Preventive Analgesia in Multiparas Undergoing Induction of Labour

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Status: Completed

Conditions: Pain

Treatments: Drug: bupivacaine, fentanyl; Drug: preservative free saline

Study type: Interventional

Funder types: Other

Identifiers

NCT00465231

06-0230-A

07-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 16 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Epidural

Treatment:

Drug: bupivacaine, fentanyl

2

Placebo Comparator group

Description:

Epidural - saline solution

Treatment:

Drug: preservative free saline