Back to resultsNarcotic Use After Minor Hand Surgery
Primary Purpose
Pain, Postoperative, Minor Surgical Procedures, Narcotics Use
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Initial prescription for 10 narcotic tabs
Inital prescription for 30 narcotic tabs
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility Criteria
Inclusion Criteria:
- patients undergoing minor hand surgery by a participating surgeon within the study period
Exclusion Criteria:
- narcotic use within previous 3 months
- concurrent procedure
- acute trauma
- pregnancy
- allergy or other contraindication or intolerance to hydrocodone or acetaminophen
- post-operative complications
- inability to provide personal consent to the procedure or the research
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
10 group
30 group
Arm Description
Initial prescription for 10 narcotic tabs
Initial prescription for 30 narcotic tabs
Outcomes
Primary Outcome Measures
Narcotic used
number of narcotic tabs taken by patient (5mg hydrocodone/325 mg acetaminophen)
Secondary Outcome Measures
Number of refills requested
number of times patient requested additional pain medication
Number of left over tabs
Number of left over usable narcotic tabs remaining in patient possession
Patient reported efficacy of pain control
Patient reported satisfaction with pain control
Patient reported satisfaction with overall surgical experience
Patient Opinion Regarding Appropriateness of Size of Initial Prescription
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02970383
Brief Title
Narcotic Use After Minor Hand Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Carilion Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the effect of larger or smaller opioid prescriptions following minor surgery on the amount of narcotic used, patient reported satisfaction, refill requests, and leftover narcotic.
Detailed Description
Patients are randomized to receive prescriptions for either 10 or 30 tabs of 5 mg hydrocodone/325 mg acetaminophen following minor hand surgery. Patients are allowed to request additional medication as needed. Patients are contacted by phone 10-14 days after their surgery to answer a questionnaire regarding number of pills taken, number of refills requested, number of remaining pills, their satisfaction with their pain control and their surgery, and their opinion regarding the appropriateness of the prescription size.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Minor Surgical Procedures, Narcotics Use
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
10 group
Arm Type
Experimental
Arm Description
Initial prescription for 10 narcotic tabs
Arm Title
30 group
Arm Type
Active Comparator
Arm Description
Initial prescription for 30 narcotic tabs
Intervention Type
Behavioral
Intervention Name(s)
Initial prescription for 10 narcotic tabs
Intervention Description
Reduced number of pills in initial prescription post-operatively
Intervention Type
Behavioral
Intervention Name(s)
Inital prescription for 30 narcotic tabs
Primary Outcome Measure Information:
Title
Narcotic used
Description
number of narcotic tabs taken by patient (5mg hydrocodone/325 mg acetaminophen)
Time Frame
10-14 days post-op
Secondary Outcome Measure Information:
Title
Number of refills requested
Description
number of times patient requested additional pain medication
Time Frame
10-14 days post-op
Title
Number of left over tabs
Description
Number of left over usable narcotic tabs remaining in patient possession
Time Frame
10-14 days post-op
Title
Patient reported efficacy of pain control
Time Frame
10-14 days post-op
Title
Patient reported satisfaction with pain control
Time Frame
10-14 days post-op
Title
Patient reported satisfaction with overall surgical experience
Time Frame
10-14 days post-op
Title
Patient Opinion Regarding Appropriateness of Size of Initial Prescription
Time Frame
10-14 days post-op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients undergoing minor hand surgery by a participating surgeon within the study period
Exclusion Criteria:
narcotic use within previous 3 months
concurrent procedure
acute trauma
pregnancy
allergy or other contraindication or intolerance to hydrocodone or acetaminophen
post-operative complications
inability to provide personal consent to the procedure or the research
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cassandra Mierisch, MD
Organizational Affiliation
Carilion Clinic
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
none currently
Citations:
PubMed Identifier
31730554
Citation
Gaddis A, Dowlati E, Apel PJ, Bravo CJ, Dancea HC, Hagan HJ, Mierisch CM, Metzger TA, Mierisch C. Effect of Prescription Size on Opioid Use and Patient Satisfaction After Minor Hand Surgery: A Randomized Clinical Trial. Ann Surg. 2019 Dec;270(6):976-982. doi: 10.1097/SLA.0000000000003127.
Results Reference
derived
Learn more about this trial
Narcotic Use After Minor Hand Surgery
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