Preventive Analgesia in Multiparas Undergoing Induction of Labour

This study has been completed.
Sponsor:
Information provided by:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier:
NCT00465231
First received: April 23, 2007
Last updated: December 12, 2007
Last verified: December 2007
  Purpose

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.


Condition Intervention
Pain
Drug: bupivacaine, fentanyl
Drug: preservative free saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventive Analgesia in Labour:A Randomised, Placebo-Controlled Study in Multiparas Undergoing Induction of Labour

Resource links provided by NLM:


Further study details as provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:

Primary Outcome Measures:
  • Pain scores (VAS) remain 3 or less [ Time Frame: throughout the first stage of labor ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bupivacaine consumption [ Time Frame: during labour ] [ Designated as safety issue: No ]
  • Urinary creatinine to cortisol ratio [ Time Frame: during labour ] [ Designated as safety issue: No ]
  • Neonatal outcome [ Time Frame: at delivery ] [ Designated as safety issue: No ]
  • Obstetric outcome [ Time Frame: at delivery ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: January 2007
Study Completion Date: June 2007
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00465231

Locations
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Investigators
Principal Investigator: Jose CA Carvalho, MD PhD Mount Sinai Hospital, New York
  More Information

No publications provided

Responsible Party: Dr. Jose Carvalho, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT00465231     History of Changes
Other Study ID Numbers: 07-01, 06-0230-A
Study First Received: April 23, 2007
Last Updated: December 12, 2007
Health Authority: Canada: Ethics Review Committee

Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
Induction of labour
Bupivacaine consumption
Prevention

Additional relevant MeSH terms:
Bupivacaine
Fentanyl
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Narcotics
Analgesics
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid

ClinicalTrials.gov processed this record on April 17, 2014