Narcotic Use After Minor Hand Surgery

Pain, Postoperative Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02970383
• Other study ID #: MMR-CT-1
• Status: Completed
• Phase: N/A
• First received: November 18, 2016
• Last updated: November 18, 2016
• Start date: October 2015
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: Carilion Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Minor Surgical Procedures
• Narcotics Use
• Pain, Postoperative

Intervention

Behavioral:
• Initial prescription for 10 narcotic tabs
Reduced number of pills in initial prescription post-operatively
• Inital prescription for 30 narcotic tabs

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Carilion Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Narcotic used	number of narcotic tabs taken by patient (5mg hydrocodone/325 mg acetaminophen)	10-14 days post-op	Yes
Secondary	Number of refills requested	number of times patient requested additional pain medication	10-14 days post-op	No
Secondary	Number of left over tabs	Number of left over usable narcotic tabs remaining in patient possession	10-14 days post-op	Yes
Secondary	Patient reported efficacy of pain control		10-14 days post-op	No
Secondary	Patient reported satisfaction with pain control		10-14 days post-op	No
Secondary	Patient reported satisfaction with overall surgical experience		10-14 days post-op	No
Secondary	Patient Opinion Regarding Appropriateness of Size of Initial Prescription		10-14 days post-op	No