-acting opioid patch | 0 | 1 |
Baseline characteristics
| Characteristic | Lumbar Plexus Block | Total | Adductor Canal Block |
|---|---|---|---|
| Age, Continuous | 63 years STANDARD_DEVIATION 10.5 | 63 years STANDARD_DEVIATION 10.4 | 63 years STANDARD_DEVIATION 10.2 |
| 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 | 10 Participants | 21 Participants | 11 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 | 63 Participants | 126 Participants | 63 Participants |
| Sex: Female, Male Female | 39 Participants | 72 Participants | 33 Participants |
| Sex: Female, Male Male | 34 Participants | 75 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 74 | 0 / 73 |
| other Total, other adverse events | 38 / 74 | 43 / 73 |
| serious Total, serious adverse events | 0 / 74 | 0 / 73 |
Outcome results
Primary
Verbal Pain Scores at 6 Hours Post Nerve Blockade.
Comparison of verbal numerical pain scores at rest and with movement 6 hours following nerve blockade. The score range is 0-10 with higher scores denoting worse outcomes.
Time frame: 6 hours post block.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adductor Canal Block | Verbal Pain Scores at 6 Hours Post Nerve Blockade. | rest | 1 score on a scale | Standard Deviation 2 |
| Adductor Canal Block | Verbal Pain Scores at 6 Hours Post Nerve Blockade. | movement | 1.6 score on a scale | Standard Deviation 2.6 |
| Lumbar Plexus Block | Verbal Pain Scores at 6 Hours Post Nerve Blockade. | rest | 1.1 score on a scale | Standard Deviation 2.2 |
| Lumbar Plexus Block | Verbal Pain Scores at 6 Hours Post Nerve Blockade. | movement | 1.5 score on a scale | Standard Deviation 2.8 |
Secondary
Opioid Consumption
Comparison of cumulative opioid consumption over 24 hour period between adductor canal block and lumbar plexus block.
Time frame: 6, 12, 18, and 24 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adductor Canal Block | Opioid Consumption | 6 hours | 1.5 mg | Standard Deviation 4.5 |
| Adductor Canal Block | Opioid Consumption | 12 hours | 11 mg | Standard Deviation 14.3 |
| Adductor Canal Block | Opioid Consumption | 18 hours | 20.9 mg | Standard Deviation 26.8 |
| Adductor Canal Block | Opioid Consumption | 24 hours | 27.9 mg | Standard Deviation 38.4 |
| Lumbar Plexus Block | Opioid Consumption | 24 hours | 32.1 mg | Standard Deviation 27.7 |
| Lumbar Plexus Block | Opioid Consumption | 6 hours | 2.5 mg | Standard Deviation 5.2 |
| Lumbar Plexus Block | Opioid Consumption | 18 hours | 20.7 mg | Standard Deviation 17.8 |
| Lumbar Plexus Block | Opioid Consumption | 12 hours | 10.3 mg | Standard Deviation 11.5 |
Secondary
Opioid Related Side Effects
Occurrence of opioid related side effects (nausea, vomiting and pruritus) between two groups: adductor canal block and lumbar plexus block.
Time frame: 6, 12, 18, and 24 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adductor Canal Block | Opioid Related Side Effects | Nausea 24 hours | 9 events |
| Adductor Canal Block | Opioid Related Side Effects | Vomiting 6 hours | 6 events |
| Adductor Canal Block | Opioid Related Side Effects | Nausea 6 hours | 14 events |
| Adductor Canal Block | Opioid Related Side Effects | Nausea 12 hours | 10 events |
| Adductor Canal Block | Opioid Related Side Effects | Nausea 18 hours | 5 events |
| Adductor Canal Block | Opioid Related Side Effects | Vomiting 12 hours | 6 events |
| Adductor Canal Block | Opioid Related Side Effects | Vomiting 18 hours | 2 events |
| Adductor Canal Block | Opioid Related Side Effects | Vomiting 24 hours | 4 events |
| Adductor Canal Block | Opioid Related Side Effects | Pruritus 6 hours | 11 events |
| Adductor Canal Block | Opioid Related Side Effects | Pruritus 12 hours | 7 events |
| Adductor Canal Block | Opioid Related Side Effects | Pruritus 18 hours | 5 events |
| Adductor Canal Block | Opioid Related Side Effects | Pruritus 24 hours | 10 events |
| Lumbar Plexus Block | Opioid Related Side Effects | Pruritus 18 hours | 5 events |
| Lumbar Plexus Block | Opioid Related Side Effects | Nausea 24 hours | 15 events |
| Lumbar Plexus Block | Opioid Related Side Effects | Vomiting 18 hours | 3 events |
| Lumbar Plexus Block | Opioid Related Side Effects | Pruritus 12 hours | 4 events |
| Lumbar Plexus Block | Opioid Related Side Effects | Nausea 6 hours | 15 events |
| Lumbar Plexus Block | Opioid Related Side Effects | Vomiting 24 hours | 6 events |
| Lumbar Plexus Block | Opioid Related Side Effects | Nausea 12 hours | 16 events |
| Lumbar Plexus Block | Opioid Related Side Effects | Pruritus 24 hours | 13 events |
| Lumbar Plexus Block | Opioid Related Side Effects | Nausea 18 hours | 8 events |
| Lumbar Plexus Block | Opioid Related Side Effects | Vomiting 6 hours | 8 events |
| Lumbar Plexus Block | Opioid Related Side Effects | Pruritus 6 hours | 3 events |
| Lumbar Plexus Block | Opioid Related Side Effects | Vomiting 12 hours | 6 events |
Secondary
Quadriceps Motor Strength
Comparison of quadriceps motor strength at 6 hour post nerve block between two groups: adductor canal block and lumbar plexus block. The score range is 0-5, with higher scores denoting better outcomes.
Time frame: 6 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adductor Canal Block | Quadriceps Motor Strength | 4 units on a scale | Standard Deviation 1.1 |
| Lumbar Plexus Block | Quadriceps Motor Strength | 2.5 units on a scale | Standard Deviation 1.3 |
Secondary
Time to First Analgesic
Time to first analgesic between two groups: adductor canal block and lumbar plexus block.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adductor Canal Block | Time to First Analgesic | 601 minutes | Standard Deviation 295 |
| Lumbar Plexus Block | Time to First Analgesic | 659 minutes | Standard Deviation 366 |