Clinical trial NCT04336579: Diaphragmatic Breathing Exercises in Total Knee Arthroplasty Patients
Official title: Diaphragmatic Breathing Exercises As An Analgesia Adjunct in Total Knee Arthroplasty Patients in the Perioperative Period
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anesthesia and Analgesia
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2020-04-07
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients (participants) undergoing total knee arthroplasty with placement of continuous peripheral nerve block catheter between the ages of 50-90 years of age at the Keck Hospital of USC who want to participate and consent to participate in the study. The control group will be made up of patients( 50-90 years of age) who underwent total knee arthroplasty with placement of a continuous peripheral nerve block catheter over the year prior, without participation in breathing exercises, at the Keck Hospital of USC.

Brief summary: 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).

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

Primary outcomes:
measure: Pain Level
timeFrame: Prior to intervention
measure: Opioid Usage (morphine equivalents)
timeFrame: Prior to intervention
measure: Anxiety Level
timeFrame: Prior to intervention
measure: Pain Level
timeFrame: 15 minutes after intervention
measure: Opioid Usage (morphine equivalents)
timeFrame: 15 minutes after intervention
measure: Anxiety Level
timeFrame: 15 minutes after intervention
measure: Pain Level
timeFrame: 6 hours after intervention
measure: Opioid Usage (morphine equivalents)
timeFrame: 6 hours after intervention
measure: Anxiety Level
timeFrame: 6 hours after intervention
measure: Pain Level
timeFrame: 1 day after intervention
measure: Opioid Usage (morphine equivalents)
timeFrame: 1 day after intervention
measure: Anxiety Level
timeFrame: 1 day after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck Hospital of USC
state: California
Study officials:
affiliation: University of Southern California
name: Linda J Rever, MD
role: PRINCIPAL_INVESTIGATOR
References: