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Paravertebral Block for Mastectomy With Immediate Reconstruction - Trial NCT06276257

Access comprehensive clinical trial information for NCT06276257 through Pure Global AI's free database. This phase not specified trial is sponsored by CHU de Quebec-Universite Laval and is currently Not yet recruiting. The study focuses on Postoperative Pain. Target enrollment is 60 participants.

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NCT06276257
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Trial Details
ClinicalTrials.gov โ€ข NCT06276257
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Paravertebral Block for Mastectomy With Immediate Reconstruction
Comparison Between Paravertebral Block and Usual Analgesia in Patients Undergoing Unilateral Total Mastectomy With Immediate Reconstruction

Study Focus

Postoperative Pain

Paravertebral block

Interventional

procedure

Sponsor & Location

CHU de Quebec-Universite Laval

Timeline & Enrollment

N/A

Mar 01, 2024

Dec 01, 2025

60 participants

Primary Outcome

Evaluation of postoperative pain using the BPI

Summary

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.

ICD-10 Classifications

Acute pain
Postoperative intestinal obstruction
Pain, unspecified
During surgical operation
During surgical operation

Data Source

ClinicalTrials.gov

NCT06276257

Non-Device Trial