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

Not Applicable

• Conditions: Immediate and Chronic Pain After Mastectomy Managed With PECS Block or Local Infiltration
• Interventions: Other: PECS block; Other: local infiltration

• Registration Number: NCT04443894
• Lead Sponsor: Attikon Hospital

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 Timeline

• Study Start: 2020-05-20
• Status Verified: 2020-06
• Study First Submitted: 2020-06-21
• Study First Submitted QC: 2020-06-21
• Last Update Submitted: 2020-06-21
• Study First Posted: 2020-06-23
• Last Update Posted: 2020-06-23
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• over 18 years of age
• ASA physical status I-III
• elective partial mastectomy

Exclusion Criteria

• refusal of patient participation or inability to participate to the study

  • known allergic reaction to drugs included in the study design
  • contraindiations of performance of peripheral regional anesthesia
  • diabetes melitus or known neurological disorder
  • chronic pain disorders under therapy with opioids or other analgesic drugs for chronic pain
  • all male patients
  • all patients not speaking the Greek language

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PECS block	PECS block	-
local infiltration	local infiltration	-

Primary Outcome Measures

Name	Time	Method
intensity of acute postoperative pain	24 hours	intensity of acute postoperative pain, numeric rating scale 0-10

Secondary Outcome Measures

Name	Time	Method
intensity of chronic pain	3 months	intensity of chronic pain with numeric rating scale 0-10
Prevalence of chronic neuropathic pain	3 months	Prevalence of chronic pain at the site of surgery, measured with YES./NO

Trial Locations

Locations (1)

2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.; 🇬🇷 Athens, Greece