AnesthesiaPhase 4NCT04766996
PROUD Study - Preventing Opioid Use Disorders
A Phase 4 study testing Guided mindfulness exercises, Self-administered aromatherapy and Baby aspirin in people with Anesthesia and Opioid Use, run by Emory University at 1 site in United States.
Trial summary
The objective of this study is to pilot an opioid free anesthetic protocol for patients undergoing total hip replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Opioid Use
- What is being tested?
- Guided mindfulness exercises, Self-administered aromatherapy and Baby aspirin
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2021to 27 Dec 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prospective study participants undergoing unilateral total hip replacement surgery between the months of February through May, 2021
- Retrospective controls selected from the Emory Healthcare System Clinical Data Warehouse that underwent unilateral total hip replacement surgery between the months of February through May, 2020
- All staff that participate in the implementation of the opioid free surgical protocol.
Who cannot join
- Participants that do not speak English will not be eligible for participation in the study.
- Individuals less than 18 years of age will not be included for participation in the study.
- Individuals with cognitive impairment or the inability to provide informed consent will not be included in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University Orthopaedic and Spine Hospital
Atlanta, Georgia, 30322
About this study
The objective of this study is to pilot an opioid free anesthetic protocol for patients undergoing total hip replacement.
Read the detailed description
The objective of this study is to pilot an opioid free anesthetic protocol for patients undergoing total hip replacement. The study team identified alternative pharmacologic methods to block pain pathways to reduce or even eliminate the need for opioids in the intra- and postoperative periods, with the goal of decreasing or eliminating exposure to opioids. A secondary objective is to assess two core competencies for interprofessional collaborative practice (Interprofessional Communication and Teams; and Teamwork) within the interprofessional care team implementing the opioid free protocol.
- Conditions
- Anesthesia, Opioid Use
- Being tested
- Guided mindfulness exercises, Self-administered aromatherapy, Baby aspirin, Tylenol/Acetaminophen, Pregabalin
- Keywords
- Hip replacement, Opioid free, Perioperative period, Team work
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided mindfulness exercisesBehavioural
Guided Meditation twice daily
Self-administered aromatherapyOther
Self-administered aromatherapy every 6 hours and at bedtime
Baby aspirinDrug
Baby aspirin 81mg: Twice daily for 6 weeks after surgery
Tylenol/AcetaminophenDrug
Tylenol/Acetaminophen 1000mg: Pre-operative one dose; Every 8 hours for three weeks after surgery
PregabalinDrug
Pregabalin 25mg:
Twice a day for two weeks before surgery; Pre-operative 25-100 mg; Twice a day for two weeks after surgery
PrednisoneDrug
Prednisone 5mg: Daily for three weeks after surgery
MeloxicamDrug
Meloxicam 7.5mg:
Twice a day, with food, for two weeks before surgery; Twice a day, with food, for two weeks after surgery
PrilosecDrug
Prilosec 20mg:
Daily for two weeks before surgery; Daily for for two weeks after surgery
TramadolDrug
Rescue pain medicine Tramadol 50mg up to three times a day as needed will be provided for rescue pain
VoltarenDrug
Voltaren 1% topical arthritis gel up to 4 times daily pre-operative only
ZofranDrug
Zofran 4 mg pre-operative
PepcidDrug
Pepcid 20 mg pre-operative
ReglanDrug
Reglan 10 mg pre-operative
VersedDrug
Versed 2 mg pre-operative
LidocaineDrug
Lidocaine (preservative free) height based dosing for subarachnoid block intraoperatively
PropofolDrug
Propofol 10-125 mcg/kg/min intraoperative
AncefDrug
Ancef 2-3 gm weight-based dosing intraoperative
Tranexamic Acid (TXA)Drug
Tranexamic Acid (TXA) 2 gm intraoperative
DecadronDrug
Decadron 10 mg intraoperative
Bupivacaine hydrochlorideDrug
Local anaesthetic 0.5% bupivacaine hydrochloride intraoperative
ToradolDrug
Toradol nonsteroidal anti-inflammatory drug max 30 mg intraoperative
| Study group | Role | What they receive |
|---|---|---|
| Prospective cases undergoing non-opioid drug regimen | Experimental | Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively Receives: Behavioral: Guided mindfulness exercises; Other: Self-administered aromatherapy; Drug: Baby aspirin; Drug: Tylenol/Acetaminophen; Drug: Pregabalin; Drug: Prednisone; Drug: Meloxicam; Drug: Prilosec; Drug: Tramadol; Drug: Voltaren; Drug: Zofran; Drug: Pepcid; Drug: Reglan; Drug: Versed; Drug: Lidocaine; Drug: Propofol; Drug: Ancef; Drug: Tranexamic Acid (TXA); Drug: Decadron; Drug: Bupivacaine hydrochloride; Drug: Toradol |
| Retrospective control underwent opioid drug regimen | No intervention | Retrospective controls that underwent unilateral total hip replacement surgery and used opioid drug regimen perioperatively |
| Professional Staff | No intervention | Staff that participate in the implementation of the opioid free surgical protocol will be completing team assessment surveys seeking their opinion about interprofessional teamwork and communication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Post-operative Opioid Requirements With Non-opioid Drug Regimen
Total post-operative opioid requirements (opioid dose) were calculated for participants receiving the non-opioid drug regimen, among participants who required post-operative opioid medication.
Measured: Up to 5 weeks
Secondary outcomes (1)
Nebraska Interprofessional Education Attitude Scale (NIPEAS) Score for Professional Staff Arm
The Nebraska Interprofessional Education Attitude Scale (NIPEAS) was developed to measure the attitudes of pre-clinical learners to practicing health professionals. The NIPEAS is a 19-item questionnaire assessing attitudes related to interprofessional collaboration. Responses were given using a 5-point Likert scale where 1 = Strongly Disagree to 5 = Strongly Agree. The total score is the average of the average scores for each item and ranges from 1 to 5. A higher total score indicates increased positive perceptions toward interprofessional collaboration.
Measured: Prior to protocol implementation (baseline), halfway through the recruitment period (2 months) and after the last participant has been discharged from the hospital (4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start17 May 2021
- Primary completion27 Dec 2021
- Study completion27 Dec 2021
Why it stopped: Loss of surgery team member deemed the study procedures impossible to achieve, and no replacement could be found in a timely manner to complete trial as initially planned.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Matched Prospective Case with Retrospective Control Study and Staff Survey
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelly Wiltse Nicely, Emory University
- Investigators
- Wiltse Nicely, PhD, CRNA, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766996
- Sponsor's protocol ID
- STUDY00002021
- Status last verified
- Jun 2023
- First submitted
- 19 Feb 2021
- Last updated
- 22 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in peer reviewed publication(s) will be shared after de-identification.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROUD Study - Preventing Opioid Use Disorders
- ClinicalTrials.gov ID
- NCT04766996
- Acronym / sponsor ID
- STUDY00002021
- Conditions
- Anesthesia, Opioid Use
- Keywords
- Hip replacement, Opioid free, Perioperative period, Team work
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Loss of surgery team member deemed the study procedures impossible to achieve, and no replacement could be found in a timely manner to complete trial as initially planned.
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 17 May 2021 (actual)
- Primary completion
- 27 Dec 2021 (actual)
- Study completion
- 27 Dec 2021 (actual)
- First posted
- 23 Feb 2021 (actual)
- Results
- Posted 22 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to pilot an opioid free anesthetic protocol for patients undergoing total hip replacement.
Detailed description
The objective of this study is to pilot an opioid free anesthetic protocol for patients undergoing total hip replacement. The study team identified alternative pharmacologic methods to block pain pathways to reduce or even eliminate the need for opioids in the intra- and postoperative periods, with the goal of decreasing or eliminating exposure to opioids. A secondary objective is to assess two core competencies for interprofessional collaborative practice (Interprofessional Communication and Teams; and Teamwork) within the interprofessional care team implementing the opioid free protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Matched Prospective Case with Retrospective Control Study and Staff Survey
| Arm | Type | Receives |
|---|---|---|
| Prospective cases undergoing non-opioid drug regimen | Experimental | Behavioral: Guided mindfulness exercises, Other: Self-administered aromatherapy, Drug: Baby aspirin, Drug: Tylenol/Acetaminophen, Drug: Pregabalin, Drug: Prednisone, Drug: Meloxicam, Drug: Prilosec, Drug: Tramadol, Drug: Voltaren, Drug: Zofran, Drug: Pepcid, Drug: Reglan, Drug: Versed, Drug: Lidocaine, Drug: Propofol, Drug: Ancef, Drug: Tranexamic Acid (TXA), Drug: Decadron, Drug: Bupivacaine hydrochloride, Drug: ToradolProspective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively |
| Retrospective control underwent opioid drug regimen | No intervention | –Retrospective controls that underwent unilateral total hip replacement surgery and used opioid drug regimen perioperatively |
| Professional Staff | No intervention | –Staff that participate in the implementation of the opioid free surgical protocol will be completing team assessment surveys seeking their opinion about interprofessional teamwork and communication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Prospective study participants undergoing unilateral total hip replacement surgery between the months of February through May, 2021
- Retrospective controls selected from the Emory Healthcare System Clinical Data Warehouse that underwent unilateral total hip replacement surgery between the months of February through May, 2020
- All staff that participate in the implementation of the opioid free surgical protocol.
Key exclusion criteria (3 listed)
- Participants that do not speak English will not be eligible for participation in the study.
- Individuals less than 18 years of age will not be included for participation in the study.
- Individuals with cognitive impairment or the inability to provide informed consent will not be included in the study.
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 |
|---|---|---|
| Guided mindfulness exercisesGuided Meditation twice daily | Behavioural | Prospective cases undergoing non-opioid drug regimen |
| Self-administered aromatherapySelf-administered aromatherapy every 6 hours and at bedtime | Other | Prospective cases undergoing non-opioid drug regimen |
| Baby aspirinBaby aspirin 81mg: Twice daily for 6 weeks after surgery | Drug | Prospective cases undergoing non-opioid drug regimen |
| Tylenol/AcetaminophenTylenol/Acetaminophen 1000mg: Pre-operative one dose; Every 8 hours for three weeks after surgery | Drug | Prospective cases undergoing non-opioid drug regimen |
| PregabalinPregabalin 25mg: Twice a day for two weeks before surgery; Pre-operative 25-100 mg; Twice a day for two weeks after surgery | Drug | Prospective cases undergoing non-opioid drug regimen |
| PrednisonePrednisone 5mg: Daily for three weeks after surgery | Drug | Prospective cases undergoing non-opioid drug regimen |
| MeloxicamMeloxicam 7.5mg: Twice a day, with food, for two weeks before surgery; Twice a day, with food, for two weeks after surgery | Drug | Prospective cases undergoing non-opioid drug regimen |
| PrilosecPrilosec 20mg: Daily for two weeks before surgery; Daily for for two weeks after surgery | Drug | Prospective cases undergoing non-opioid drug regimen |
| TramadolRescue pain medicine Tramadol 50mg up to three times a day as needed will be provided for rescue pain | Drug | Prospective cases undergoing non-opioid drug regimen |
| VoltarenVoltaren 1% topical arthritis gel up to 4 times daily pre-operative only | Drug | Prospective cases undergoing non-opioid drug regimen |
| ZofranZofran 4 mg pre-operative | Drug | Prospective cases undergoing non-opioid drug regimen |
| PepcidPepcid 20 mg pre-operative | Drug | Prospective cases undergoing non-opioid drug regimen |
| ReglanReglan 10 mg pre-operative | Drug | Prospective cases undergoing non-opioid drug regimen |
| VersedVersed 2 mg pre-operative | Drug | Prospective cases undergoing non-opioid drug regimen |
| LidocaineLidocaine (preservative free) height based dosing for subarachnoid block intraoperatively | Drug | Prospective cases undergoing non-opioid drug regimen |
| PropofolPropofol 10-125 mcg/kg/min intraoperative | Drug | Prospective cases undergoing non-opioid drug regimen |
| AncefAncef 2-3 gm weight-based dosing intraoperative | Drug | Prospective cases undergoing non-opioid drug regimen |
| Tranexamic Acid (TXA)Tranexamic Acid (TXA) 2 gm intraoperative | Drug | Prospective cases undergoing non-opioid drug regimen |
| DecadronDecadron 10 mg intraoperative | Drug | Prospective cases undergoing non-opioid drug regimen |
| Bupivacaine hydrochlorideLocal anaesthetic 0.5% bupivacaine hydrochloride intraoperative | Drug | Prospective cases undergoing non-opioid drug regimen |
| ToradolToradol nonsteroidal anti-inflammatory drug max 30 mg intraoperative | Drug | Prospective cases undergoing non-opioid drug regimen |
Primary outcome
Total Post-operative Opioid Requirements With Non-opioid Drug Regimen
Time frame: Up to 5 weeks
Total post-operative opioid requirements (opioid dose) were calculated for participants receiving the non-opioid drug regimen, among participants who required post-operative opioid medication.
1 secondary outcome
Nebraska Interprofessional Education Attitude Scale (NIPEAS) Score for Professional Staff Arm
Time frame: Prior to protocol implementation (baseline), halfway through the recruitment period (2 months) and after the last participant has been discharged from the hospital (4 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in peer reviewed publication(s) will be shared after de-identification.
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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.
Wiltse Nicely, PhD, CRNA principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Guided mindfulness exercises, Self-administered aromatherapy and Baby aspirin in people with Anesthesia and Opioid Use, run by Emory University 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 3 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: stopped early, as of the sponsor's last update on 22 Jun 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Post-operative Opioid Requirements With Non-opioid Drug Regimen (time frame: Up to 5 weeks). 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 22 Jun 2023.