Preventive Analgesia in Multiparas Undergoing Induction of Labour
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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 |
- Pain scores (VAS) remain 3 or less [ Time Frame: throughout the first stage of labor ] [ Designated as safety issue: No ]
- 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 |
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| Canada, Ontario | |
| Mount Sinai Hospital | |
| Toronto, Ontario, Canada, M5G 1X5 | |
| 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 June 18, 2013