Paravertebral Block for Mastectomy with Immediate Reconstruction

Laval University

Status: Enrolling

Conditions: Postoperative Pain

Treatments: Procedure: Usual analgesia; Procedure: Paravertebral block

Study type: Interventional

Funder types: Other

Identifiers

NCT06276257

2024-7301

Details and patient eligibility

About

Following a mastectomy, patients may develop chronic pain, called post-mastectomy pain syndrome (PMPS). This syndrome manifests itself as complex neuropathic pain that seems linked to nerve damage suffered either during surgery, during healing or by nervous system dysfunction. However, the exact pathophysiology remains unknown. Typically, the pain is located on the ipsilateral side of the surgery and projects to the anterior thorax to the lateral thorax and may affect the proximal part of the arm. This pain persists for more than three months following the procedure and has the characteristics of neuropathic pain: burning sensation, tingling, electric shock, hyperalgesia, etc. The prevalence of PMDS varies between 2% and 78%; this disparity comes from the fact that there are no clear criteria in the literature for making the diagnosis. One of the risk factors for developing PMDS is the presence of acute pain immediately postoperatively.

The main objective of this study is to compare two analgesic modalities, namely BPV (study modality) and usual analgesia (control modality), in patients undergoing total mastectomy with immediate reconstruction under general anesthesia with the aim of to evaluate their functional pain score at 24, 48 and 72 hours following the surgical procedure.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-70 years of age
• woman scheduled for unilateral mastectomy with immediate reconstruction

Exclusion criteria

• Patients who will have an axillary dissection during surgery.
• Woman with severe hepatic insufficiency (Child Pugh Classification B and above24).
• Woman with kidney failure stage 4 and above25.
• Body mass index (BMI) > 40 kg/m2.
• Woman with an allergy to local anesthetics.
• Woman with a bleeding disorder in whom BPV is contraindicated.
• Woman in whom stopping antiplatelet or anticoagulant therapy does not allow compliance with the standards of practice of neuraxial anesthesia issued by the American Society of Regional Anesthesia.
• Woman with a single lung.
• Pregnant woman.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Paravertebral block

Experimental group

Description:

Preoperative paravertebral block on the side of mastectomy in addition to usual analgesia.

Treatment:

Procedure: Paravertebral block

Usual analgesia

Active Comparator group

Description:

Usual analgesia, as per anesthesiologist's preferences.

Treatment:

Procedure: Usual analgesia