Immediate and Chronic Pain After Mastectomy Managed With PECS Block or Local Infiltration
Conditions
Keywords
pain, mastectomy, PECS
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.
Interventions
OTHERPECS 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).
OTHERlocal 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).
Sponsors
Attikon Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
PATIENT OUTCOME ASSESSOR
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| intensity of acute postoperative pain | 24 hours | intensity of acute postoperative pain, numeric rating scale 0-10 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 the LANSS questionnaire |
Countries
Greece
Contacts
Primary ContactEleftheria Soulioti, MD,PhD
Backup ContactChrysanthi Batistaki, MD,PhD
Outcome results
None listed