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Preventive Analgesia in Multiparas Undergoing Induction of Labour

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ClinicalTrials.gov Identifier: NCT00465231
Recruitment Status : Completed
First Posted : April 24, 2007
Last Update Posted : December 17, 2007
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Pain 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventive Analgesia in Labour:A Randomised, Placebo-Controlled Study in Multiparas Undergoing Induction of Labour
Study Start Date : January 2007
Study Completion Date : June 2007

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
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

Outcome Measures

Primary Outcome Measures :
  1. Pain scores (VAS) remain 3 or less [ Time Frame: throughout the first stage of labor ]

Secondary Outcome Measures :
  1. Bupivacaine consumption [ Time Frame: during labour ]
  2. Urinary creatinine to cortisol ratio [ Time Frame: during labour ]
  3. Neonatal outcome [ Time Frame: at delivery ]
  4. Obstetric outcome [ Time Frame: at delivery ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00465231

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

Responsible Party: Dr. Jose Carvalho, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT00465231     History of Changes
Other Study ID Numbers: 07-01
First Posted: April 24, 2007    Key Record Dates
Last Update Posted: December 17, 2007
Last Verified: December 2007

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

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General