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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04766996
Other study ID # STUDY00002021
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date May 17, 2021
Est. completion date December 27, 2021

Study information

Verified date June 2023
Source Emory University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to pilot an opioid free anesthetic protocol for patients undergoing total hip replacement.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 57
Est. completion date December 27, 2021
Est. primary completion date December 27, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Guided mindfulness exercises
Guided Meditation twice daily
Other:
Self-administered aromatherapy
Self-administered aromatherapy every 6 hours and at bedtime
Drug:
Baby aspirin
Baby aspirin 81mg: Twice daily for 6 weeks after surgery
Tylenol/Acetaminophen
Tylenol/Acetaminophen 1000mg: Pre-operative one dose; Every 8 hours for three weeks after surgery
Pregabalin
Pregabalin 25mg: Twice a day for two weeks before surgery; Pre-operative 25-100 mg; Twice a day for two weeks after surgery
Prednisone
Prednisone 5mg: Daily for three weeks after surgery
Meloxicam
Meloxicam 7.5mg: Twice a day, with food, for two weeks before surgery; Twice a day, with food, for two weeks after surgery
Prilosec
Prilosec 20mg: Daily for two weeks before surgery; Daily for for two weeks after surgery
Tramadol
Rescue pain medicine Tramadol 50mg up to three times a day as needed will be provided for rescue pain
Voltaren
Voltaren 1% topical arthritis gel up to 4 times daily pre-operative only
Zofran
Zofran 4 mg pre-operative
Pepcid
Pepcid 20 mg pre-operative
Reglan
Reglan 10 mg pre-operative
Versed
Versed 2 mg pre-operative
Lidocaine
Lidocaine (preservative free) height based dosing for subarachnoid block intraoperatively
Propofol
Propofol 10-125 mcg/kg/min intraoperative
Ancef
Ancef 2-3 gm weight-based dosing intraoperative
Tranexamic Acid (TXA)
Tranexamic Acid (TXA) 2 gm intraoperative
Decadron
Decadron 10 mg intraoperative
Bupivacaine hydrochloride
Local anaesthetic 0.5% bupivacaine hydrochloride intraoperative
Toradol
Toradol nonsteroidal anti-inflammatory drug max 30 mg intraoperative

Locations

Country Name City State
United States Emory University Orthopaedic and Spine Hospital Atlanta Georgia

Sponsors (1)

Lead Sponsor Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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. 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. 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)
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