Analgesic Value of Adductor Canal vs Femoral Block After Total Knee Arthroplasty

NCT ID: NCT03395990

Last Updated: 2020-06-17

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

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-27

Study Completion Date

2016-10-19

Brief Summary

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An observational study of the effect of femoral nerve block in addition to an adductor canal block for pain following total knee arthroplasty.

Detailed Description

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Subjects undergoing total knee arthroplasty will receive a preoperative adductor canal block with continuous catheter. Following a standardized general anesthetic for the procedure, subjects will be asked to rate their pain using the NRS-11 pain scale in the recovery room. Once the pain is reported at a 5/10 or above, a femoral nerve block will be performed using either 2% chloroprocaine or saline placebo (randomized). Pain scores are then evaluated over the next 30 minutes by a blinded investigator to determine if the femoral block adds any additional analgesic benefit over an adductor canal block.

Conditions

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Osteo Arthritis Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized, blinded observational study
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
Group allocation by sealed envelope; unblinded investigator prepared syringes of study drug (chloroprocaine vs. saline), which look identical to blinded investigator and assessor.

Study Groups

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chloroprocaine

15 ml of 2% chloroprocaine via a femoral nerve block technique

Group Type ACTIVE_COMPARATOR

Active comparator: chloroprocaine

Intervention Type PROCEDURE

15 ml of 2% chloroprocaine was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb.

saline

15 ml of 0.9% saline via a femoral nerve block technique

Group Type SHAM_COMPARATOR

Sham comparator: saline

Intervention Type PROCEDURE

15 ml of normal saline was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb.

Interventions

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Active comparator: chloroprocaine

15 ml of 2% chloroprocaine was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb.

Intervention Type PROCEDURE

Sham comparator: saline

15 ml of normal saline was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb.

Intervention Type PROCEDURE

Other Intervention Names

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femoral nerve block with chloroprocaine femoral nerve block with normal saline

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled for elective total knee arthroplasty
* ASA Physical Status I-III
* BMI 18-40 kg/m2

Exclusion Criteria

* Inability to cooperate with protocol
* Inability to understand or speak English
* Allergy to any local anesthetic
* Chronic opioid consumption/abuse (30 or more morphine mg equivalents/day)
* Contraindication to adductor canal or femoral nerve block
Minimum Eligible Age

56 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeff Gadsden, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Hospital

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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PRO00067430

Identifier Type: -

Identifier Source: org_study_id

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