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

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

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04443894
• Other study ID #: BreastPecs
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2020
• Source: Attikon Hospital
• Contact: Eleftheria Soulioti, MD,PhD
• Phone: 00306946745366
• Email: eleftheriasoulioti[@]ymail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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).
• local infiltration
local infiltration of the surgical wound before incision with pwith 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).

Locations

Country	Name	City	State
Greece	2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Attikon Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intensity of acute postoperative pain	intensity of acute postoperative pain, numeric rating scale 0-10	24 hours
Secondary	intensity of chronic pain	intensity of chronic pain with numeric rating scale 0-10	3 months
Secondary	Prevalence of chronic neuropathic pain	Prevalence of chronic pain at the site of surgery, measured with the LANSS questionnaire	3 months
Secondary	Prevalence of chronic neuropathic pain	Prevalence of chronic pain at the site of surgery, measured with YES./NO	3 months