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NCT02782884 Clinical Trial

A Prospective Study of Post-operative Opioid Use in General Surgery Patients

Pain Clinical Trial

— GSopioids  

Official title:
A Prospective Study of Post-operative Opioid Use in General Surgical Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02782884
Other study ID # D16112
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 14, 2016
Est. completion date August 16, 2017

Study information
Verified date July 2018
Source Dartmouth-Hitchcock Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Patients undergoing approximately 10 common outpatient general surgical operations will be given a narcotic prescription for a specified number of pills.

Inpatients who are about to be discharged after surgery or trauma will be given narcotic prescriptions for a specified number of pills. Patients will be given a patient report form which they will use to record the number of pills they take each day and their daily pain score on a scale of 0-10.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date August 16, 2017
Est. primary completion date August 4, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- >= 18 years of age

- undergoing one of 9 elective outpatient operations: partial mastectomy, partial mastectomy and sentinel node biopsy, melanoma wide excision and sentinel node excision, thyroidectomy, parathyroidectomy, open inguinal hernia repair, laparoscopic inguinal hernia repair, laparoscopic cholecystectomy OR

- an inpatient on the general surgery service who took at least one oral narcotic

Exclusion Criteria:

- allergic to all narcotics

- chronic opioid use

- history of opioid or benzodiazepine abuse

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Dartmouth-Hitchcock Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary number of pills to satisfy 80% of patients opioid needs 1 yr
Secondary proportion of patients requiring narcotic refills when specified number of pills is given 1 year
Secondary patient pain level, daily 1 year
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