Patient Education and Use of Post Operative Pain Medication in Ambulatory Hand Surgery: a Randomized Controlled Trial
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|ClinicalTrials.gov Identifier: NCT03219177|
Recruitment Status : Recruiting
First Posted : July 17, 2017
Last Update Posted : February 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ambulatory Hand Surgery||Behavioral: Patient education regarding indications for opioid use and side effects of opioid use after hand surgery Other: Standard of care post-operative counseling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Patient Education and Use of Postoperative Pain Medication in Ambulatory Hand Surgery: a Randomized Controlled Trial|
|Actual Study Start Date :||June 15, 2017|
|Estimated Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||December 1, 2019|
|Experimental: Patient education group||
Behavioral: Patient education regarding indications for opioid use and side effects of opioid use after hand surgery
Patients in the active education group will be given information pre-operatively on the current opioid epidemic, alternative pain management strategies that should be tried before proceeding to prescription opioid use, appropriate indications for opioid use, and side effects of opioids.This information will be reinforced by the research coordinator and nursing staff in the post-anesthesia care unit.
|Active Comparator: Control- Standard of care counseling||
Other: Standard of care post-operative counseling
Patients will receive standard of care post-operative counseling. They will not be given pre or post-operative opioid education.
- Number of prescription opioids used postoperatively [ Time Frame: Within 14 days of surgery ]
- Patient satisfaction [ Time Frame: Post-op day 3, 8, and 15 ]This will be measured on a Likert scale, as used in most orthopedics research.
- Pain level [ Time Frame: Post-op day 3, 8, 15 ]Numeric Rating Scale pain scores
- Surgical factors [ Time Frame: Recorded on day of surgery ]Type of surgery, length of surgery, type and amount of anesthesia
- Pain Catastrophization Score [ Time Frame: Measured pre-operatively ]This validated scale is one of the most widely used instruments to evaluate catastrophic thinking related to pain. It specifically evaluates patients' feelings of helplessness and frequency of rumination on and magnification of pain.
- Mindfulness Attention Awareness Scale Score [ Time Frame: Measured pre-operatively ]This validated scale assesses dispositional mindfulness and has been shown to tap a unique quality of consciousness that is associated with self-regulation and well-being constructs.
- Adverse reactions to pain medication [ Time Frame: Post-op day 3, 8, 15 ]Side effects of opioid and non-opioid medications will be assessed
- Prescriptions filled and refilled [ Time Frame: Post-op day 3, 8, 15 ]We will assess whether patients both initially filled and re-filled their opioid prescriptions
- Alternative analgesia used [ Time Frame: Post-op day 3, 8, 15 ]We will identify if patients use any alternative pain management strategies (i.e., elevation, icing, breathing exercises, mediation, etc.)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03219177
|Contact: Hayley Sacks, BAfirstname.lastname@example.org|
|United States, New York|
|Hospital for Special Surgery||Recruiting|
|New York, New York, United States, 10021|
|Contact: Hayley Sacks, BA 212-606-1440 email@example.com|
|Sub-Investigator: Jeffrey Stepan, MD|
|Principal Investigator: Duretti Fufa, MD|