Preventive Analgesia in Multiparas Undergoing Induction of Labour

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: bupivacaine, fentanyl; Drug: preservative free saline

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X5
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Investigators: Principal Investigator: Jose CA Carvalho, MD PhD, Mount Sinai Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Study Completion (Actual): June 1, 2007

Study Registration Dates

• First Submitted: April 23, 2007
• First Submitted That Met QC Criteria: April 23, 2007
• First Posted (Estimate): April 24, 2007

Study Record Updates

• Last Update Posted (Estimate): December 17, 2007
• Last Update Submitted That Met QC Criteria: December 12, 2007
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Keywords: Prevention; Induction of labour; Bupivacaine consumption
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Bupivacaine
• Other Study ID Numbers: 07-01; 06-0230-A