Quantitative Sensory Psychophysical Correlates of Pain in Pregnant Women With OUD

NCT ID: NCT04888962

Last Updated: 2021-10-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 13 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-14
• Study Completion Date: 2021-09-30

Brief Summary

This is a prospective observational case-control study comparing quantitative sensory testing data preformed during the third trimester of pregnancy and within 24 hours postpartum in women on medication-assisted treatment for opioid use disorder (OUD) to a gestational age-controlled cohort of women who do not have OUD.

The primary goal is to measure elements of quantitative sensory testing including temperature pain threshold, temperature pain tolerance, and thermal and mechanical temporal summation for patients with opioid use disorder on medication-assisted treatment (MAT), and compare these results to gestational age matched controlled pregnant patients not on MAT.

Detailed Description

The objective of this study is to measure elements of quantitative sensory testing including temperature pain threshold, temperature pain tolerance, and thermal and mechanical temporal summation for patients with opioid use disorder on medication-assisted treatment (MAT), and compare these results to gestational age matched controlled pregnant patients not on MAT.

The hypothesis is that women requiring maintenance opioids during pregnancy will have a significant difference in pain sensitivity in the third trimester and immediately postpartum as compared to women who did not require maintenance opioids during pregnancy.

Conditions

Opioid-use Disorder; Pregnancy Related

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Prospective cohort group

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 24 hours postpartum.

OUD

Intervention Type: OTHER

History of opioid use disorder.

Control group

This cohort will include pregnant patients without a history of opiate use disorder (OUD) who will be followed from the third trimester of pregnancy until 24 hours postpartum.

No interventions assigned to this group

Interventions

OUD

History of opioid use disorder.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Subjects that will be included in the prospective cohort group:

• individuals at least 18 years of age
• at least 28 weeks gestation (third trimester)
• on medication-assisted treatment for opioid use disorder, including methadone or suboxone.

Patients who will be included in the control group:

• individuals at least 18 years of age
• at least 28 weeks gestation (third trimester)
• have not been on been on opioids in the past 12 months.

Exclusion Criteria

• Those who are 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 including sensory deficits, scar tissue, or infection at any QST sites.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Grace Lim, MD, MS

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Grace Lim, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY20060069

Identifier Type: -

Identifier Source: org_study_id