Clinical trial NCT02838173: Serratus Plane Block for the Prevention of Chronic Pain After Breast Cancer Surgery
Official title: Serratus Plane Block for the Prevention of Chronic Pain After Breast Cancer Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast/Surgery
Postoperative Complication
Chronic Pain
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2016-07-20
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: postoperative chronic pain assessed using the DN4 questionnaire
timeFrame: 3 months postoperative
Secondary outcomes:
measure: postoperative acute pain
timeFrame: day 1, day 2, day 3 postoperative
measure: morphine consumption
timeFrame: day 1, day 2, day 3 postoperative
Other outcomes:
measure: length of stay in the Postoperative Acute Care Unit
timeFrame: through study completion
measure: length of stay in hospital
timeFrame: through study completion
Locations:
Study officials:
affiliation: Erasme hospital
name: Luc Van Obbergh, MD PhD
role: STUDY_DIRECTOR
References:
citation: Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.
citation: Andreae MH, Andreae DA. Regional anaesthesia to prevent chronic pain after surgery: a Cochrane systematic review and meta-analysis. Br J Anaesth. 2013 Nov;111(5):711-20. doi: 10.1093/bja/aet213. Epub 2013 Jun 28.