NCT04443894

Acute & Chronic Post-mastectomy Pain: Can PECS Block Alter the Geography?

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Attikon Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Immediate and Chronic Pain After Mastectomy Managed With PECS Block or Local Infiltration

Interventions

Type	Name	Description
OTHER	PECS block	PECS block is performed at the side of surgery (II) before incision with ropivacaine 0,375%.(30 ml). General anesthesia is induced and maintained with midazolam, fentanyl, propofol and rocuronium. Pain is assessed postoperatively according to protocol (24 hours and after 3 months).
OTHER	local infiltration	local infiltration of the surgical wound before incision with πwith ropivacaine 0,375%.(30 ml). General anesthesia is induced and maintained with midazolam, fentanyl, propofol and rocuronium. Pain is assessed postoperatively according to protocol (24 hours and after 3 months).

Timeline

• Start date: 2020-05-20
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2020-06-23
• Last updated: 2020-06-23

Locations

1 site across 1 country: Greece