Shared Decision Making for Prescription Opioids After Cesarean Delivery

The specific aim of this study is to use a shared decision making tool to allow women who have undergone cesarean delivery (CD) to choose the amount of oxycodone the participants will be prescribed at discharge, within a range from 0-40 tablets. The study investigators will document additional information from medical record abstraction (age, race/ethnicity, medical and obstetrical conditions, previous opioid use, date of CD, indication for CD, anesthetic management during CD, duration and complications of CD, length of stay, pain medication use and pain scores on each postoperative day between CD and discharge). The investigators will then follow up with the participants by telephone at two weeks after discharge to assess the amount of opioid used, frequency of prescription refill, disposition of unused medication, and participant satisfaction with their post-cesarean pain control. The investigators hypothesize that the use of a shared decision making tool will decrease the amount of opioid prescribed while still providing participants with satisfactory pain control.

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Key information

Conditions

Pregnancy Analgesics, Opioid Cesarean Section Prescriptions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Postpartum women who underwent a cesarean delivery at MGH

Exclusion criteria

Non-native English speakers (identified in LMR as "non-English speaking" or "requires interpreter")
Women with a history of chronic opioid abuse (identified in LMR as "opioid abuse" or "narcotic abuse")
Chronic pain on opioids (identified in LMR as "chronic pain" or "chronic narcotic use")
Women on methadone or buprenorphine for treatment of opioid addiction (identified from their medication list in the LMR)
Women with impaired decision-making abilities
Women hospitalized for > 7 days related to CD
Minors (<18 years old)
Women being prescribed an opioid other than oxycodone during their postpartum hospitalization (identified from the MAR and discussion with rounding providers)
Women with contraindications to taking acetaminophen or NSAIDs

Treatment and study plan

Prescribed opioids

Other

Making a shared decision with post-cesarean delivery mothers about quantity of opioids prescribed at discharge

Primary outcomes

Pain Management and Opioid Usage Measured by Telephone Questionnaire

Time frame: Within 2 weeks postpartum

Outpatient opioid selection and use after discharge

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: May 12, 2016
Registry last updated: Mar 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed