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

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02824302
• Other study ID #: 107817
• Status: Completed
• Start date: July 2016
• Est. completion date: May 2017

Study information

• Verified date: December 2018
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Labor Pain

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	London Health Science Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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):632-40. doi: — View Citation

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. 201 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time from onset of labor to epidural analgesia		minutes > 30 minutes
Secondary	Cervical dilatation at the time of request(cm)		hours (>1 hour)
Secondary	Pain score at the time of request of labor analgesia		VAS (1-10)
Secondary	Duration labor		hours (> 1 hour)
Secondary	Number of epidural boluses		hours (> 1 hour)
Secondary	Patient comfort during labor (1-5)		hours (>1 hour)
Secondary	Pain VAS during Epidural insertion (0-10)		hours (> 1 hour)
Secondary	Patient satisfaction with epidural analgesia		hours ( >1 hour)
Secondary	Mode of delivery		hours (>1 hour)