Ignite Creation Date:
2024-05-06 @ 1:27 AM
Last Modification Date:
2024-10-26 @ 11:04 AM
Study NCT ID:
NCT01810406
Status:
COMPLETED
Last Update Posted:
2014-04-23
First Post:
2013-03-11
Brief Title:
Epidural Volume Extension During a Combined Spinal-Epidural Technique for Labor Analgesia
Sponsor:
IWK Health Centre
Organization:
IWK Health Centre
Study Overview
Official Title:
A Randomized Controlled Trial of Epidural Volume Extension During a Combined Spinal-Epidural Technique for Labor Analgesia
Status:
COMPLETED
Status Verified Date:
2014-04
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:
Combined spinal-epidurals CSE involve the injection of pain relief medication into the cerebral spinal fluid CSF and the insertion of an epidural catheter in the epidural space to continue to give pain relief medication During a CSE after injection of the medication in the CSF and before inserting the epidural catheter if normal saline is injected into the epidural space there may be an increase in pain relief and an increase in the level of numbness This injection of saline in the epidural space to increase pain relief and numbness is termed epidural volume extension EVE The purpose of this study is to determine if there is a benefit for EVE to improve labor analgesia pain relief using CSE in pregnant laboring patients
Detailed Description:
Regional analgesia pain relief for labor can be an epidural a spinal or a combination of the two Combined spinal-epidurals CSE are popular because of their rapid pain relief and high patient satisfaction At the IWK Health Centre many anesthesiologists routinely use this method of pain relief It involves the injection of pain relief medication into the cerebral spinal fluid CSF and the insertion of an epidural catheter slim plastic tube in the epidural space to continue to give pain relief medication The epidural space is located just outside the CSF In order to insert the epidural catheter some anesthesiologists inject 2-4 ml of saline in the epidural space to help the catheter go in During a CSE after injection of the medication in the CSF and before inserting the epidural catheter if normal saline is injected into the epidural space there may be an increase in pain relief and an increase in the level of numbness This injection of saline in the epidural space to increase pain relief and numbness is termed epidural volume extension EVE
Thus far studies on EVE have all been done in patients undergoing surgery with spinal anesthesia and not solely for analgesia The purpose of this study is to determine if there is a benefit for EVE to improve labor analgesia pain relief using CSE We will study 60 women requesting labor pain relief Half these women will receive a CSE without EVE which is the present standard of care The other half will receive a CSE with 10 ml of saline for EVE before inserting the epidural catheter We will then determine if there is a benefit for EVE by observing for a difference between the two groups with respect to the level of numbness the amount and speed of pain relief and the intensity of leg weakness We hypothesize that injecting 10 ml of saline for EVE using CSE may improve the amount and speed of pain relief while decreasing side effects such as leg weakness If there were a benefit to EVE this would be a simple and inexpensive method for improving pain relief in laboring women
Thus far studies on EVE have all been done in patients undergoing surgery with spinal anesthesia and not solely for analgesia The purpose of this study is to determine if there is a benefit for EVE to improve labor analgesia pain relief using CSE We will study 60 women requesting labor pain relief Half these women will receive a CSE without EVE which is the present standard of care The other half will receive a CSE with 10 ml of saline for EVE before inserting the epidural catheter We will then determine if there is a benefit for EVE by observing for a difference between the two groups with respect to the level of numbness the amount and speed of pain relief and the intensity of leg weakness We hypothesize that injecting 10 ml of saline for EVE using CSE may improve the amount and speed of pain relief while decreasing side effects such as leg weakness If there were a benefit to EVE this would be a simple and inexpensive method for improving pain relief in laboring women
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