Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
FEMALE
NCT06276257

Paravertebral Block for Mastectomy With Immediate Reconstruction

Led by CHU de Quebec-Universite Laval · Updated on 2026-03-19

60

Participants Needed

1

Research Sites

121 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Paravertebral Block for Mastectomy With Immediate Reconstruction

Who Can Participate

Age: 18Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 to 70 years
  • Scheduled for unilateral mastectomy with immediate reconstruction
Not Eligible

You will not qualify if you...

  • Planned axillary dissection during surgery
  • Severe liver insufficiency (Child Pugh B or above)
  • Kidney failure at stage 4 or higher
  • Body mass index greater than 40 kg/m2
  • Allergy to local anesthetics
  • Bleeding disorders contraindicating paravertebral block
  • Inability to stop antiplatelet or anticoagulant therapy as required for neuraxial anesthesia
  • Single lung condition
  • Pregnancy

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

CHU de Quebec - Universite Laval

Québec, Quebec, Canada, G1H5B8

Actively Recruiting

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Research Team

J

Jean-Charles Hogue

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Paravertebral Block for Mastectomy With Immediate Reconstruction | DecenTrialz