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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain

• Study Type: Observational
• Enrollment (Actual): 50

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

>= 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 in the 24 hrs prior to discharge

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Outpatient general surgery operation; Patients undergoing outpatient general surgical operations They will be given a specified number of narcotic pills based on our retrospective analysis of patient post-operative opioid use
Inpatient general surgical patients; Inpatients who are being discharged They will be given a specified number of narcotic pills based on the number of pills they took in the 24 hrs prior to discharge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of pills to satisfy 80% of patients opioid needs	1 yr

Secondary Outcome Measures

Outcome Measure	Time Frame
proportion of patients requiring narcotic refills when specified number of pills is given	1 year
patient pain level, daily	1 year

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Investigators: Principal Investigator: Richard J Barth, MD, Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2016
• Primary Completion (Actual): August 4, 2017
• Study Completion (Actual): August 16, 2017

Study Registration Dates

• First Submitted: May 22, 2016
• First Submitted That Met QC Criteria: May 24, 2016
• First Posted (Estimate): May 25, 2016

Study Record Updates

• Last Update Posted (Actual): July 30, 2018
• Last Update Submitted That Met QC Criteria: July 26, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: post-operative pain
• Other Study ID Numbers: D16112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO