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Clinical Trials/NCT01818531
NCT01818531
Completed
Phase 4

Evaluation of Ultrasound-Guided Adductor Canal Blockade for Postoperative Analgesia Following Robotic Medial Unicompartmental Knee Replacement

Wake Forest University Health Sciences1 site in 1 country150 target enrollmentApril 2013

Overview

Phase
Phase 4
Intervention
Adductor canal block
Conditions
Postoperative Analgesia
Sponsor
Wake Forest University Health Sciences
Enrollment
150
Locations
1
Primary Endpoint
Verbal Pain Scores at 6 Hours Post Nerve Blockade.
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2013
End Date
May 2015
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Arms & Interventions

Adductor canal block

Patients in this arm will receive an adductor canal block prior to undergoing a medial compartment knee arthroplasty.

Intervention: Adductor canal block

Lumbar plexus block

Patients in this arm will receive a lumbar plexus block prior to undergoing a medial compartment knee arthroplasty.

Intervention: Lumbar plexus block

Outcomes

Primary Outcomes

Verbal Pain Scores at 6 Hours Post Nerve Blockade.

Time Frame: 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 Outcomes

  • Quadriceps Motor Strength(6 hours)
  • Opioid Related Side Effects(6, 12, 18, and 24 hours)
  • Opioid Consumption(6, 12, 18, and 24 hours)
  • Time to First Analgesic(24 hours)

Study Sites (1)

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