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

NCT02824302 | Completed

• 1 other identifier: 107817
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Labor Pain

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve (AUC)

  this outcome will be measured at day 1 of delivery

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

Secondary Outcomes (9)

• Time from onset of labor to epidural analgesia

  minutes > 30 minutes

• Cervical dilatation at the time of request(cm)

  hours (>1 hour)

• Pain score at the time of request of labor analgesia

  VAS (1-10)

• Duration labor

  hours (> 1 hour)

• Number of epidural boluses

  hours (> 1 hour)

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy full term pregnant patients with singleton pregnancy

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

London Health Science Centre

London, Ontario, Canada

Location

Related Publications (3)

• Pan PH, Tonidandel AM, Aschenbrenner CA, Houle TT, Harris LC, Eisenach JC. Predicting acute pain after cesarean delivery using three simple questions. Anesthesiology. 2013 May;118(5):1170-9. doi: 10.1097/ALN.0b013e31828e156f.

  PMID: 23485992 RESULT

• Carvalho B, Zheng M, Harter S, Sultan P. A Prospective Cohort Study Evaluating the Ability of Anticipated Pain, Perceived Analgesic Needs, and Psychological Traits to Predict Pain and Analgesic Usage following Cesarean Delivery. Anesthesiol Res Pract. 2016;2016:7948412. doi: 10.1155/2016/7948412. Epub 2016 Apr 7.

  PMID: 27143966 RESULT

• Carvalho B, Zheng M, Aiono-Le Tagaloa L. A prospective observational study evaluating the ability of prelabor psychological tests to predict labor pain, epidural analgesic consumption, and maternal satisfaction. Anesth Analg. 2014 Sep;119(3):632-640. doi: 10.1213/ANE.0000000000000357.

  PMID: 25029661 RESULT

MeSH Terms

Conditions

Labor Pain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2016
• First Posted: July 6, 2016
• Study Start: July 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: May 1, 2017
• Last Updated: December 11, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)