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

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ClinicalTrials.gov Identifier: NCT03219177
Recruitment Status : Recruiting
First Posted : July 17, 2017
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Ambulatory Hand Surgery Behavioral: Patient education regarding indications for opioid use and side effects of opioid use after hand surgery Other: Standard of care post-operative counseling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Patient Education and Use of Postoperative Pain Medication in Ambulatory Hand Surgery: a Randomized Controlled Trial
Actual Study Start Date : June 15, 2017
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

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.




Primary Outcome Measures :
  1. Number of prescription opioids used postoperatively [ Time Frame: Within 14 days of surgery ]

Secondary Outcome Measures :
  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.)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03219177


Contacts
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Contact: Hayley Sacks, BA 212-606-1440 sacksha@hss.edu

Locations
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United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Hayley Sacks, BA    212-606-1440    sacksha@hss.edu   
Sub-Investigator: Jeffrey Stepan, MD         
Principal Investigator: Duretti Fufa, MD         
Sponsors and Collaborators
Hospital for Special Surgery, New York

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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT03219177     History of Changes
Other Study ID Numbers: 2016-0330
First Posted: July 17, 2017    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Analgesics, Opioid
Analgesics
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents