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

A

Attikon University Hospital

Status

Unknown

Conditions

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

Treatments

Other: local infiltration
Other: PECS block

Study type

Interventional

Funder types

Other

Identifiers

NCT04443894
BreastPecs

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

PECS block
Active Comparator group
Treatment:
Other: PECS block
local infiltration
Active Comparator group
Treatment:
Other: local infiltration

Trial contacts and locations

1

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Central trial contact

Eleftheria Soulioti, MD,PhD; Chrysanthi Batistaki, MD,PhD

Data sourced from clinicaltrials.gov

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