Preventive Analgesia in Multiparas Undergoing Induction of Labour

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00465231
• Other study ID #: 07-01
• Secondary ID: 06-0230-A
• Status: Completed
• Phase: N/A
• First received: April 23, 2007
• Last updated: December 12, 2007
• Start date: January 2007
• Est. completion date: June 2007

Study information

• Verified date: December 2007
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• bupivacaine, fentanyl
10mL of 0.0625% of bupivacaine plus fentanyl 2 mcg/ml
• preservative free saline
10mL saline solution

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scores (VAS) remain 3 or less		throughout the first stage of labor	No
Secondary	Bupivacaine consumption		during labour	No
Secondary	Urinary creatinine to cortisol ratio		during labour	No
Secondary	Neonatal outcome		at delivery	No
Secondary	Obstetric outcome		at delivery	No