Patient Education and Use of Post Operative Pain Medication in Ambulatory Hand Surgery: a Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Ambulatory Hand Surgery
• Interventions: Behavioral: Patient education regarding indications for opioid use and side effects of opioid use after hand surgery; Other: Standard of care post-operative counseling

• Registration Number: NCT03219177
• Lead Sponsor: Hospital for Special Surgery, New York

Brief Summary

There is a current opioid epidemic in the United States partially fueled by excess prescribing practices after surgery. The objective of this study is to decrease the amount of opioids needed after ambulatory hand surgery. In this randomized control trial, patients will be randomized into a patient education group and into a control group. The education group will be provided with a pre-operative video detailing proper indications for opioid use after hand surgery, alternative pain management strategies to try before using prescription opioid medications, and side effects associated with opioid use. Patients will also receive information on the current opioid epidemic. Patients will be reminded of the information given pre-operatively after surgery in the post-anesthesia care unit. The control group will not receive pre-operative education and will only receive standard of care post-operative counseling by nursing in the post-anesthesia care unit. All patients will be given a pain log, pain medication diary and participate in phone/email surveys to determine number of opioid pills taken, pain levels, and satisfaction with surgery. The investigators hypothesize that the education group will have decreased opioid intake and increased patient satisfaction compared to the control group.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-15
• Study First Submitted: 2017-07-13
• Study First Submitted QC: 2017-07-13
• Study First Posted: 2017-07-17
• Status Verified: 2022-12
• Primary Completion: 2022-12-06
• Study Completion: 2022-12-06
• Last Update Submitted: 2022-12-14
• Last Update Posted: 2022-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• English Speaking: must be able to communicate over the phone or by email to perform questionnaires
• Primary elective ambulatory hand surgery (bony or soft tissue)

Bony: Scaphoidectomy/ligament reconstruction tendon interposition (LRTI), Arthrodesis, Arthroplasty Soft Tissue: Carpal tunnel release (CTR), Trigger Finger (TF), DeQuervain's (DQ), Cyst removal, Cubital tunnel, Dupuytren's, tendon transfer, arthroscopy of wrist or elbow

Exclusion Criteria

• Disability or preop pain in ipsilateral upper extremity from a secondary condition not related to the study procedure
• Allergy or inability to consume oxycodone, Percocet or Vicodin due to a particular health state
• Current Substance Abuse
• HSS employees

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient education group	Patient education regarding indications for opioid use and side effects of opioid use after hand surgery	-
Control- Standard of care counseling	Standard of care post-operative counseling	-

Primary Outcome Measures

Name	Time	Method
Number of prescription opioids used postoperatively	Within 14 days of surgery

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	Post-op day 3, 8, and 15	This will be measured on a Likert scale, as used in most orthopedics research.
Pain level	Post-op day 3, 8, 15	Numeric Rating Scale pain scores
Surgical factors	Recorded on day of surgery	Type of surgery, length of surgery, type and amount of anesthesia
Pain Catastrophization Score	Measured pre-operatively	This validated scale is one of the most widely used instruments to evaluate catastrophic thinking related to pain. It specifically evaluates patients' feelings of helplessness and frequency of rumination on and magnification of pain.
Mindfulness Attention Awareness Scale Score	Measured pre-operatively	This validated scale assesses dispositional mindfulness and has been shown to tap a unique quality of consciousness that is associated with self-regulation and well-being constructs.
Adverse reactions to pain medication	Post-op day 3, 8, 15	Side effects of opioid and non-opioid medications will be assessed
Prescriptions filled and refilled	Post-op day 3, 8, 15	We will assess whether patients both initially filled and re-filled their opioid prescriptions
Alternative analgesia used	Post-op day 3, 8, 15	We will identify if patients use any alternative pain management strategies (i.e., elevation, icing, breathing exercises, mediation, etc.)

Trial Locations

Locations (1)

Hospital for Special Surgery; 🇺🇸 New York, New York, United States