Ultrasound-guided Adductor Canal Block for Total Knee Replacement

NCT ID: NCT02100579

Last Updated: 2017-07-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-12-31

Brief Summary

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Total knee arthroplasty is associated with intense early postoperative pain. Fast track recovery programs including early therapy protocols and early hospital discharge are being implemented at various hospitals. The postoperative analgesic pain regimen should enhance functional recovery in addition to providing efficient analgesia with minimal side effects. Adductor canal blockade is commonly used to provide postoperative analgesia for total knee arthroplasty (TKA) surgery. The investigators hypothesize that an ultrasound guided adductor canal block will lower narcotic consumption and improved overall satisfaction compared to ultrasound guided sham block with normal saline (placebo) for patients undergoing minimally invasive TKA surgery.

Detailed Description

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The investigators hypothesize that an ultrasound guided adductor canal block will lower narcotic consumption and improved overall satisfaction compared to ultrasound guided sham block with normal saline (placebo) for patients undergoing minimally invasive TKA surgery.

Conditions

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Complications; Arthroplasty Knee Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Active Group

Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

10 ml of 0.25% bupivacaine

Control Group

Ultrasound-guided sham block with 10 ml of preservative free normal saline

Group Type PLACEBO_COMPARATOR

Preservative free normal saline

Intervention Type DRUG

10 ml of preservative free normal saline

Interventions

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Bupivacaine

10 ml of 0.25% bupivacaine

Intervention Type DRUG

Preservative free normal saline

10 ml of preservative free normal saline

Intervention Type DRUG

Other Intervention Names

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Sensorcaine 0.9% sodium chloride

Eligibility Criteria

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Inclusion Criteria

* Participants 40 to 75 years old who are presenting for minimally invasive total knee arthroplasty under spinal anesthesia

Exclusion Criteria

* Patient refusal
* American Society of Anesthesiologists physical status classification of 4 or higher
* Pre-existing neuropathy in the femoral or sciatic distribution
* Coagulopathy
* Infection at the site
* Chronic opioid use (greater than 3 months)
* Pregnancy
* Medical conditions limiting physical therapy participation
* Any other contra-indication to regional anesthesia
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Antoun Nader

Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antoun Nader, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University Feinberg School of Medicine

Locations

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Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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STU00088239

Identifier Type: OTHER

Identifier Source: secondary_id

STU00088239

Identifier Type: -

Identifier Source: org_study_id

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