Clinical trial NCT01818531: Adductor Canal Block for Medial Compartment Knee Arthroplasty
Official title: Evaluation of Ultrasound-Guided Adductor Canal Blockade for Postoperative Analgesia Following Robotic Medial Unicompartmental Knee Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Analgesia
Medial Unicompartmental Knee Arthroplasty
Keywords: Partial knee replacement
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2013-03-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Verbal Pain Scores at 6 Hours Post Nerve Blockade.
timeFrame: 6 hours post block.
Secondary outcomes:
measure: Opioid Consumption
timeFrame: 6, 12, 18, and 24 hours
measure: Time to First Analgesic
timeFrame: 24 hours
measure: Opioid Related Side Effects
timeFrame: 6, 12, 18, and 24 hours
measure: Quadriceps Motor Strength
timeFrame: 6 hours
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Daryl S Henshaw, MD
role: PRINCIPAL_INVESTIGATOR
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