Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06507345
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-04
Brief Title:
Postoperative Analgesia Intervention With Non-opioid Alternatives PAIN-Alt Trial - Breast Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparative Effectiveness of Opioid Versus Opioid-free Post-discharge Analgesia After Outpatient Breast Surgery A Protocol for a Randomized Controlled Trial PAIN-Alt Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAIN-Alt
Brief Summary:
North America is experiencing a crisis of opioid use and abuse partially caused by excessive prescribing by doctors People often receive their first opioid prescription for pain treatment after outpatient breast surgery ie surgery to remove all or parts of the breasts where patients leave the hospital the same day Many patients misuse these drugs and become addicted Additionally many of the opioid pills prescribed to patients are left unused and may be misused by family members friends or other community members To prevent this problem surgeons can avoid prescribing opioids by prioritizing opioid-free analgesia ie pain treatment using only non-opioid interventions Prescribing only non-opioid pain medications after surgery is very common in many countries outside of North America however few studies have assessed whether opioid-free analgesia is as effective as opioid analgesia after breast surgery Therefore the main question driving this study is For patients who undergo outpatient breast surgery is pain treatment without opioids as good as pain treatment with opioids
The proposed trial will compare two groups of patients one group will receive opioids to treat pain after surgery while the other group will receive only non-opioid medications The impact of these different medication strategies will be measured on pain intensity pain interference with daily activities medication side effects and other outcomes An expert team of scientists surgeons pain specialists nurses and patients has been assembled to maximize the success of this study The results will provide important information to guide surgeons decisions to prescribe or not to prescribe opioids If opioid-free analgesia is found to be effective doctors may be able to substantially reduce opioid prescribing after breast surgery and prevent more people from misusing opioids
The proposed trial will compare two groups of patients one group will receive opioids to treat pain after surgery while the other group will receive only non-opioid medications The impact of these different medication strategies will be measured on pain intensity pain interference with daily activities medication side effects and other outcomes An expert team of scientists surgeons pain specialists nurses and patients has been assembled to maximize the success of this study The results will provide important information to guide surgeons decisions to prescribe or not to prescribe opioids If opioid-free analgesia is found to be effective doctors may be able to substantially reduce opioid prescribing after breast surgery and prevent more people from misusing opioids
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None