Preoperative Education in Hand and Wrist Surgery

Emory University

Status: Terminated

Conditions: Distal Radius Fracture

Treatments: Behavioral: Standard of care; Behavioral: Preoperative and postoperative questionnaires; Behavioral: Standardized Preoperative Education

Study type: Interventional

Funder types: Other

Identifiers

NCT05237531

STUDY00003074

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Experimental Arm

Experimental group

Description:

Patients in the experimental arm will receive standardized preoperative education in the form of a brief video, interactive quiz, and written handout. All patients will receive standardized multimodal pain management consisting of a long-acting peripheral nerve block, scheduled non-opioid pain medications, an opioid prescription to be taken only as needed, and adjunctive medicines to be taken as needed for any side effects.

Treatment:

Behavioral: Standardized Preoperative Education

Behavioral: Preoperative and postoperative questionnaires

Control Arm

Active Comparator group

Description:

Patients in the control arm will receive education per the provider's preference (current standard of care). All patients will receive standardized multimodal pain management consisting of a long-acting peripheral nerve block, scheduled non-opioid pain medications, an opioid prescription to be taken only as needed, and adjunctive medicines to be taken as needed for any side effects.

Treatment:

Behavioral: Preoperative and postoperative questionnaires

Behavioral: Standard of care