Ignite Creation Date:
2024-05-06 @ 4:08 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04885231
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-29
First Post:
2021-05-02
Brief Title:
Impact of Counseling and Education on Opioid Consumption After ACL Reconstruction
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Impact of Counseling and Education on Opioid Consumption After Anterior Cruciate Ligament Reconstruction A Randomized Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARE
Brief Summary:
Research question Does an opioid limiting pain management counseling and education program result in decreased opioid consumption and improved pain control compared to traditional pain management programs after anterior cruciate ligament reconstruction ACLR surgery
At many institutions the current standard of care is to instruct patients to take opioid pain medicine as needed when in severe pain to stay ahead of the pain This study is investigating whether modifying the instructions to take opioid pain medications only if in unbearable pain will have an effect on 1 reducing opioid consumption and 2 improving pain levels
Adults who are undergoing an ACLR surgery will be invited to participate in the study and be randomly assigned to one of the two pain management programs All patients will receive a comprehensive multi-modality pain management treatments and medications Patients in both groups will receive the same type and amount of all postoperative medications The only difference will be in the instructions about when to take the opioid medications
The patients will then be sent an electronic survey twice per day for 2 weeks about their pain levels and number of opioid pills taken
At many institutions the current standard of care is to instruct patients to take opioid pain medicine as needed when in severe pain to stay ahead of the pain This study is investigating whether modifying the instructions to take opioid pain medications only if in unbearable pain will have an effect on 1 reducing opioid consumption and 2 improving pain levels
Adults who are undergoing an ACLR surgery will be invited to participate in the study and be randomly assigned to one of the two pain management programs All patients will receive a comprehensive multi-modality pain management treatments and medications Patients in both groups will receive the same type and amount of all postoperative medications The only difference will be in the instructions about when to take the opioid medications
The patients will then be sent an electronic survey twice per day for 2 weeks about their pain levels and number of opioid pills taken
Detailed Description:
Prescription narcotic pain medications opioids were responsible for roughly 17000 deaths in 2016 in the United States Orthopedic surgeons were responsible for prescribing the third highest percentage of opioids among physicians in 2009 In recent years orthopaedic surgeons have used many different types of non-opioid pain medications and methods to reduce patients opioid after surgery Opioid dependence can manifest from prescription use especially in patients who have never used opioids before
The purpose of this study is to research the effect of different pain management education programs on pain control and opioid use after an anterior cruciate ligament reconstruction ACLR surgery Specifically does education directed at avoiding opioids unless in unbearable pain have any effect on reducing pain levels and opioid consumption in the early postoperative period compared to traditional pain management education
Patients who agree to participate in this study will be assigned at random to two opioid education programs after ACLR All patients will be given peri-operative pain management counseling and education Patients in the experimental group will be instructed to avoid opioids unless in unbearable pain Patients in the control group will be instructed to take opioid medication as needed for severe pain to stay ahead of the pain Participants in both groups will be prescribed the exact same type and amount of postoperative medications
Surveys will be sent electronically to patients twice per day for 2 weeks to monitor pain levels and the amount of opioid consumption Also patients will be asked to complete demographic and patient-reported outcome questionnaires after surgery Patients will be involved in the study for 3 months
The purpose of this study is to research the effect of different pain management education programs on pain control and opioid use after an anterior cruciate ligament reconstruction ACLR surgery Specifically does education directed at avoiding opioids unless in unbearable pain have any effect on reducing pain levels and opioid consumption in the early postoperative period compared to traditional pain management education
Patients who agree to participate in this study will be assigned at random to two opioid education programs after ACLR All patients will be given peri-operative pain management counseling and education Patients in the experimental group will be instructed to avoid opioids unless in unbearable pain Patients in the control group will be instructed to take opioid medication as needed for severe pain to stay ahead of the pain Participants in both groups will be prescribed the exact same type and amount of postoperative medications
Surveys will be sent electronically to patients twice per day for 2 weeks to monitor pain levels and the amount of opioid consumption Also patients will be asked to complete demographic and patient-reported outcome questionnaires after surgery Patients will be involved in the study for 3 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None