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Clinical Trials/NCT06276257
NCT06276257RecruitingNot Applicable

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

CHU de Quebec-Universite Laval2 sites in 1 country60 target enrollmentStarted: August 5, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
60
Locations
2
Primary Endpoint
Evaluation of postoperative pain using the BPI

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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 above
  • Body mass index (BMI) > 40 kg/m
  • 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.

Outcomes

Primary Outcomes

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

  • Chronic pain(At 3 months after surgery)
  • Total opioids consumed in the 48 hours following surgery(Within 48 hours after surgery)
  • Use of non-opioid analgesia intraoperatively(During surgery)
  • Time before first opioid(Within 3 months after surgery)
  • Total use of opioids received intraoperatively.(within 3 months after surgery)
  • Total dose of opioids received in the PACU(During PACU stay)

Investigators

Sponsor
CHU de Quebec-Universite Laval
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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