NCT02408393

MIRs03: Paravertebral Block With Ropivacaine Before Breast Cancer Surgery

MIRs03: A Double-blind Randomized Trial of Paravertebral Block With Ropivacaine Before Breast Cancer Surgery: Effects on Chronic Postoperative Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 380 (actual)
• Sponsor: Institut Curie · Academic / Other
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Compare the effect of paravertebral block (PVB) with Ropivacaine or placebo on the incidence of chronic pain 3 months after breast cancer surgery.

Detailed description

Before anesthesia, the second or third intercostal space is located. After an aspiration, 0.35 mL/kg of solution (ropivacaine 7.5 mg/mL or saline, maximum 30 mL) are injected into the paravertebral space. After 30 minutes, spread of PVB is evaluated by cold test on skin. Then, general anesthesia is induced. Evaluation of the frequency of chronic pain at 3, 6 and 12 months by the Brief Pain Inventory (BPI) questionnaire and Neuropathic Pain Diagnostic (DN4) and Anxiety and depression evaluation by the Hospital Anxiety and Depression questionnaire (HAD) will be done.

Conditions

• Malignant Neoplasm of Breast

Interventions

Type	Name	Description
DRUG	Saline
DRUG	Ropivacaine

Timeline

• Start date: 2015-03-27
• Primary completion: 2018-07-01
• Completion: 2019-03-09
• First posted: 2015-04-03
• Last updated: 2019-07-10

Locations

6 sites across 1 country: France