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NCT Number: NCT06276257

Paravertebral Block for 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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Quebec - Universite Laval

Québec, Quebec, G1H5B8, Canada

Location status: Recruiting

Location contact

Martin Beaumont

CONTACT

[email protected]

418-525-4444

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Usual analgesia

Procedure

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

Primary outcomes

  1. Evaluation of postoperative pain using the BPI

    Time frame: 24 hours, 28 hours, 72 hours after surgery

    Postoperative pain will be measured using the Brief Pain Inventory (BPI)

Secondary outcomes

  1. Total use of opioids received intraoperatively.

    Time frame: within 3 months after surgery

    Total dose of narcotics received intraoperatively (in mg morphine equivalent)

  2. Use of non-opioid analgesia intraoperatively

    Time frame: During surgery

    Analgesics other than opioids used intraoperatively

  3. Total dose of opioids received in the PACU

    Time frame: During PACU stay

    Total dose of narcotics received in the post-anesthesia care unit (PACU) (in mg morphine equivalent)

  4. Time before first opioid

    Time frame: Within 3 months after surgery

    Time to first opioid dose after surgery

  5. Total opioids consumed in the 48 hours following surgery

    Time frame: Within 48 hours after surgery

    Total quantity of opioids consumed in the 48 hours following surgery (in morphine equivalent)

  6. Chronic pain

    Time frame: At 3 months after surgery

    Presence of chronic pain at the surgical site at 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Charles Hogue

CONTACT

[email protected]

418-525-4444

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2024
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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