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Completed

NCT Number: NCT04888962

Quantitative Sensory Psychophysical Correlates of Pain in Pregnant Women With OUD

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.

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Key information

Conditions

Opioid-use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Pregnancy Related Substance-Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

OUD

Other

History of opioid use disorder.

Primary outcomes

  1. 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

  2. QST Pain Tolerance

    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 the sensation becomes uncomfortable.

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Acronym: Q-PRONTO

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 17, 2021
Registry last updated
Oct 5, 2021

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.

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