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Narcotic Use After Minor Hand Surgery

NCT ID: NCT02970383

Last Updated: 2016-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-10-31

Brief Summary

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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

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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.

Conditions

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Pain, Postoperative Minor Surgical Procedures Narcotics Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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10 group

Initial prescription for 10 narcotic tabs

Group Type EXPERIMENTAL

Initial prescription for 10 narcotic tabs

Intervention Type BEHAVIORAL

Reduced number of pills in initial prescription post-operatively

30 group

Initial prescription for 30 narcotic tabs

Group Type ACTIVE_COMPARATOR

Inital prescription for 30 narcotic tabs

Intervention Type BEHAVIORAL

Interventions

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Initial prescription for 10 narcotic tabs

Reduced number of pills in initial prescription post-operatively

Intervention Type BEHAVIORAL

Inital prescription for 30 narcotic tabs

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Carilion Clinic

OTHER

Sponsor Role lead

Responsible Party

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Cassandra Mierisch

Orthopedic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cassandra Mierisch, MD

Role: PRINCIPAL_INVESTIGATOR

Carilion Clinic

References

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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.

Reference Type DERIVED
PMID: 31730554 (View on PubMed)

Other Identifiers

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MMR-CT-1

Identifier Type: -

Identifier Source: org_study_id