Paravertebral Block for Mastectomy With Immediate Reconstruction

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorCHU de Quebec-Universite Laval

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

18-70 years of age

woman scheduled for unilateral mastectomy with immediate reconstruction

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Paravertebral block

    Procedure/Surgery

    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/Surgery

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Paravertebral blockExperimental treatment 1 intervention
Group B: Usual analgesiaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Evaluation of postoperative pain using the BPI

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

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

Secondary outcomes

1

Total use of opioids received intraoperatively.

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

Time frame
within 3 months after surgery
2

Use of non-opioid analgesia intraoperatively

Analgesics other than opioids used intraoperatively

Time frame
During surgery
3

Total dose of opioids received in the PACU

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

Time frame
During PACU stay
4

Time before first opioid

Time to first opioid dose after surgery

Time frame
Within 3 months after surgery

Other outcomes

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