Paravertebral Block for Mastectomy With Immediate Reconstruction

NCT06276257 | Recruiting

• 1 other identifier: 2024-7301
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Total use of opioids received intraoperatively.

  within 3 months after surgery

• Use of non-opioid analgesia intraoperatively

  During surgery

• Total dose of opioids received in the PACU

  During PACU stay

• Time before first opioid

  Within 3 months after surgery

• Total opioids consumed in the 48 hours following surgery

  Within 48 hours after surgery

Study Arms (2)

Paravertebral block

EXPERIMENTAL

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

Procedure: Paravertebral block

Usual analgesia

ACTIVE COMPARATOR

Usual analgesia, as per anesthesiologist's preferences.

Procedure: Usual analgesia

Interventions

Paravertebral block 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.

Paravertebral block

Usual analgesia PROCEDURE

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

Usual analgesia

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• woman scheduled for unilateral mastectomy with immediate reconstruction

You may not qualify if:

• 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.

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead

Study Sites (1)

CHU de Quebec - Universite Laval

Québec, Quebec, G1H5B8, Canada

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Jean-Charles Hogue

CONTACT

418-525-4444; jean-charles.hogue@crchudequebec.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 23, 2024
• Study Start: August 5, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

CA (1)