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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 18-70 years of age

• woman scheduled for unilateral mastectomy with immediate reconstruction

Locations
Other Locations
Canada
CHU de Quebec - Universite Laval
RECRUITING
Québec
Contact Information
Primary
Jean-Charles Hogue
jean-charles.hogue@crchudequebec.ulaval.ca
418-525-4444
Time Frame
Start Date: 2024-08-05
Estimated Completion Date: 2025-12
Participants
Target number of participants: 60
Treatments
Experimental: Paravertebral block
Preoperative paravertebral block on the side of mastectomy in addition to usual analgesia.
Active_comparator: Usual analgesia
Usual analgesia, as per anesthesiologist's preferences.
Sponsors
Leads: CHU de Quebec-Universite Laval

This content was sourced from clinicaltrials.gov