NCT04336579

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 7, 2020

Completed
4.2 years until next milestone

Study Start

First participant enrolled

June 10, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

December 19, 2019

Last Update Submit

August 25, 2024

Conditions

Anesthesia and Analgesia

Outcome Measures

Primary Outcomes (12)

  • 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

Study Arms (2)

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

Interventions

Diaphragmatic BreathingBEHAVIORAL

Simple diaphragmatic breathing exercise

Diaphragmatic Breathing

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Keck Hospital of USC

Los Angeles, California, 90033, United States

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Linda J Rever, MD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda J Rever, MD

CONTACT

3234427400rever@usc.edu

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor of Anesthesiology

Study Record Dates

First Submitted

December 19, 2019

First Posted

April 7, 2020

Study Start

June 10, 2024

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

August 27, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)