Recruiting

Diaphragmatic Breathing

Sponsor:

University of Southern California

Code:

NCT04336579

Conditions

Anesthesia and Analgesia

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Diaphragmatic Breathing

Study Details

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.

Conditions

Anesthesia and Analgesia

Study ID

NCT04336579

Start date

Jun 10, 2024

Status verified date

Aug, 2024

Completion date

Oct 1, 2024

Anticipated

Primary completion date

Oct 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Diaphragmatic Breathing

Simple diaphragmatic breathing exercise

Primary outcome measure

  • 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 ]
  • Opioid Usage (morphine equivalents) [ Time Frame: 1 day after intervention ]
  • Anxiety Level [ Time Frame: 1 day after intervention ]

Central Contacts and Locations

Central contacts

Linda J Rever, MD

3234427400rever@usc.edu

Locations

Keck Hospital of USC

Recruiting

Los Angeles, California, United States, 90033

More Information

Sponsor

University of Southern California

Last update posted

Aug 27, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Southern California on 2024-08-27.