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Completed

NCT Number: NCT01818531

Adductor Canal Block for Medial Compartment Knee Arthroplasty

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.

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Key information

Conditions

Postoperative Analgesia Medial Unicompartmental Knee Arthroplasty

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adductor Canal Block

Drug

Other names: Saphenous nerve block

Lumbar plexus block

Drug

Primary outcomes

  1. 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

  1. Opioid Consumption

    Time frame: 6, 12, 18, and 24 hours

    Comparison of cumulative opioid consumption over 24 hour period between adductor canal block and lumbar plexus block.

  2. Time to First Analgesic

    Time frame: 24 hours

    Time to first analgesic between two groups: adductor canal block and lumbar plexus block.

  3. Opioid Related Side Effects

    Time frame: 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.

  4. Quadriceps Motor Strength

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 26, 2013
Registry last updated
Sep 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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