A Phase 4 interventional study of Adductor canal block and Lumbar plexus block in Postoperative Analgesia and Medial Unicompartmental Knee Arthroplasty, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-09-13.
Sponsored by Wake Forest University Health Sciences · Phase 4, Interventional, and Treatment
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.
Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
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Exclusion Criteria:
Patients in this arm will receive an adductor canal block prior to undergoing a medial compartment knee arthroplasty.
Drug: Adductor canal block
Patients in this arm will receive a lumbar plexus block prior to undergoing a medial compartment knee arthroplasty.
Drug: Lumbar plexus block
Also known as: Saphenous nerve block
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.
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
Time to First Analgesic
Time to first analgesic between two groups: adductor canal block and lumbar plexus block.
Time frame: 24 hours
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
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
| Milestone | Adductor Canal Block | Lumbar Plexus Block |
|---|---|---|
| Started | 75 | 75 |
| Completed | 74 | 73 |
| Not completed | 1 | 2 |
| Withdrew: Withdrawn for case delay after block | 1 | 0 |
| Withdrew: Withdrawn for long-acting opioid patch | 0 | 1 |
| Withdrew: Withdrawn for failure to place block | 0 | 1 |
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.
| score on a scale | Adductor Canal Block | Lumbar Plexus Block |
|---|---|---|
| rest | 1 ± 2 | 1.1 ± 2.2 |
| movement | 1.6 ± 2.6 | 1.5 ± 2.8 |
Comparison of cumulative opioid consumption over 24 hour period between adductor canal block and lumbar plexus block.
| mg | Adductor Canal Block | Lumbar Plexus Block |
|---|---|---|
| 6 hours | 1.5 ± 4.5 | 2.5 ± 5.2 |
| 12 hours | 11 ± 14.3 | 10.3 ± 11.5 |
| 18 hours | 20.9 ± 26.8 | 20.7 ± 17.8 |
| 24 hours | 27.9 ± 38.4 | 32.1 ± 27.7 |
Time to first analgesic between two groups: adductor canal block and lumbar plexus block.
| minutes | Adductor Canal Block | Lumbar Plexus Block |
|---|---|---|
| Time to First Analgesic | 601 ± 295 | 659 ± 366 |
Occurrence of opioid related side effects (nausea, vomiting and pruritus) between two groups: adductor canal block and lumbar plexus block.
| events | Adductor Canal Block | Lumbar Plexus Block |
|---|---|---|
| Nausea 6 hours | 14 | 15 |
| Nausea 12 hours | 10 | 16 |
| Nausea 18 hours | 5 | 8 |
| Nausea 24 hours | 9 | 15 |
| Vomiting 6 hours | 6 | 8 |
| Vomiting 12 hours | 6 | 6 |
| Vomiting 18 hours | 2 | 3 |
| Vomiting 24 hours | 4 | 6 |
| Pruritus 6 hours | 11 | 3 |
| Pruritus 12 hours | 7 | 4 |
| Pruritus 18 hours | 5 | 5 |
| Pruritus 24 hours | 10 | 13 |
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.
| units on a scale | Adductor Canal Block | Lumbar Plexus Block |
|---|---|---|
| Quadriceps Motor Strength | 4 ± 1.1 | 2.5 ± 1.3 |
Collected over 24 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adductor Canal Block | 0/74 (0%) | 0/74 (0%) | 38/74 (51.4%) |
| Lumbar Plexus Block | 0/73 (0%) | 0/73 (0%) | 43/73 (58.9%) |
| Event | Adductor Canal Block | Lumbar Plexus Block |
|---|---|---|
| NauseaGastrointestinal disorders | 25/74 | 32/73 |
| PruritusSkin and subcutaneous tissue disorders | 20/74 | 16/73 |
| VomittingGastrointestinal disorders | 15/74 | 16/73 |
| Age, Continuous(years) | Adductor Canal Block | Lumbar Plexus Block | Total |
|---|---|---|---|
| Mean | 63 ± 10.2 | 63 ± 10.5 | 63 ± 10.4 |
| Sex: Female, Male(Participants) | Adductor Canal Block | Lumbar Plexus Block | Total |
|---|---|---|---|
| Female | 33 | 39 | 72 |
| Male | 41 | 34 | 75 |
| Race (NIH/OMB)(Participants) | Adductor Canal Block | Lumbar Plexus Block | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 11 | 10 | 21 |
| White | 63 | 63 | 126 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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