Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04776512
Status:
UNKNOWN
Last Update Posted:
2021-03-01
First Post:
2021-02-23
Brief Title:
Erector Spinae Plane Block Versus Classic Epidural Analgesia in Labor
Sponsor:
Mongi Slim Hospital
Organization:
Mongi Slim Hospital
Study Overview
Official Title:
Lumbar Erector Spinae Plane Block Versus Classic Epidural Analgesia in Labor
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
NOT_YET_RECRUITING
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:
ProsepectiveRandomized controlled study enrolling full termed parturients admitted for vaginal delivery
At the sencond stage of labor 3cm of cervix dilatation patients will be randomized in 2 groups
ESP group patients will receive ultrasound guided bilateral ESP Block performed at the level of the 3 rd Lumbar transverse process
Epidural Analgesia Group Patients will have a classic lumbar continuous epidural analgesia
At the sencond stage of labor 3cm of cervix dilatation patients will be randomized in 2 groups
ESP group patients will receive ultrasound guided bilateral ESP Block performed at the level of the 3 rd Lumbar transverse process
Epidural Analgesia Group Patients will have a classic lumbar continuous epidural analgesia
Detailed Description:
ProsepectiveRandomized controlled study enrolling full termed parturients admitted for vaginal delivery
At the sencond stage of labor 3cm of cervix dilatation patients will be randomized in 2 groups
ESP group patients will receive ultrasound guided bilateral ESP Block performed at the level of the 3 rd Lumbar transverse process
Epidural Analgesia Group Patients will have a classic lumbar continuous epidural analgesia
For the first group 20 ml of 0375 isobaric Bupivacain solution will be injected bilaterally under ultrasound direct vision
Concerning the second group patients will have a continuous injection of 0125 Bupivacain solution associated to 025 mcg of Sufentanilml through an epidural catheter in the L3-L4 or L4-L5 intervertebral space
For the 2 groups analgesia will be assessed during all the labor period hourly using the Visual Analog pain Score VAS
At the sencond stage of labor 3cm of cervix dilatation patients will be randomized in 2 groups
ESP group patients will receive ultrasound guided bilateral ESP Block performed at the level of the 3 rd Lumbar transverse process
Epidural Analgesia Group Patients will have a classic lumbar continuous epidural analgesia
For the first group 20 ml of 0375 isobaric Bupivacain solution will be injected bilaterally under ultrasound direct vision
Concerning the second group patients will have a continuous injection of 0125 Bupivacain solution associated to 025 mcg of Sufentanilml through an epidural catheter in the L3-L4 or L4-L5 intervertebral space
For the 2 groups analgesia will be assessed during all the labor period hourly using the Visual Analog pain Score VAS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None