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Clinical Trials/NCT04888962
NCT04888962
Completed
N/A

Quantitative Sensory Psychophysical Correlates of Pain in Pregnant Women With OUD

University of Pittsburgh1 site in 1 country13 target enrollmentJune 14, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Opioid-use Disorder
Sponsor
University of Pittsburgh
Enrollment
13
Locations
1
Primary Endpoint
QST Pain Threshold
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 14, 2021
End Date
September 30, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Grace Lim, MD, MS

Associate Professor

University of Pittsburgh

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.

Outcomes

Primary Outcomes

QST Pain Threshold

Time Frame: Completed within 24 hours postpartum/ after delivery

Quantitative sensory testing is a pain sensitivity test in which the patient will tell the investigator the moment they first feel pain

QST Pain Tolerance

Time Frame: Completed within 24 hours postpartum/ after delivery

Quantitative sensory testing is a pain sensitivity test in which the patient will tell the investigator the moment the sensation becomes uncomfortable.

QST Pain threshold

Time Frame: Completed at a time point antepartum/ before delivery

Quantitative sensory testing is a pain sensitivity test in which the patient will tell the investigator the moment they first feel pain

Study Sites (1)

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