Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-27 @ 7:48 AM
Study NCT ID:
NCT04443894
Status:
UNKNOWN
Last Update Posted:
2020-06-23
First Post:
2020-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute & Chronic Post-mastectomy Pain: Can PECS Block Alter the Geography?
Sponsor:
Attikon Hospital
Organization:
Study Overview
Official Title:
Acute & Chronic Post-mastectomy Pain: Can PECS Block Alter the Geography?
Status:
UNKNOWN
Status Verified Date:
2020-06
Last Known Status:
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:
Post mastectomy pain management is of crucial importance for patients' rehabilitation and quality of life. PECS block is used for acute and chronic post mastectomy pain management. Surgical infiltration is also used in this field. Patients in our study are divided in two groups receiving PECS block or surgical infiltrationbefore incision. Multimodal analgesia is indispensable according to recent guidelines for enhanced postoperative recovery. Pain scores will be assessed during the first 24h postoperatively and at 3 months after surgery.
Detailed Description:
Patients are randomly assigned to 2 groups, PECS block or surgical infiltration group. Patients assigned to PECS group will receive 30cc of ropivacaine 0,375% where 10cc will be injected between pectoralis major and pectoralis minor and 20cc between pectoralis minor and serratus anterior muscle under ultrasound guidance. Patients assigned to surgical infiltration group will receive 30cc of ropivacaine 0,375% injected by the surgeon. Local aneshetic is administered in both groups after the induction of general anesthesia and before incision. Pain will be assessed at 1, 12, 24h after surgery and at three months after surgery communicating by telephone. Post operative analgesia includes paracetamol 1gr, parecoxib 40 mg (as required) and tramadol as rescue analgesia (1 mg/kg iv up to 3 times daily). Chronic pain will be assessed after 3 months as for prevalence and neuropathic characteristics.
Study Oversight
Has Oversight DMC:
False
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?: