Preoperative Education in Hand and Wrist Surgery

NCT05237531 | Terminated

• 1 other identifier: STUDY00003074
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Distal Radius Fracture

Keywords

ORIF

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Total opioid consumption during the postoperative course

  Up to postoperative day 10

• Total number of opioid refills in the postoperative period

  Up to postoperative day 10

• 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

  Baseline, postoperative day 0-3, postoperative day 4-7, postoperative day 8-10

• Total number of unscheduled healthcare contact (UHC) up to 30 days after surgery

  Up to 30 days after surgery

• Type of reason of unscheduled healthcare contact (UHC) up to 30 days after surgery

  Up to 30 days after surgery

Study Arms (2)

Experimental Arm

EXPERIMENTAL

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.

Behavioral: Standardized Preoperative Education; Behavioral: Preoperative and postoperative questionnaires

Control Arm

ACTIVE COMPARATOR

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.

Behavioral: Standard of care; Behavioral: Preoperative and postoperative questionnaires

Interventions

Standardized Preoperative Education BEHAVIORAL

The 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.

Experimental Arm

Standard of care BEHAVIORAL

Education per provider preference (no standardization, current standard of care)

Control Arm

Preoperative and postoperative questionnaires BEHAVIORAL

Preoperative 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

Control Arm; Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• American Society for Surgery of the Hand: collaborator

Study Sites (1)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Wrist Fractures

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Paul Ghareeb, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 14, 2022
• Study Start: March 15, 2022
• Primary Completion: June 16, 2023
• Study Completion: June 16, 2023
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date
• Access Criteria: * Anyone who wishes to access the data * Any purpose * Data will be available indefinitely

Locations

US (1)