Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00465231
Status:
COMPLETED
Last Update Posted:
2007-12-17
First Post:
2007-04-23
Brief Title:
Preventive Analgesia in Multiparas Undergoing Induction of Labour
Sponsor:
Samuel Lunenfeld Research Institute Mount Sinai Hospital
Organization:
Samuel Lunenfeld Research Institute Mount Sinai Hospital
Study Overview
Official Title:
Preventive Analgesia in LabourA Randomised Placebo-Controlled Study in Multiparas Undergoing Induction of Labour
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 00625 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
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 00625 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-0230-A | None | None | None |