Diaphragmatic Breathing Exercises in Total Knee Arthroplasty Patients

Sponsor

University of Southern California (Other)

Overall Status

Unknown status

CT.gov ID

NCT04336579

Collaborator

(none)

Enrollment

9.1

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia and Analgesia	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 Design

Study Type:

Observational

Anticipated Enrollment :

48 participants

Observational Model:

Case-Control

Time Perspective:

Other

Official Title:

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

Anticipated Study Start Date :

May 1, 2020

Anticipated Primary Completion Date :

Feb 1, 2021

Anticipated Study Completion Date :

Feb 1, 2021

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Southern California

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Linda Rever, Clinical Associate Professor of Anesthesiology, University of Southern California

ClinicalTrials.gov Identifier:

NCT04336579

Other Study ID Numbers:

HS-19-00223

First Posted:

Apr 7, 2020

Last Update Posted:

Apr 8, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 8, 2020