Adductor Canal Block for Medial Compartment Knee Arthroplasty

Phase 4

Completed

• Conditions: Postoperative Analgesia; Medial Unicompartmental Knee Arthroplasty
• Interventions: Drug: Adductor canal block; Drug: Lumbar plexus block

• Registration Number: NCT01818531
• Lead Sponsor: Wake Forest University Health Sciences

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-03-21
• Study First Submitted QC: 2013-03-21
• Study First Posted: 2013-03-26
• Study Start: 2013-04
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Results First Submitted: 2018-08-14
• Status Verified: 2018-09
• Results First Submitted QC: 2018-09-12
• Last Update Submitted: 2018-09-12
• Results First Posted: 2018-09-13
• Last Update Posted: 2018-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adductor canal block	Adductor canal block	Patients in this arm will receive an adductor canal block prior to undergoing a medial compartment knee arthroplasty.
Lumbar plexus block	Lumbar plexus block	Patients in this arm will receive a lumbar plexus block prior to undergoing a medial compartment knee arthroplasty.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Wake Forest University Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States