Paravertebral Block for Mastectomy With Immediate Reconstruction

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: Paravertebral block; Procedure: Usual analgesia

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean-Charles Hogue; Phone Number: 418-525-4444; Email: jean-charles.hogue@crchudequebec.ulaval.ca

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1H5B8
      • Recruiting
      • CHU de Québec - Université Laval
      • Contact: Martin Beaumont; Phone Number: 418-525-4444; Email: Martin.Beaumont@chudequebec.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Paravertebral block; Preoperative paravertebral block on the side of mastectomy in addition to usual analgesia.	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.
Active Comparator: Usual analgesia; Usual analgesia, as per anesthesiologist's preferences.	Procedure: Usual analgesia; The patient will receive analgesia as per the anesthesiologist's preferences.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of postoperative pain using the BPI	Postoperative pain will be measured using the Brief Pain Inventory (BPI)	24 hours, 28 hours, 72 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total use of opioids received intraoperatively.	Total dose of narcotics received intraoperatively (in mg morphine equivalent)	within 3 months after surgery
Use of non-opioid analgesia intraoperatively	Analgesics other than opioids used intraoperatively	During surgery
Total dose of opioids received in the PACU	Total dose of narcotics received in the post-anesthesia care unit (PACU) (in mg morphine equivalent)	During PACU stay
Time before first opioid	Time to first opioid dose after surgery	Within 3 months after surgery
Total opioids consumed in the 48 hours following surgery	Total quantity of opioids consumed in the 48 hours following surgery (in morphine equivalent)	Within 48 hours after surgery
Chronic pain	Presence of chronic pain at the surgical site at 3 months	At 3 months after surgery

Collaborators and Investigators

• Sponsor: CHU de Quebec-Universite Laval

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 14, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative
• Other Study ID Numbers: 2024-7301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No