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

NCT ID: NCT02824302

Last Updated: 2018-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-05-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Labor Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Survey

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. The patient has refused to participate
2. There is a language barrier between the patient and the investigator
3. The patient received narcotics within the last two hours
4. the patient has chronic pain issues
5. There is significant concern about maternal or fetal welfare
6. The patient has a history of opioid tolerance
7. The patient has major psychiatric problem,
8. There is contraindication to epidural labor analgesia
9. Patient has allergy to local anesthetics.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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London Health Science Centre

London, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type RESULT
PMID: 23485992 (View on PubMed)

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.

Reference Type RESULT
PMID: 27143966 (View on PubMed)

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.

Reference Type RESULT
PMID: 25029661 (View on PubMed)

Other Identifiers

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107817

Identifier Type: -

Identifier Source: org_study_id