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Recruiting NCT06276257

Paravertebral Block for Mastectomy With Immediate Reconstruction

No phase Interventional Postoperative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Paravertebral block, Usual analgesia.
Who it may be relevant to
Registry conditions: Postoperative Pain. Basic parameters: 18 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparison Between Paravertebral Block and Usual Analgesia in Patients Undergoing Unilateral Total Mastectomy With Immediate Reconstruction

Overview

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.

Interventions

  • Procedure Paravertebral block
    An ultrasound-guided technique will be used to inject a volume of 40 mL of ropivacaine 0.2%, up to a maximum of 1.5 mg/kg, into the paravertebral space between the T3 and T4 vertebrae.
  • Procedure Usual analgesia
    The patient will receive analgesia as per the anesthesiologist's preferences.

Primary outcome measures

  • Evaluation of postoperative pain using the BPI [Time frame: 24 hours, 28 hours, 72 hours after surgery]
Secondary outcome measures (6)
  • Total use of opioids received intraoperatively. [Time frame: within 3 months after surgery]
  • Use of non-opioid analgesia intraoperatively [Time frame: During surgery]
  • Total dose of opioids received in the PACU [Time frame: During PACU stay]
  • Time before first opioid [Time frame: Within 3 months after surgery]
  • Total opioids consumed in the 48 hours following surgery [Time frame: Within 48 hours after surgery]
  • Chronic pain [Time frame: At 3 months after surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Canada · 1 center
  • CHU de Quebec - Universite Laval — Québec

Identifiers

NCT: NCT06276257 · 2024-7301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗