Clinical Trials Directory

Trials / Terminated

TerminatedNCT05237531

Preoperative Education in Hand and Wrist Surgery

Preop Education and Opioid Use After Hand and Wrist Fracture ORIF: A Randomized Controlled Trial at a County Hospital

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
5 (actual)
Sponsor
Emory University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALStandardized Preoperative EducationThe standardized preoperative education includes a brief video, an interactive quiz, and a written handout. The video will provide information on the proper use and common side effects of opioid pain medications, the expected effects of a peripheral nerve block, and the concept of multimodal postoperative pain management with non-opioid medications and non-pharmaceutical pain management strategies. The interactive quiz will reinforce the critical components of the video in a question-and-answer format which requires active participation. The written handout will summarize the educational content in a form which can be easily referenced by patients at home.
BEHAVIORALStandard of careEducation per provider preference (no standardization, current standard of care)
BEHAVIORALPreoperative and postoperative questionnairesPreoperative questionnaire: Demographic questions plus specific questions about chronic pain, prior opioid use, and mental health diagnoses Postoperative questionnaire: Questions about pain control after surgery, satisfaction with pain control, healthcare contact since surgery, opioid consumption since surgery, and satisfaction with education

Timeline

Start date
2022-03-15
Primary completion
2023-06-16
Completion
2023-06-16
First posted
2022-02-14
Last updated
2024-02-22

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05237531. Inclusion in this directory is not an endorsement.

Preoperative Education in Hand and Wrist Surgery (NCT05237531) · Clinical Trials Directory