Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06383845
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-14
Brief Title:
Comparison of Erector Spinae Plane Block vs Intravenous Lidocaine for Chronic Pain Post Mastectomy
Sponsor:
University Tunis El Manar
Organization:
University Tunis El Manar
Study Overview
Official Title:
Comparison of Erector Spinae Plane Block and Intravenous Lidocaine for Chronic Pain Post Mastectomy a Randomized Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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:
Patients undergoing breast surgery were divided into two groups Intravenous Lidocaine Lido-IV vs Erector Spinae Block ESP
For Lido-IV group patients received a loading dose of Lidocaine than a continuous infusion till the end of surgery
For ESP group an ultrasound guided ESP Block was perormed before anesthetic induction
Persistant pain post mastectomy was assessed by SFM-PQ score at 1 3 and 6 months post surgery
For Lido-IV group patients received a loading dose of Lidocaine than a continuous infusion till the end of surgery
For ESP group an ultrasound guided ESP Block was perormed before anesthetic induction
Persistant pain post mastectomy was assessed by SFM-PQ score at 1 3 and 6 months post surgery
Detailed Description:
Patients undergoing breast surgery with lymph node dissection were divided into two groups Intravenous Lidocaine Lido-IV vs Erector Spinae Block ESP
For Lido-IV group patients received a loading dose of 15 mgkg of Lidocaine than a continuous infusion of 2 mgkgh till the end of surgery
For ESP group an ultrasound guided ESP Block was perormed before anesthetic induction with injection of 30 ml of Ropivacaine 375
For both group persistant pain post mastectomy was assessed by Item 5 of BPI score at 1 3 and 6 months post surgery
For Lido-IV group patients received a loading dose of 15 mgkg of Lidocaine than a continuous infusion of 2 mgkgh till the end of surgery
For ESP group an ultrasound guided ESP Block was perormed before anesthetic induction with injection of 30 ml of Ropivacaine 375
For both group persistant pain post mastectomy was assessed by Item 5 of BPI score at 1 3 and 6 months post surgery
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