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