Distal Radius Fracture Clinical Trial
Official title:
Preop Education and Opioid Use After Hand and Wrist Fracture ORIF: A Randomized Controlled Trial at a County Hospital
Verified date | February 2024 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will compare opioid consumption in patients undergoing outpatient surgical fixation of distal radius fractures with and without standardized preoperative education at Grady Memorial Hospital.
Status | Terminated |
Enrollment | 5 |
Est. completion date | June 16, 2023 |
Est. primary completion date | June 16, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Any patient over the age of 18 years with a closed carpal, metacarpal, or distal radius fracture undergoing outpatient surgical management at Grady Memorial Hospital, who is willing to participate and mentally capable to consent. Exclusion Criteria: - Patients who are inpatients at the time of surgery. Patients who have concomitant injuries on the same extremity as the carpal, metacarpal, or distal radius fracture. Patients with open fractures. Patients unable to tolerate non-steroidal anti-inflammatory drugs (NSAIDs). Non-English speaking patients will be excluded. - Adults who are unable to consent will not be included. - Individuals who are not yet adults will not be included. - Pregnant women will not be included. - Prisoners will not be included. - Cognitively impaired individuals or individuals with impaired decision-making capacity will not be included. - Individuals who speak English will be included. Individuals who have limited English proficiency but speak Spanish as a primary language will not be eligible for inclusion. Spanish-speaking patients will be excluded because the components of the educational protocol (video, questionnaires, surveys) are not available in Spanish. |
Country | Name | City | State |
---|---|---|---|
United States | Grady Memorial Hospital | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University | American Society for Surgery of the Hand |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in total oral morphine equivalents consumed from day of surgery to postoperative day 10 | Change in oral morphine equivalents consumed from day of surgery to postoperative day 10 (POD 10). The total amount of morphine equivalents consumed between the 2 study arms will be compared. | Day of surgery, postoperative day 10 | |
Secondary | Total opioid consumption during the postoperative course | Total opioid consumption in mg during the postoperative course taken from the pain diary and postoperative questionnaire. | Up to postoperative day 10 | |
Secondary | Total number of opioid refills in the postoperative period | Number of opioid refills in the postoperative period based on postoperative questionnaire and prescription drug monitoring program (PDMP) database. | Up to postoperative day 10 | |
Secondary | Change in average daily VAS pain scores for early (postoperative day 0-3), middle (postoperative day 4-7), and late (postoperative day 8-10) postoperative period between the two study arms | Average visual analog scale (VAS) pain score will be collected for early (postoperative day 0-3), middle (postoperative day 4-7), and late (postoperative day 8-10) postoperative period from the pain diary, and results will be compared between both study arms. Total score ranges between 1-10 and 10 correlates with worse pain. | Baseline, postoperative day 0-3, postoperative day 4-7, postoperative day 8-10 | |
Secondary | Total number of unscheduled healthcare contact (UHC) up to 30 days after surgery | UHC includes telephone calls to clinical staff (documented in electronic medical record), early clinic visits, emergency room visits, and readmissions to the hospital | Up to 30 days after surgery | |
Secondary | Type of reason of unscheduled healthcare contact (UHC) up to 30 days after surgery | UHC includes telephone calls to clinical staff (documented in electronic medical record), early clinic visits, emergency room visits, and readmissions to the hospital. The reason will be collected from the day of surgery until 30 days after surgery. | Up to 30 days after surgery | |
Secondary | Change in results of Pain Management quiz after education | Change in results of Pain Management Quiz before and after education. Answers to the questions on the quiz are either correct or incorrect. Total number questions are 11. It will be measured as total number of correct answers/total number of questions (number of correct/11). This will be converted to a percentage correct. Range of score will be 0% - 100% correct. Higher change in percentage correct is a better outcome. Change in percentage correct from preoperative appointment to day of surgery will help determine the effectiveness of the educational protocol. | Preoperative, day of surgery | |
Secondary | Postoperative Satisfaction score with education | Based on the postoperative questionnaire, participants will answer a question about satisfaction with 5 possible answers: Very satisfied, Somewhat satisfied, Neutral, Somewhat dissatisfied and Very dissatisfied.
Results will be in percentage, based on number of participants in each category. "Very satisfied" correlates with better outcome with lower level of satisfaction until "very dissatisfied" that correlates with worse outcome. |
Postoperative (up to 2 weeks after surgery) | |
Secondary | Percentage of participants with adequate postoperative pain control | Based on the postoperative questionnaire, participants will answer a question about pain control:
"Do you feel like your pain was adequately controlled after surgery?" Possible answers include:Yes, No and Somewhat. Number of participants who answer "Yes" will be counted per randomization group. A higher result correlates with better outcome (better pain control). |
Postoperative (Up to 2 weeks after surgery) |
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