Anesthesia, Opioid Use
Conditions
Keywords
Hip replacement, Opioid free, Perioperative period, Team work
Brief summary
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.
Interventions
BEHAVIORALGuided mindfulness exercises
Guided Meditation twice daily
OTHERSelf-administered aromatherapy
Self-administered aromatherapy every 6 hours and at bedtime
DRUGBaby aspirin
Baby aspirin 81mg: Twice daily for 6 weeks after surgery
DRUGTylenol/Acetaminophen
Tylenol/Acetaminophen 1000mg: Pre-operative one dose; Every 8 hours for three weeks after surgery
DRUGPregabalin
Pregabalin 25mg: Twice a day for two weeks before surgery; Pre-operative 25-100 mg; Twice a day for two weeks after surgery
DRUGPrednisone
Prednisone 5mg: Daily for three weeks after surgery
DRUGMeloxicam
Meloxicam 7.5mg: Twice a day, with food, for two weeks before surgery; Twice a day, with food, for two weeks after surgery
DRUGPrilosec
Prilosec 20mg: Daily for two weeks before surgery; Daily for for two weeks after surgery
DRUGTramadol
Rescue pain medicine Tramadol 50mg up to three times a day as needed will be provided for rescue pain
DRUGVoltaren
Voltaren 1% topical arthritis gel up to 4 times daily pre-operative only
DRUGZofran
Zofran 4 mg pre-operative
DRUGPepcid
Pepcid 20 mg pre-operative
DRUGReglan
Reglan 10 mg pre-operative
DRUGVersed
Versed 2 mg pre-operative
DRUGLidocaine
Lidocaine (preservative free) height based dosing for subarachnoid block intraoperatively
DRUGPropofol
Propofol 10-125 mcg/kg/min intraoperative
DRUGAncef
Ancef 2-3 gm weight-based dosing intraoperative
DRUGTranexamic Acid (TXA)
Tranexamic Acid (TXA) 2 gm intraoperative
DRUGDecadron
Decadron 10 mg intraoperative
DRUGBupivacaine hydrochloride
Local anaesthetic 0.5% bupivacaine hydrochloride intraoperative
DRUGToradol
Toradol nonsteroidal anti-inflammatory drug max 30 mg intraoperative
Sponsors
Emory University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Matched Prospective Case with Retrospective Control Study and Staff Survey
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Intervention group: * Prospective study participants undergoing unilateral total hip replacement surgery between the months of February through May, 2021 Inclusion Criteria Control: * 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 Inclusion Criteria Professional Staff: * All staff that participate in the implementation of the opioid free surgical protocol.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Post-operative Opioid Requirements With Non-opioid Drug Regimen | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nebraska Interprofessional Education Attitude Scale (NIPEAS) Score for Professional Staff Arm | 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) | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Prospective Cases Undergoing Non-opioid Drug Regimen Study participants receiving a perioperative non-opioid drug regimen when undergoing unilateral total hip replacement surgery. | 7 |
| 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. | 0 |
| 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. | 50 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 | 13 |
Baseline characteristics
| Characteristic | Prospective Cases Undergoing Non-opioid Drug Regimen | Total | Professional Staff |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | — |
| Age, Categorical >=65 years | 5 Participants | 5 Participants | — |
| Age, Categorical Between 18 and 65 years | 2 Participants | 2 Participants | — |
| Age, Continuous | 70 years STANDARD_DEVIATION 12 | 70 years STANDARD_DEVIATION 12 | — |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 6 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 17 Participants | 17 Participants |
| Race (NIH/OMB) White | 7 Participants | 29 Participants | 22 Participants |
| Region of Enrollment United States | 7 participants | 57 participants | 50 participants |
| Sex/Gender, Customized Female | 7 Participants | 32 Participants | 25 Participants |
| Sex/Gender, Customized Male | 0 Participants | 9 Participants | 9 Participants |
| Sex/Gender, Customized Other | 0 Participants | 3 Participants | 3 Participants |
| Sex/Gender, Customized Unknown or not reported | 0 Participants | 13 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 37 |
| other Total, other adverse events | 0 / 7 | 0 / 37 |
| serious Total, serious adverse events | 0 / 7 | 0 / 37 |
Outcome results
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.
Time frame: Up to 5 weeks
Population: This analysis includes participants who completed the study and required post-operative opioid medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prospective Cases Undergoing Non-opioid Drug Regimen | Total Post-operative Opioid Requirements With Non-opioid Drug Regimen | 400 milligrams | Standard Deviation 0 |
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.
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)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prospective Cases Undergoing Non-opioid Drug Regimen | Nebraska Interprofessional Education Attitude Scale (NIPEAS) Score for Professional Staff Arm | Baseline | 4.35 score on a scale | Standard Deviation 0.39 |