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Completed

NCT Number: NCT03219177

Patient Education and Use of Post Operative 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.

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Key information

Conditions

Ambulatory Hand Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Special Surgery

New York, 10021, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient education regarding indications for opioid use and side effects of opioid use after hand surgery

Behavioral

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.

Standard of care post-operative counseling

Other

Patients will receive standard of care post-operative counseling. They will not be given pre or post-operative opioid education.

Primary outcomes

  1. Number of prescription opioids used postoperatively

    Time frame: Within 14 days of surgery

Secondary outcomes

  1. Patient satisfaction

    Time frame: Post-op day 3, 8, and 15

    This will be measured on a Likert scale, as used in most orthopedics research.

  2. Pain level

    Time frame: Post-op day 3, 8, 15

    Numeric Rating Scale pain scores

  3. Surgical factors

    Time frame: Recorded on day of surgery

    Type of surgery, length of surgery, type and amount of anesthesia

  4. Pain Catastrophization Score

    Time frame: 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.

  5. Mindfulness Attention Awareness Scale Score

    Time frame: 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.

  6. Adverse reactions to pain medication

    Time frame: Post-op day 3, 8, 15

    Side effects of opioid and non-opioid medications will be assessed

  7. Prescriptions filled and refilled

    Time frame: Post-op day 3, 8, 15

    We will assess whether patients both initially filled and re-filled their opioid prescriptions

  8. Alternative analgesia used

    Time frame: 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.)

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jul 17, 2017
Registry last updated
Dec 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.