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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.
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The objective of this study is to pilot an opioid free anesthetic protocol for patients undergoing total hip replacement.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective cases undergoing non-opioid drug regimen | Experimental | Prospective 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guided mindfulness exercises | Behavioral | Guided Meditation twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria Intervention group:
Inclusion Criteria Control:
Inclusion Criteria Professional Staff:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wiltse Nicely, PhD, CRNA | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Orthopaedic and Spine Hospital | Atlanta | Georgia | 30322 | United States |
Individual participant data that underlie the results reported in peer reviewed publication(s) will be shared after de-identification.
Data will be available for sharing beginning 6 months and ending 36 months following article publication.
Data will be available for sharing with investigators whose proposed use of the data have been approved by an independent review committee identified for that purpose. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in Emory University's data warehouse but without investigator support other than deposited metadata. Information regarding the Emory Dataverse can be found at: http://sco.library.emory.edu/dataverse/index.html
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Participants were recruited from the Emory Orthopaedics & Spine Center in Atlanta, Georgia, USA. Participant enrollment began May 17, 2021 and the final follow-up assessment occurred December 27, 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Prospective Cases Undergoing Non-opioid Drug Regimen | Study participants receiving a perioperative non-opioid drug regimen when undergoing unilateral total hip replacement surgery. The non-opioid drug regiment includes the following: Guided mindfulness meditation twice daily; Self-administered aromatherapy every 6 hours and at bedtime; Baby aspirin (81mg) twice daily for 6 weeks post surgery; Tylenol/Acetaminophen (1000mg) one pre-operative dose then every 8 hours for three weeks after surgery; Pregabalin twice a day for 2 weeks before surgery and twice a day for 2 weeks after surgery; Prednisone (5mg) Daily for 3 weeks after surgery; Meloxicam (7.5mg) twice a day for 2 weeks before surgery and twice a day, for 2 weeks after surgery; Prilosec (20mg) Daily for 2 weeks before surgery and 2 weeks after surgery; Rescue pain medicine Tramadol (50mg) up to 3 times a day as needed; Voltaren 1% topical arthritis gel up to 4 times daily pre-operative only; Zofran 4 mg pre-operative; Pepcid 20 mg pre-operative; Reglan 10 mg pre-operative; Versed 2 mg pre-operative; Lidocaine (preservative free) height based dosing for subarachnoid block intraoperatively; Propofol 10-125 mcg/kg/min intraoperative; Ancef 2-3 gm weight-based dosing intraoperative; Tranexamic Acid (TXA) 2 gm intraoperative; Decadron 10 mg intraoperative; Local anaesthetic 0.5% bupivacaine hydrochloride intraoperative; Toradol nonsteroidal anti-inflammatory drug max 30 mg intraoperative |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 8, 2021 |
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Matched Prospective Case with Retrospective Control Study and Staff Survey
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| Self-administered aromatherapy | Other | Self-administered aromatherapy every 6 hours and at bedtime |
|
| Baby aspirin | Drug | Baby aspirin 81mg: Twice daily for 6 weeks after surgery |
|
| Tylenol/Acetaminophen | Drug | Tylenol/Acetaminophen 1000mg: Pre-operative one dose; Every 8 hours for three weeks after surgery |
|
| Pregabalin | Drug | Pregabalin 25mg: Twice a day for two weeks before surgery; Pre-operative 25-100 mg; Twice a day for two weeks after surgery |
|
| Prednisone | Drug | Prednisone 5mg: Daily for three weeks after surgery |
|
| Meloxicam | Drug | Meloxicam 7.5mg: Twice a day, with food, for two weeks before surgery; Twice a day, with food, for two weeks after surgery |
|
| Prilosec | Drug | Prilosec 20mg: Daily for two weeks before surgery; Daily for for two weeks after surgery |
|
| Tramadol | Drug | Rescue pain medicine Tramadol 50mg up to three times a day as needed will be provided for rescue pain |
|
| Voltaren | Drug | Voltaren 1% topical arthritis gel up to 4 times daily pre-operative only |
|
| Zofran | Drug | Zofran 4 mg pre-operative |
|
| Pepcid | Drug | Pepcid 20 mg pre-operative |
|
| Reglan | Drug | Reglan 10 mg pre-operative |
|
| Versed | Drug | Versed 2 mg pre-operative |
|
| Lidocaine | Drug | Lidocaine (preservative free) height based dosing for subarachnoid block intraoperatively |
|
| Propofol | Drug | Propofol 10-125 mcg/kg/min intraoperative |
|
| Ancef | Drug | Ancef 2-3 gm weight-based dosing intraoperative |
|
| Tranexamic Acid (TXA) | Drug | Tranexamic Acid (TXA) 2 gm intraoperative |
|
| Decadron | Drug | Decadron 10 mg intraoperative |
|
| Bupivacaine hydrochloride | Drug | Local anaesthetic 0.5% bupivacaine hydrochloride intraoperative |
|
| Toradol | Drug | Toradol nonsteroidal anti-inflammatory drug max 30 mg intraoperative |
|
| 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) |
| FG001 | Retrospective Control Underwent Opioid Drug Regimen | A group of retrospective controls that underwent unilateral total hip replacement surgery and used opioid drug regimen perioperatively was initially intended to be created from medical records of patients who had received this surgery in the time prior to this study started, upon conclusion of data collection for the prospective cases. This study did not complete as anticipated and the retrospective control group was not created prior to the early termination of the study. |
| FG002 | Professional Staff | Professional staff who participated in the implementation of the opioid free surgical protocol completed surveys seeking their opinion about interprofessional teamwork and communication. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline information is not available for the retrospective control group as the study was terminated prior to creating this study arm. Only minimal, optional, demographic information was collected from professional staff to maintain anonymity among respondents and to ease their burden of study related activities.
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| ID | Title | Description |
|---|---|---|
| BG000 | Prospective Cases Undergoing Non-opioid Drug Regimen | Study participants receiving a perioperative non-opioid drug regimen when undergoing unilateral total hip replacement surgery. |
| BG001 | Retrospective Control Underwent Opioid Drug Regimen | A group of retrospective controls that underwent unilateral total hip replacement surgery and used opioid drug regimen perioperatively was initially intended to be created from medical records of patients who had received this surgery in the time prior to this study started, upon conclusion of data collection for the prospective cases. This study did not complete as anticipated and the retrospective control group was not created prior to the early termination of the study. |
| BG002 | Professional Staff | Professional staff who participated in the implementation of the opioid free surgical protocol completed surveys seeking their opinion about interprofessional teamwork and communication. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age was not collected for the professional staff to ensure that survey responses were anonymous. | Count of Participants | Participants |
| ||||||||||
| Age, Continuous | Age was not collected for the professional staff to ensure that survey responses were anonymous. | Mean | Standard Deviation | years |
| |||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
| |||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | This analysis includes participants who completed the study and required post-operative opioid medication. | Posted | Mean | Standard Deviation | milligrams | Up to 5 weeks |
|
|
| |||||||||||||||||||||||||
| Secondary | 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. | The baseline survey was provided to all perioperative suite professional staff who gave their consent to participate in the study, however, 13 did not complete the survey. The follow-up surveys were to be completed once the full protocol had been implemented on all 60 anticipated patient participants. As the trial was terminated prior to enrolling 60 participants, the follow-up NIPEAS scale scores were not collected. | Posted | Mean | Standard Deviation | score on a scale | 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) |
|
Information on adverse events was collected beginning at the time consent to participate in the study was given, up 5 weeks post-surgery for patient participants, or upon completion of the baseline survey for professional staff participants.
Information on adverse events is not available for the retrospective control group as the study was terminated prior to creating this study arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prospective Cases Undergoing Non-opioid Drug Regimen | Study participants receiving a perioperative non-opioid drug regimen when undergoing unilateral total hip replacement surgery. | 0 | 7 | 0 | 7 | 0 | 7 |
| EG001 | Professional Staff | Professional staff who participated in the implementation of the opioid free surgical protocol completed surveys seeking their opinion about interprofessional teamwork and communication. | 0 | 37 | 0 | 37 | 0 | 37 |
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This study aimed to enroll a total of 170 participants. Due to staffing issues and the coronavirus disease 2019 (COVID-19) pandemic, this trial was terminated early and therefore the retrospective data was not collected.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelly Wiltse Nicely, MD | Emory University | 404-727-6946 | kelly.wiltse.nicely@emory.edu |
| Mar 31, 2023 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D000069583 | Pregabalin |
| D011241 | Prednisone |
| D000077239 | Meloxicam |
| D009853 | Omeprazole |
| D014147 | Tramadol |
| D004008 | Diclofenac |
| D017294 | Ondansetron |
| D015738 | Famotidine |
| D008787 | Metoclopramide |
| D008874 | Midazolam |
| D008012 | Lidocaine |
| D015742 | Propofol |
| D002437 | Cefazolin |
| D014148 | Tranexamic Acid |
| D002123 | Calcium Dobesilate |
| D002045 | Bupivacaine |
| D020911 | Ketorolac Tromethamine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D008055 | Lipids |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D007093 | Imidazoles |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D001549 | Benzamides |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D002723 | Chlorobenzoates |
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D003509 | Cyclohexanecarboxylic Acids |
| D001557 | Benzenesulfonates |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D007213 | Indomethacin |
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|
|
|
| Male |
|
|
| Other |
|
|
| Unknown or not reported |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|