Recruiting

Paravertebral Block

Sponsor:

CHU de Quebec-Universite Laval

Code:

NCT06276257

Conditions

Postoperative Pain

Eligibility Criteria

Sex: Female

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Paravertebral block

Usual analgesia

Study Details

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

Study ID

NCT06276257

Start date

Aug 5, 2024

Status verified date

Mar, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Usual analgesia

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

Primary outcome measure

  • Evaluation of postoperative pain using the BPI [ Time Frame: 24 hours, 28 hours, 72 hours after surgery ]

Central Contacts and Locations

Locations

CHU de Quebec - Universite Laval

Recruiting

Québec, Quebec, Canada, G1H5B8

Contacts

More Information

Sponsor

CHU de Quebec-Universite Laval

Last update posted

Mar 19, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CHU de Quebec-Universite Laval on 2026-03-19.