Obstetric Pain Management for Women With Opioid Use Disorder (QUEST)

Completed

• Conditions: Opioid-use Disorder
• Interventions: Other: Interview; Other: Surveys

• Registration Number: NCT04308655
• Lead Sponsor: University of Pittsburgh

Brief Summary

This is a mixed methods longitudinal observational study to assess patient and provider perspectives on pain and pain management among pregnant women with opiate use disorder (OUD). The findings from this study will inform patient-centered approaches to pain management. Themes surrounding mothers' pain/recovery experiences that correlate with quantified pain and analgesia endpoints will be identified. Findings will also shape an appropriate patient-centered research agenda for obstetric pain management in patients with OUD.

Detailed Description

A fine understanding of the attitudes and beliefs about pain and its management for patients with opioid use disorder is currently lacking. These psychological aspects of pain and analgesia are expected to have significant effects on nociception, pain experience, analgesic efficacy, and opioid requirements and its subsequent risks for relapse/treatment noncompliance. There is also have little understanding of provider-held attitudes and beliefs which can influence pain and its treatment for this population.

The findings from this study will inform patient-centered approaches to pain management for obstetric patients with OUD. They will also shape an appropriate patient-centered research agenda for obstetric pain management in patients with OUD. This work will find new patient-centered endpoints for this special population that may be currently overlooked with existing standard pain assessments.

Study Timeline

• Study Start: 2020-03-06
• Study First Submitted: 2020-03-06
• Study First Submitted QC: 2020-03-12
• Study First Posted: 2020-03-16
• Primary Completion: 2021-05-01
• Study Completion: 2022-03-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-06
• Last Update Posted: 2022-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 33

Inclusion Criteria

• Pregnant women who are 18 years of age or older
• History of opioid use disorder, on medication assisted therapy
• Currently in their third trimester

Exclusion Criteria

• Unable to participate in informed consent discussions
• Unable to give informed consent for any reason
• Not fluent in English (surveys are validated in English language)
• Unable to participate fully in all study procedures for any reason

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient participants	Interview	This cohort will include pregnant patients with a history of opiate use disorder (OUD) who will be followed from the third trimester of pregnancy until five days postpartum.
Patient participants	Surveys	This cohort will include pregnant patients with a history of opiate use disorder (OUD) who will be followed from the third trimester of pregnancy until five days postpartum.
Provider participants	Interview	This cohort will include clinicians who provide care for pregnant patients with OUD. Providers will be interviewed and will complete one survey cross-sectionally.

Primary Outcome Measures

Name	Time	Method
Themes surrounding mothers' pain/recover experience	Through study completion, an average of 6 weeks (from enrollment through labor and delivery)	The endpoint of this mixed-methods investigation is to identify themes surrounding mothers' pain/recovery experiences that correlate with quantified pain and analgesic needs. Endpoint will take the form of words/terms, phrases, or sentences. Identification of these terms, phases, or sentences are not identified a priori in this qualitative investigation.

Trial Locations

Locations (1)

UPMC Magee Womens Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States