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Completed

NCT Number: NCT03395990

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

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

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Key information

Conditions

Osteo Arthritis Knee Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

56 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Hospital

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active comparator: chloroprocaine

Procedure

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

Other names: femoral nerve block with chloroprocaine

Sham comparator: saline

Procedure

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

Other names: femoral nerve block with normal saline

Primary outcomes

  1. Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain.

    Time frame: Baseline, up to 30 minutes.

    Pain intensity prior to intervention and at 5 minute intervals after intervention. The 11-point Numeric Rating Scale quantifies a subject's pain experience from 0/10 (no pain) to 10/10 (worst pain imaginable).

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Evaluation of the Comparative Analgesic Value of Adductor Canal Block Versus Femoral Block Following Total Knee Arthroplasty

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 10, 2018
Registry last updated
Jun 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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