Paravertebral Block for Mastectomy With Immediate Reconstruction

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06276257
• Other study ID #: 2024-7301
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: CHU de Quebec-Universite Laval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of postoperative pain using the BPI	Postoperative pain will be measured using the Brief Pain Inventory (BPI)	24 hours, 28 hours, 72 hours after surgery
Secondary	Total use of opioids received intraoperatively.	Total dose of narcotics received intraoperatively (in mg morphine equivalent)	within 3 months after surgery
Secondary	Use of non-opioid analgesia intraoperatively	Analgesics other than opioids used intraoperatively	During surgery
Secondary	Total dose of opioids received in the PACU	Total dose of narcotics received in the post-anesthesia care unit (PACU) (in mg morphine equivalent)	During PACU stay
Secondary	Time before first opioid	Time to first opioid dose after surgery	Within 3 months after surgery
Secondary	Total opioids consumed in the 48 hours following surgery	Total quantity of opioids consumed in the 48 hours following surgery (in morphine equivalent)	Within 48 hours after surgery
Secondary	Chronic pain	Presence of chronic pain at the surgical site at 3 months	At 3 months after surgery