Ignite Creation Date:
2024-05-06 @ 3:07 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04531215
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2020-08-25
Brief Title:
Ultrasound Guided Retrolaminar Versus Erector Spinae Plane Block for Postoperative Analgesia
Sponsor:
Zagazig University
Organization:
Zagazig University
Study Overview
Official Title:
Ultrasound Guided Retrolaminar Versus Erector Spinae Plane Block for Postoperative Analgesia in Modified Radical Mastectomy
Status:
RECRUITING
Status Verified Date:
2024-02
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:
Thoracic epidural anesthesia TEA and paravertebral block PVB have been utilized to give perioperative regional anesthesia in the trunk TEA is technically troublesome in some cases and is associated with a danger of serious complications such as epidural hematoma nerve injury and hypotension PVB has the benefit of perception of the needle position using ultrasonography However PVB is also additionally connected with a danger of serious complications such as pneumothorax hypotension or nerve injury Newer approaches to deal with PVB have been the focal point of numerous techniques lately these methodologies incorporate retrolaminar block RLB and erector spinae plane block ESPB
Detailed Description:
Modified radical mastectomy is one of the commonly performed breast surgery Postoperative pain following mastectomy should be minimized as in a number of women it may chronically persist for months in the form of post-mastectomy pain syndrome
Morphine administration for acute pain after mastectomy surgery has many side effects Regional block techniques as para-vertebral block and thoracic epidural anesthesia have possible complications and technical difficulties
The new alternative regional techniques such as erector spinae plane block and retrolaminar block are clinical trials for providing a safe and easy with good hemodynamic and recovery profile with adequate perioperative analgesia for a large section of patients undergoing mastectomy operation in order to reduce opioids consumption and subsequently avoid opioid-related adverse effects
As percent of post-operative rescue analgesia is 167 and 60 for RLB group and ESPB group respectively So sample size is 46 patients 23 patients in each group Sample was calculated using OPEN EPI program with confidence level 95 and power 80
Morphine administration for acute pain after mastectomy surgery has many side effects Regional block techniques as para-vertebral block and thoracic epidural anesthesia have possible complications and technical difficulties
The new alternative regional techniques such as erector spinae plane block and retrolaminar block are clinical trials for providing a safe and easy with good hemodynamic and recovery profile with adequate perioperative analgesia for a large section of patients undergoing mastectomy operation in order to reduce opioids consumption and subsequently avoid opioid-related adverse effects
As percent of post-operative rescue analgesia is 167 and 60 for RLB group and ESPB group respectively So sample size is 46 patients 23 patients in each group Sample was calculated using OPEN EPI program with confidence level 95 and power 80
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