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NCT Number: NCT04336579

Diaphragmatic Breathing Exercises in Total Knee Arthroplasty Patients

Rationale: While total knee replacements (TKA) are one of the most commonly performed surgical procedures in the United States, this procedure can also be very painful. Postoperative mobilization and rehabilitation is vital to a patient's recovery, but inadequate pain control can impede patients' progress. Diaphragmatic breathing is an additional non-pharmacological and non-invasive tool with no adverse effects that could aid in recovery. This will serve as a pilot study for a possible larger controlled trials.

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Key information

Conditions

Anesthesia and Analgesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Keck Hospital of USC

Los Angeles, California, 90033, United States

Location status: Recruiting

About this study

Study population: Patients (participants) undergoing total knee arthroplasty at Keck USC Hospital at HC3

Study methodology: Patients (participants) will be taught with the aide of a handout and instructional videos preoperatively and in the recovery room on how to perform diaphragmatic breathing exercises for post-operative pain control. Patient (participant) pain levels will be assessed using the visual analog scale (VAS). The investigators will then be comparing VAS scores and daily opioid doses (morphine equivalents) between the study group and a control group. The control group will include prior patients (participants) over the past year who underwent TKA at Keck Hospital and also had pain scores and opioid usage measured, but did not receive the breathing treatment.

Study endpoints: Endpoints will include: pain levels via VAS scale, anxiety levels via VAS scale, and opioid usage (morphine equivalents).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients (participants) undergoing total knee arthroplasty with a continuous peripheral nerve block catheter

Exclusion criteria

  • Inability to perform or learn diaphragmatic breathing exercises or do not wish to participate in diaphragmatic breathing or study protocol
  • Pregnant patients
  • Patients without continuous peripheral nerve block catheter

Treatment and study plan

Diaphragmatic breathing

Behavioral

Simple diaphragmatic breathing exercise

Primary outcomes

  1. Pain Level

    Time frame: Prior to intervention

    Verbal Analog Pain Score - rate pain on 0-10 scale where 0=no pain, 10= worst possible pain

  2. Opioid Usage (morphine equivalents)

    Time frame: Prior to intervention

    Opioid Usage for pain

  3. Anxiety Level

    Time frame: Prior to intervention

    Verbal Analog Score -rate anxiety on 0-10 scale where 0= no anxiety, 10= worst possible anxiety

  4. Pain Level

    Time frame: 15 minutes after intervention

    Verbal Analog Pain Score - rate pain on 0-10 scale where 0 =no pain, 10 = worst possible pain

  5. Opioid Usage (morphine equivalents)

    Time frame: 15 minutes after intervention

    Opioid Usage for pain

  6. Anxiety Level

    Time frame: 15 minutes after intervention

    Verbal Analog Score - rate anxiety on 0-10 scale where 0 =no anxiety, 10 = worst possible anxiety

  7. Pain Level

    Time frame: 6 hours after intervention

    Verbal Analog Pain Score - rate pain on 0-10 scale where 0 =no pain, 10 = worst possible pain

  8. Opioid Usage (morphine equivalents)

    Time frame: 6 hours after intervention

    Opioid Usage for pain

  9. Anxiety Level

    Time frame: 6 hours after intervention

    Verbal Analog Score- rate anxiety on 0-10 scale where 0 =no anxiety, 10 = worst possible anxiety

  10. Pain Level

    Time frame: 1 day after intervention

    Verbal Analog Pain Score - rate pain on 0-10 scale where 0 =no pain, 10 = worst possible pain

  11. Opioid Usage (morphine equivalents)

    Time frame: 1 day after intervention

    Opioid Usage for pain

  12. Anxiety Level

    Time frame: 1 day after intervention

    Verbal Analog Score - rate anxiety on 0-10 scale where 0 = no anxiety, 10 = worst possible pain

Study contacts

Contact information is provided by the study sponsor or research team.

Linda J Rever, MD

CONTACT

[email protected]

3234427400

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

Diaphragmatic Breathing Exercises As An Analgesia Adjunct in Total Knee Arthroplasty Patients in the Perioperative Period

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 7, 2020
Registry last updated
Aug 27, 2024

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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