Quantitative Sensory Psychophysical Correlates of Pain in Pregnant Women With OUD

Study Overview
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Brief Summary
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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
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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.

Official Title
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Quantitative Sensory Psychophysical Correlates of Pain in Pregnant Women With OUD

Conditions
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Opioid-use Disorder, Pregnancy Related

Intervention / Treatment
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* Other: OUD


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective cohort group<br>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. | Other: OUD<br>* History of opioid use disorder.<br>|
| Control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QST Pain threshold | Quantitative sensory testing is a pain sensitivity test in which the patient will tell the investigator the moment they first feel pain | Completed at a time point antepartum/ before delivery | 
| QST Pain Tolerance | Quantitative sensory testing is a pain sensitivity test in which the patient will tell the investigator the moment the sensation becomes uncomfortable. | Completed at a time point antepartum/ before delivery | 
| QST Pain Threshold | Quantitative sensory testing is a pain sensitivity test in which the patient will tell the investigator the moment they first feel pain | Completed within 24 hours postpartum/ after delivery | 
| QST Pain Tolerance | Quantitative sensory testing is a pain sensitivity test in which the patient will tell the investigator the moment the sensation becomes uncomfortable. | Completed within 24 hours postpartum/ after delivery |