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Recruiting NCT04336579

Diaphragmatic Breathing Exercises in Total Knee Arthroplasty Patients

Observational Anesthesia and Analgesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diaphragmatic Breathing.
Who it may be relevant to
Registry conditions: Anesthesia and Analgesia. Basic parameters: 50 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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).

Interventions

  • Behavioral Diaphragmatic Breathing
    Simple diaphragmatic breathing exercise

Primary outcome measures

  • Pain Level [Time frame: Prior to intervention]
  • Opioid Usage (morphine equivalents) [Time frame: Prior to intervention]
  • Anxiety Level [Time frame: Prior to intervention]
  • Pain Level [Time frame: 15 minutes after intervention]
  • Opioid Usage (morphine equivalents) [Time frame: 15 minutes after intervention]
  • Anxiety Level [Time frame: 15 minutes after intervention]
  • Pain Level [Time frame: 6 hours after intervention]
  • Opioid Usage (morphine equivalents) [Time frame: 6 hours after intervention]
  • Anxiety Level [Time frame: 6 hours after intervention]
  • Pain Level [Time frame: 1 day after intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • Keck Hospital of USC — Los Angeles

Identifiers

NCT: NCT04336579 · HS-19-00223

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗