Clinical trial NCT05237531: Preoperative Education in Hand and Wrist Surgery
Official title: Preop Education and Opioid Use After Hand and Wrist Fracture ORIF: A Randomized Controlled Trial at a County Hospital
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Distal Radius Fracture
Keywords: ORIF
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: American Society for Surgery of the Hand
First posted: 2022-02-14
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The proposed research aims to study the impact of preoperative education on postoperative pain control after outpatient surgery for traumatic wrist fractures. The impact of preoperative education will be studied through patient questionnaires and by tracking postoperative opioid consumption as well as instances of unscheduled healthcare contact after surgery. The study will be a randomized controlled trial. This study imposes no more than minimal risk to study participants. Loss of privacy and breach of confidentiality are risks of this study. All data will be stored securely on Microsoft One Drive, a password-protected, encrypted database which requires two-factor authorization. The study population will be patients aged 18-99 years who are undergoing outpatient surgical management of distal radius fractures at Grady Memorial Hospital. No vulnerable populations will be included. Contact will be made with potential study participants at their preoperative clinic visit. Written informed consent will be obtained. Data will not be publicly available. Data will be deidentified, and no members of the team will have access to the code that identifies patients. Data will be collected in the plastic surgery clinic, orthopedic surgery clinic, and preoperative area at Grady Memorial Hospital. The total respondent burden will be 30 minutes.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in total oral morphine equivalents consumed from day of surgery to postoperative day 10
timeFrame: Day of surgery, postoperative day 10
Secondary outcomes:
measure: Total opioid consumption during the postoperative course
timeFrame: Up to postoperative day 10
measure: Total number of opioid refills in the postoperative period
timeFrame: Up to postoperative day 10
measure: 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
timeFrame: Baseline, postoperative day 0-3, postoperative day 4-7, postoperative day 8-10
measure: Total number of unscheduled healthcare contact (UHC) up to 30 days after surgery
timeFrame: Up to 30 days after surgery
measure: Type of reason of unscheduled healthcare contact (UHC) up to 30 days after surgery
timeFrame: Up to 30 days after surgery
measure: Change in results of Pain Management quiz after education
timeFrame: Preoperative, day of surgery
measure: Postoperative Satisfaction score with education
timeFrame: Postoperative (up to 2 weeks after surgery)
measure: Percentage of participants with adequate postoperative pain control
timeFrame: Postoperative (Up to 2 weeks after surgery)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Paul Ghareeb, MD
role: PRINCIPAL_INVESTIGATOR
References: