Adductor Canal Block for Medial Compartment Knee Arthroplasty

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Wake Forest Baptist Health
Sponsor:
Information provided by (Responsible Party):
Daryl Steven Henshaw, MD, Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier:
NCT01818531
First received: March 21, 2013
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Postoperative Analgesia
Medial Unicompartmental Knee Arthroplasty
Procedure: Adductor canal block
Procedure: Lumbar plexus block

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Ultrasound-Guided Adductor Canal Blockade for Postoperative Analgesia Following Robotic Medial Unicompartmental Knee Replacement

Resource links provided by NLM:


Further study details as provided by Wake Forest Baptist Health:

Primary Outcome Measures:
  • Verbal pain scores at 6 hours post nerve blockade. [ Time Frame: 6 hours post block. ] [ Designated as safety issue: No ]
    Comparison of verbal numerical pain scores at rest and with movement over the first 24 hours following nerve blockade.


Secondary Outcome Measures:
  • Opioid consumption [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Comparison of opioid consumption over 24 hour period between adductor canal block and lumbar plexus block.

  • Time to first analgesic [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Time to first analgesic between two groups: adductor canal block and lumbar plexus block.

  • Opioid related side effects [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Occurrence of opioid related side effects (nausea, vomiting and itching) between two groups: adductor canal block and lumbar plexus block.

  • Quadriceps motor strength [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    Comparison of quadriceps motor strength at 6 hour post nerve block between two groups: adductor canal block and lumbar plexus block.


Estimated Enrollment: 150
Study Start Date: April 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adductor canal block
Patients in this arm will receive an adductor canal block prior to undergoing a medial compartment knee arthroplasty.
Procedure: Adductor canal block
Other Name: Saphenous nerve block
Active Comparator: Lumbar plexus block
Patients in this arm will receive a lumbar plexus block prior to undergoing a medial compartment knee arthroplasty.
Procedure: Lumbar plexus block

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01818531

Contacts
Contact: Daryl S Henshaw, MD 3367164498 dhenshaw@wakehealth.edu

Locations
United States, North Carolina
Wake Forest University Baptist Medical Center Recruiting
Winston Salem, North Carolina, United States, 27157
Contact: Daryl S Henshaw, MC    336-716-4498    dhenshaw@wakehealth.edu   
Principal Investigator: Daryl S Henshaw, MD         
Sub-Investigator: Robert Weller, MD         
Sub-Investigator: Douglas Jaffe, DO         
Sub-Investigator: James Crews, MD         
Sub-Investigator: Jon Reynolds, MD         
Sponsors and Collaborators
Wake Forest Baptist Health
Investigators
Principal Investigator: Daryl S Henshaw, MD Wake Forest Baptist Health
  More Information

Publications:

Responsible Party: Daryl Steven Henshaw, MD, Assistant Professor, Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier: NCT01818531     History of Changes
Other Study ID Numbers: IRB00023002
Study First Received: March 21, 2013
Last Updated: May 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest Baptist Health:
Partial knee replacement

ClinicalTrials.gov processed this record on August 18, 2014