Diaphragmatic Breathing Exercises in Total Knee Arthroplasty Patients

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

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.

Study Overview

• Status: Unknown
• Conditions: Anesthesia and Analgesia
• Intervention / Treatment: Behavioral: Diaphragmatic Breathing

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).

• Study Type: Observational
• Enrollment (Anticipated): 48

Contacts and Locations

• Study Contact: Name: LInda J Rever, MD; Phone Number: 3234094597; Email: rever@usc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control; Retrospective review of patients (participants) with standard analgesia post total knee arthroplasty
Diaphragmatic Breathing; Intervention: Participants will perform diaphragmatic breathing exercises postoperatively as part of their multi-modal pain regimen.	Behavioral: Diaphragmatic Breathing; Simple diaphragmatic breathing exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Level	Verbal Analog Pain Score - rate pain on 0-10 scale where 0=no pain, 10= worst possible pain	Prior to intervention
Opioid Usage (morphine equivalents)	Opioid Usage for pain	Prior to intervention
Anxiety Level	Verbal Analog Score -rate anxiety on 0-10 scale where 0= no anxiety, 10= worst possible anxiety	Prior to intervention
Pain Level	Verbal Analog Pain Score - rate pain on 0-10 scale where 0 =no pain, 10 = worst possible pain	15 minutes after intervention
Opioid Usage (morphine equivalents)	Opioid Usage for pain	15 minutes after intervention
Anxiety Level	Verbal Analog Score - rate anxiety on 0-10 scale where 0 =no anxiety, 10 = worst possible anxiety	15 minutes after intervention
Pain Level	Verbal Analog Pain Score - rate pain on 0-10 scale where 0 =no pain, 10 = worst possible pain	6 hours after intervention
Opioid Usage (morphine equivalents)	Opioid Usage for pain	6 hours after intervention
Anxiety Level	Verbal Analog Score- rate anxiety on 0-10 scale where 0 =no anxiety, 10 = worst possible anxiety	6 hours after intervention
Pain Level	Verbal Analog Pain Score - rate pain on 0-10 scale where 0 =no pain, 10 = worst possible pain	1 day after intervention
Opioid Usage (morphine equivalents)	Opioid Usage for pain	1 day after intervention
Anxiety Level	Verbal Analog Score - rate anxiety on 0-10 scale where 0 = no anxiety, 10 = worst possible pain	1 day after intervention

Collaborators and Investigators

• Sponsor: University of Southern California
• Investigators: Principal Investigator: Linda J Rever, MD, University of Southern California

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2020
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: April 2, 2020
• First Posted (Actual): April 7, 2020

Study Record Updates

• Last Update Posted (Actual): April 8, 2020
• Last Update Submitted That Met QC Criteria: April 6, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: HS-19-00223

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No