Paravertebral Block for Mastectomy with Immediate Reconstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-05

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Paravertebral block

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

Group Type EXPERIMENTAL

Paravertebral block

Intervention Type PROCEDURE

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.

Usual analgesia

Usual analgesia, as per anesthesiologist's preferences.

Group Type ACTIVE_COMPARATOR

Usual analgesia

Intervention Type PROCEDURE

The patient will receive analgesia as per the anesthesiologist's preferences.

Interventions

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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.

Intervention Type PROCEDURE

Usual analgesia

The patient will receive analgesia as per the anesthesiologist's preferences.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No