Breast/Surgery, Chronic Pain, Postoperative Complication
Conditions
Brief summary
This study compare the Serratus block plane (SPB) and the local infiltration of the tissue in the prevention of acute and chronic pain after breast cancer surgery.
Detailed description
Chronic pain after breast surgery may be severe, often requiring the use of morphine. The incidence of chronic pain varies from 27 to 50% depending on definitions. The infiltration of tissues by a local anesthetic is a simple, fast and low risk technique but of limited effectiveness. Serratus the flat block, performed under ultrasound guidance, is minimally invasive and easy to perform. It allows anesthesia and analgesia to an extended part of the anterolateral chest wall and the axilla. This regional anesthesia technique provides good analgesia during and after breast surgery, but remains to be evaluated; beyond perioperative analgesia, the benefit-risk, post operative rehabilitation, and the impact on ambulatory and on chronic pain are fundamental objectives.
Interventions
PROCEDUREserratus plane bloc : Ropivacaine 2mg/ml (0,3ml/kg)
PROCEDUREtissue infiltration : Ropivacaine 2mg/ml (0,3ml/kg)
PROCEDUREserratus plane bloc : placebo
PROCEDUREtissue infiltration : placebo
Sponsors
Erasme University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women scheduled for elective breast neoplasm surgery * Of ASA classification 1, 2 or 3 * Patients who provide written informed consent
Exclusion criteria
* Minor patients * Patients refusing to sign the consent * Patients included in another protocol within 3 months * Pregnant or lactating patients * Patients with history of allergy to local anesthetics (Ropivacaine) * Patients with contraindication to regional anesthesia (coagulopathy, local infection ...) * Patients with history of prior breast surgery (excluding diagnostic biopsy) * Patients with history of chronic pain * Patients with a history of psychiatric disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative chronic pain assessed using the DN4 questionnaire | 3 months postoperative | DN4 questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative acute pain | day 1, day 2, day 3 postoperative | Visual analogue scale (V.A.S.) |
| morphine consumption | day 1, day 2, day 3 postoperative | — |
Other
| Measure | Time frame |
|---|---|
| length of stay in the Postoperative Acute Care Unit | through study completion |
| length of stay in hospital | through study completion |
Contacts
Primary ContactCéline Boudart, MD
Backup ContactWendy Villareal Fernandez, MD
Outcome results
None listed