NCT06276257

Paravertebral Block for Mastectomy With Immediate Reconstruction

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: CHU de Quebec-Universite Laval · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-08-05
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-02-23
• Last updated: 2026-03-19

Locations

1 site across 1 country: Canada