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Completed

NCT Number: NCT02824302

3 Simple Questions to Predict Labor Pain and Epidural Analgesia Use in Parturients

Labor pain is complex to understand and challenging to define because of the interaction of multiple maternal and fetal factors. Poorly controlled acute post-procedural pain may result in harmful physiological and psychological consequences for both mother and baby. It is therefore important to understand the prelabor factors that may affect the labour pain to facilitate the intrapartum pain management. The goal of this prospective observational study is to verify if expectations regarding pain experience translate to actual pain outcomes for women who are undergoing induction of labor.

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Key information

Conditions

Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

London Health Science Centre

London, Ontario, Canada

About this study

A prospective observational cohort study. 100 parturients having induction of labor that match inclusion criteria will be asked to participate. After written informed consent, vital signs and patient demographics will be obtained and recorded. A 3 question survey will be given. Patients will be asked to rate, using a 0-10 cm visual analog scale (VAS), their anxiety level ("On a scale of 0-10 cm, with 0 being not anxious at all through 10 being extremely anxious, how anxious are you about your upcoming labor and delivery?"), their anticipated pain ("On a scale of 0-10, with 0 being no pain at all and 10 being pain as bad as you can imagine, how much pain do you anticipate experiencing during your upcoming labor and delivery?"), and using a categorical scale, to rate their anticipated epidural analgesic need ("On a scale of 0-5, with 0 being none at all, 1 being much less than average, 2 being less than average, 3 being average, 4 being more than average, and 5 being much more than average, how much epidural pain medication do you anticipate needing during your upcoming labor and delivery?"). Then 24 hours after delivery, patient VAS scores will be recorded, number of boluses, total number of hours of labor, patient comfort level and satisfaction

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The patient is 18 years or older
  • ASA class II or III according to the 2014 American Society of Anesthesiologists' physical status classification
  • The patient is having induction of labor
  • The patient is having a singleton pregnancy
  • the fetus's gestational age is more than 37 weeks
  • the patient is considering having epidural analgesia.

Exclusion criteria

  • The patient has refused to participate
  • There is a language barrier between the patient and the investigator
  • The patient received narcotics within the last two hours
  • the patient has chronic pain issues
  • There is significant concern about maternal or fetal welfare
  • The patient has a history of opioid tolerance
  • The patient has major psychiatric problem,
  • There is contraindication to epidural labor analgesia
  • Patient has allergy to local anesthetics.

Treatment and study plan

Survey

Other

Patients coming for induction of labor will be handed a survey regarding their expectation of their coming labor pain. And then will be followed up after 24 hours of their delivery.

Primary outcomes

  1. Area Under the Curve (AUC)

    Time frame: this outcome will measure the pain scores during labour from the start of epidural insertion until its discontinued.

    this outcome will be measured at day 1 of delivery

Secondary outcomes

  1. Time from onset of labor to epidural analgesia

    Time frame: minutes > 30 minutes

  2. Cervical dilatation at the time of request(cm)

    Time frame: hours (>1 hour)

  3. Pain score at the time of request of labor analgesia

    Time frame: VAS (1-10)

  4. Duration labor

    Time frame: hours (> 1 hour)

  5. Number of epidural boluses

    Time frame: hours (> 1 hour)

  6. Patient comfort during labor (1-5)

    Time frame: hours (>1 hour)

  7. Pain VAS during Epidural insertion (0-10)

    Time frame: hours (> 1 hour)

  8. Patient satisfaction with epidural analgesia

    Time frame: hours ( >1 hour)

  9. Mode of delivery

    Time frame: hours (>1 hour)

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Official study title

A Prospective Observational Study to Evaluate Efficacy of Simple Questions to Predict Labor Pain and Epidural Analgesia Use in Parturients

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 6, 2016
Registry last updated
Dec 11, 2018

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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