NCT01818531

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 26, 2013

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

September 13, 2018

Completed
Last Updated

September 13, 2018

Status Verified

September 1, 2018

Enrollment Period

2.1 years

First QC Date

March 21, 2013

Results QC Date

August 14, 2018

Last Update Submit

September 12, 2018

Conditions

Postoperative AnalgesiaMedial Unicompartmental Knee Arthroplasty

Keywords

Partial knee replacement

Outcome Measures

Primary Outcomes (1)

  • Verbal Pain Scores at 6 Hours Post Nerve Blockade.

    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.

    6 hours post block.

Secondary Outcomes (4)

  • Opioid Consumption

    6, 12, 18, and 24 hours

  • Time to First Analgesic

    24 hours

  • Opioid Related Side Effects

    6, 12, 18, and 24 hours

  • Quadriceps Motor Strength

    6 hours

Study Arms (2)

Adductor canal block

EXPERIMENTAL

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

Drug: Adductor canal block

Lumbar plexus block

ACTIVE COMPARATOR

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

Drug: Lumbar plexus block

Interventions

Adductor canal blockDRUG
Also known as: Saphenous nerve block
Adductor canal block
Lumbar plexus blockDRUG
Lumbar plexus block

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (10)

  • Meek RM, Masri BA, Duncan CP. Minimally invasive unicompartmental knee replacement: rationale and correct indications. Orthop Clin North Am. 2004 Apr;35(2):191-200. doi: 10.1016/S0030-5898(03)00115-9.

    PMID: 15062705BACKGROUND

  • Riddle DL, Jiranek WA, McGlynn FJ. Yearly incidence of unicompartmental knee arthroplasty in the United States. J Arthroplasty. 2008 Apr;23(3):408-12. doi: 10.1016/j.arth.2007.04.012. Epub 2007 Nov 26.

    PMID: 18358380BACKGROUND

  • Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.

    PMID: 17403800BACKGROUND

  • GARDNER E. The innervation of the knee joint. Anat Rec. 1948 May;101(1):109-30. doi: 10.1002/ar.1091010111. No abstract available.

    PMID: 18915634BACKGROUND

  • Davis JJ, Bond TS, Swenson JD. Adductor canal block: more than just the saphenous nerve? Reg Anesth Pain Med. 2009 Nov-Dec;34(6):618-9. doi: 10.1097/AAP.0b013e3181bfbf00. No abstract available.

    PMID: 19901788BACKGROUND

  • Horner G, Dellon AL. Innervation of the human knee joint and implications for surgery. Clin Orthop Relat Res. 1994 Apr;(301):221-6.

    PMID: 8156678BACKGROUND

  • Jenstrup MT, Jaeger P, Lund J, Fomsgaard JS, Bache S, Mathiesen O, Larsen TK, Dahl JB. Effects of adductor-canal-blockade on pain and ambulation after total knee arthroplasty: a randomized study. Acta Anaesthesiol Scand. 2012 Mar;56(3):357-64. doi: 10.1111/j.1399-6576.2011.02621.x. Epub 2012 Jan 4.

    PMID: 22221014BACKGROUND

  • Lund J, Jenstrup MT, Jaeger P, Sorensen AM, Dahl JB. Continuous adductor-canal-blockade for adjuvant post-operative analgesia after major knee surgery: preliminary results. Acta Anaesthesiol Scand. 2011 Jan;55(1):14-9. doi: 10.1111/j.1399-6576.2010.02333.x. Epub 2010 Oct 29.

    PMID: 21039357BACKGROUND

  • Farrar JT, Berlin JA, Strom BL. Clinically important changes in acute pain outcome measures: a validation study. J Pain Symptom Manage. 2003 May;25(5):406-11. doi: 10.1016/s0885-3924(03)00162-3.

    PMID: 12727037BACKGROUND

  • Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419.

    PMID: 3450848BACKGROUND

Results Point of Contact

Title
Dr. Daryl Henshaw
Organization
Wake Forest University Health Sciences
dhenshaw@wakehealth.edu
3367166344

Study Officials

  • Daryl S Henshaw, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2013

First Posted

March 26, 2013

Study Start

April 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

September 13, 2018

Results First Posted

September 13, 2018

Record last verified: 2018-09

Locations

US(1)