Diaphragmatic Breathing Exercises in Total Knee Arthroplasty Patients

Anesthesia and Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04336579
• Other study ID #: HS-19-00223
• Status: Not yet recruiting
• Start date: May 1, 2020
• Est. completion date: February 1, 2021

Study information

• Verified date: April 2020
• Source: University of Southern California
• Contact: LInda J Rever, MD
• Phone: 3234094597
• Email: rever[@]usc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia and Analgesia
• Respiratory Aspiration

Intervention

Behavioral:
• Diaphragmatic Breathing
Simple diaphragmatic breathing exercise

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Outcome

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