Adductor Canal Block for Medial Compartment Knee Arthroplasty

NCT ID: NCT01818531

Last Updated: 2018-09-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-05-31

Brief Summary

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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

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Conditions

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Postoperative Analgesia Medial Unicompartmental Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Adductor canal block

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

Group Type EXPERIMENTAL

Adductor canal block

Intervention Type DRUG

Lumbar plexus block

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

Group Type ACTIVE_COMPARATOR

Lumbar plexus block

Intervention Type DRUG

Interventions

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Adductor canal block

Intervention Type DRUG

Lumbar plexus block

Intervention Type DRUG

Other Intervention Names

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Saphenous nerve block

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daryl S Henshaw, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15062705 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18358380 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17403800 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 18915634 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19901788 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 8156678 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22221014 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21039357 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12727037 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3450848 (View on PubMed)

Other Identifiers

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IRB00023002

Identifier Type: -

Identifier Source: org_study_id

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