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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

April 23, 2007
December 12, 2007
January 2007
Not Provided
Pain scores (VAS) remain 3 or less [ Time Frame: throughout the first stage of labor ] [ Designated as safety issue: No ]
Pain scores (VAS) remain 3 or less throughout the first stage of labor
Complete list of historical versions of study NCT00465231 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Bupivacaine consumption
  • Urinary creatinine to cortisol ratio
  • Neonatal outcome
  • Obstetric outcome
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Pain
  • Drug: bupivacaine, fentanyl
    10mL of 0.0625% of bupivacaine plus fentanyl 2 mcg/ml
  • Drug: preservative free saline
    10mL saline solution
  • Active Comparator: 1
    Epidural
    Intervention: Drug: bupivacaine, fentanyl
  • Placebo Comparator: 2
    Epidural - saline solution
    Intervention: Drug: preservative free saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
June 2007
Not Provided

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00465231
07-01, 06-0230-A
No
Dr. Jose Carvalho, Mount Sinai Hospital
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Not Provided
Principal Investigator: Jose CA Carvalho, MD PhD Mount Sinai Hospital, New York
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP