Anesthesia and AnalgesiaNCT04336579
Diaphragmatic Breathing Exercises in Total Knee Arthroplasty Patients
An observational study of Anesthesia and Analgesia, run by University of Southern California at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Anesthesia and Analgesia
- What is being tested?
- Diaphragmatic Breathing
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2024to 1 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients (participants) undergoing total knee arthroplasty with a continuous peripheral nerve block catheter
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Keck Hospital of USC
Los Angeles, California, 90033
About this study
Official title: 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.
Read the 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).
- Conditions
- Anesthesia and Analgesia
- Being tested
- Diaphragmatic Breathing
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic BreathingBehavioural
Simple diaphragmatic breathing exercise
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Diaphragmatic Breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Level
Verbal Analog Pain Score - rate pain on 0-10 scale where 0=no pain, 10= worst possible pain
Measured: Prior to intervention
Opioid Usage (morphine equivalents)
Opioid Usage for pain
Measured: Prior to intervention
Anxiety Level
Verbal Analog Score -rate anxiety on 0-10 scale where 0= no anxiety, 10= worst possible anxiety
Measured: Prior to intervention
Pain Level
Verbal Analog Pain Score - rate pain on 0-10 scale where 0 =no pain, 10 = worst possible pain
Measured: 15 minutes after intervention
Opioid Usage (morphine equivalents)
Opioid Usage for pain
Measured: 15 minutes after intervention
Anxiety Level
Verbal Analog Score - rate anxiety on 0-10 scale where 0 =no anxiety, 10 = worst possible anxiety
Measured: 15 minutes after intervention
Pain Level
Verbal Analog Pain Score - rate pain on 0-10 scale where 0 =no pain, 10 = worst possible pain
Measured: 6 hours after intervention
Opioid Usage (morphine equivalents)
Opioid Usage for pain
Measured: 6 hours after intervention
Anxiety Level
Verbal Analog Score- rate anxiety on 0-10 scale where 0 =no anxiety, 10 = worst possible anxiety
Measured: 6 hours after intervention
Pain Level
Verbal Analog Pain Score - rate pain on 0-10 scale where 0 =no pain, 10 = worst possible pain
Measured: 1 day after intervention
Opioid Usage (morphine equivalents)
Opioid Usage for pain
Measured: 1 day after intervention
Anxiety Level
Verbal Analog Score - rate anxiety on 0-10 scale where 0 = no anxiety, 10 = worst possible pain
Measured: 1 day after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start10 Jun 2024
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia and AnalgesiaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Rever, University of Southern California
- Investigators
- Linda J Rever, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336579
- Sponsor's protocol ID
- HS-19-00223
- Status last verified
- Aug 2024
- First submitted
- 19 Dec 2019
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragmatic Breathing Exercises As An Analgesia Adjunct in Total Knee Arthroplasty Patients in the Perioperative Period
- ClinicalTrials.gov ID
- NCT04336579
- Acronym / sponsor ID
- HS-19-00223
- Conditions
- Anesthesia and Analgesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 7 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Retrospective review of patients (participants) with standard analgesia post total knee arthroplasty |
| Diaphragmatic Breathing | – | Behavioral: Diaphragmatic BreathingIntervention: Participants will perform diaphragmatic breathing exercises postoperatively as part of their multi-modal pain regimen. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients (participants) undergoing total knee arthroplasty with a continuous peripheral nerve block catheter
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaphragmatic BreathingSimple diaphragmatic breathing exercise | Behavioural | Diaphragmatic Breathing |
Primary outcome
Pain Level
Time frame: 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)
Time frame: Prior to intervention
Opioid Usage for pain
Anxiety Level
Time frame: Prior to intervention
Verbal Analog Score -rate anxiety on 0-10 scale where 0= no anxiety, 10= worst possible anxiety
Pain Level
Time frame: 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)
Time frame: 15 minutes after intervention
Opioid Usage for pain
Anxiety Level
Time frame: 15 minutes after intervention
Verbal Analog Score - rate anxiety on 0-10 scale where 0 =no anxiety, 10 = worst possible anxiety
Pain Level
Time frame: 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)
Time frame: 6 hours after intervention
Opioid Usage for pain
Anxiety Level
Time frame: 6 hours after intervention
Verbal Analog Score- rate anxiety on 0-10 scale where 0 =no anxiety, 10 = worst possible anxiety
Pain Level
Time frame: 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)
Time frame: 1 day after intervention
Opioid Usage for pain
Anxiety Level
Time frame: 1 day after intervention
Verbal Analog Score - rate anxiety on 0-10 scale where 0 = no anxiety, 10 = worst possible pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Individual participant dataSharing planned: No
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Pain Management
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda J Rever, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Analgesia, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linda J Rever, MD (3234427400, rever@usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Level (time frame: Prior to intervention). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.