Preventive Analgesia in Multiparas Undergoing Induction of Labour

Study Overview
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Brief Summary
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Our study is about providing a better birthing experience by placing and initiating epidural for labour pain before the contractions start. This concept of prevention of pain before its onset is known as preventive - or preemptive -pain management and is well known in surgical and anaesthetic practice. We believe that the use of preventive epidural analgesia will improve the quality of labour epidurals, increase maternal satisfaction and reduce the stress response to labour and delivery.

Detailed Description
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Labour induces a well-documented stress response in both mother and fetus. Pain, anxiety and stress associated with labour result in the activation of the sympathetic nervous system, which increases plasma catecholamine concentrations with a resultant increase in cardiac output, peripheral vascular resistance and eventually, reduction in utero-placental perfusion. One aspect that has not been addressed in the literature is the role of preventive analgesia in labour. We believe that the use of preventive epidural analgesia will improve the quality of labour pain, increase maternal satisfaction and reduce the stress response in labour. The multiparous parturients that are scheduled for elective inductions of labour will be offered preventive epidural analgesia. Upon placing the epidural, patients will receive, in a double blind fashion, one of two possible epidural drug regimens, which are a saline placebo or 0.0625% bupivacaine with 2 micrograms of fentanyl per millilitre. The patient then undergoes routine induction and management of labour. At any point after induction of labour, patients in either group can request analgesia. Upon request for analgesia the standard epidural loading dose and infusion with PCEA is initiated. The primary outcome will be the success of analgesia (Verbal Analogue Scale of 3 or less) during the first stage of labor, from first request of epidural analgesia to full dilatation.

Official Title
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Preventive Analgesia in Labour:A Randomised, Placebo-Controlled Study in Multiparas Undergoing Induction of Labour

Conditions
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Pain

Intervention / Treatment
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* Drug: bupivacaine, fentanyl
* Drug: preservative free saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Multiparous patients who had previous vaginal delivery, undergoing induction of labour Singleton Pregnancy Exclusion Criteria: Morbid Obesity Patients who have received cortisol, opioids or sedatives within the last 24 hours

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Epidural | Drug: bupivacaine, fentanyl<br>* 10mL of 0.0625% of bupivacaine plus fentanyl 2 mcg/ml<br>|
| Placebo Comparator: 2<br>Epidural - saline solution | Drug: preservative free saline<br>* 10mL saline solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores (VAS) remain 3 or less |  | throughout the first stage of labor | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bupivacaine consumption |  | during labour | 
| Urinary creatinine to cortisol ratio |  | during labour | 
| Neonatal outcome |  | at delivery | 
| Obstetric outcome |  | at delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Induction of labour, Bupivacaine consumption, Prevention