Efficacy of Thoracic Paravertebral Block in the Reduction of Acute Post-surgical Pain in Patients With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      Surgical treatment of breast cancer is frequently associated with postoperative pain in the
      surgical area. Persistent pain after breast cancer management has considerable negative
      effects on the quality of life of survivors. The aim of this trials is to evaluate the
      efficacy of thoracic paravertebral block with bupivacine 0.5% in reducing the acute pain
      postmastectomy compare with surgical wound infiltration with bupivacaine 0.5%.
    

Detailed description: 
      Surgical treatment of breast cancer is frequently associated with postoperative pain in the
      surgical area, restricted movement of the ipsilateral upper limb and increased risk of
      chronic pain. This usually occurs even though management with analgesics commonly used in the
      postoperative period. Properly treatment of acute postoperative pain have essential
      implications: improving the general welfare of patients, can better withstand future medical
      interventions, facilitating recovery in the short and long term and is believed to have
      positive impact on survival from cancer.

      Persistent pain after breast cancer management has considerable negative effects on the
      quality of life of survivors. Several risks factors have been described in preoperative,
      intra-operative and postoperative periods of persistent or chronic pain. In the postoperative
      period the most important risk factor is the severity of acute pain. For this, pain relief is
      an essential component of care of patients undergoing breast cancer surgery. Current evidence
      suggests that treatment of acute postoperative pain reduces the risk of persistent or chronic
      pain syndrome. The surgical wound infiltration with local anesthesia has been used routinely
      in patients managed at the Cancer Institute and Clinica Las Americas and is described as a
      safe and accessible procedure for the management of acute postoperative pain. Paravertebral
      block represents an interesting alternative in the management of perioperative pain, often
      used for breast surgery, hernia repair and thoracotomy in children and adults. Although
      complications associated with blocking are uncommon, the implementation of Ultrasound-guided
      approach has become the standard for performing said method.

      Such considerations have led us to evaluate whether patients with breast cancer who are
      undergoing mastectomy, thoracic paravertebral block could be better in relief acute pain in
      comparison with surgical wound infiltration with local anesthesia. This will be studied by
      controlled randomized to one of two intervention groups (paravertebral block or local
      anesthesia with infiltration of the surgical wound) allocation trial. In all patients,
      general anesthesia and routine postoperative analgesic is used.
    

Intervention name(s): Thoracic Paravertebral Block; Surgical Wound Infiltration
Intervention type(s): Procedure; Procedure
Intervention description(s): Thoracic paravertebral block at T3 level with bupivacaine 0.5%, dosis 1.5mg/Kg; Surgical wound infiltration on the skin and subcutaneous tissue in surgical area with bipivacaine 0.5%, dosis 1.5mg/kg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Paravertebral; Single injection; Breast surgery; Analgesia