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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Patient education group	Behavioral: Patient education regarding indications for opioid use and side effects of opioid use after hand surgery; Patients in the active education group will be given information pre-operatively on the current opioid epidemic, alternative pain management strategies that should be tried before proceeding to prescription opioid use, appropriate indications for opioid use, and side effects of opioids.This information will be reinforced by the research coordinator and nursing staff in the post-anesthesia care unit.
ACTIVE_COMPARATOR: Control- Standard of care counseling	Other: Standard of care post-operative counseling; Patients will receive standard of care post-operative counseling. They will not be given pre or post-operative opioid education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of prescription opioids used postoperatively	Within 14 days of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	This will be measured on a Likert scale, as used in most orthopedics research.	Post-op day 3, 8, and 15
Pain level	Numeric Rating Scale pain scores	Post-op day 3, 8, 15
Surgical factors	Type of surgery, length of surgery, type and amount of anesthesia	Recorded on day of surgery
Pain Catastrophization Score	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.	Measured pre-operatively
Mindfulness Attention Awareness Scale Score	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.	Measured pre-operatively
Adverse reactions to pain medication	Side effects of opioid and non-opioid medications will be assessed	Post-op day 3, 8, 15
Prescriptions filled and refilled	We will assess whether patients both initially filled and re-filled their opioid prescriptions	Post-op day 3, 8, 15
Alternative analgesia used	We will identify if patients use any alternative pain management strategies (i.e., elevation, icing, breathing exercises, mediation, etc.)	Post-op day 3, 8, 15

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 15, 2017
• Primary Completion (ACTUAL): December 6, 2022
• Study Completion (ACTUAL): December 6, 2022

Study Registration Dates

• First Submitted: July 13, 2017
• First Submitted That Met QC Criteria: July 13, 2017
• First Posted (ACTUAL): July 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 16, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: 2016-0330

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No