Instituto de Cancerología IDC Las Américas
Medellín, Antioquia, Colombia
NCT Number: NCT02609321
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%.
Looking for future studies?
Notify Me18 year–70 year
Female
Interventional
Phase 3
Medellín, Antioquia, Colombia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 24 hours
Acute pain at rest and in motion at 2, 4, 6, 12 and 24 hours post operative, measured by a visual analog scale (0-100 mm) for the paravertebral block group compared with the surgical wound infiltration group.
Time frame: 2 months
Compare the frequency and severity of adverse events in both groups
Time frame: 24 hours
Compare the total dose of self-administered opioids analgesics for the first 24 hours
Time frame: 24 hours
Compare the time to first dose of opioids analgesics in both groups
Time frame: 2 months
Compare the frequency of diagnosis of Post-mastectomy pain syndrome (SDP) two months after breast surgery in both groups
Time frame: 2 months
Estimate the changes in the quality of life of patients after two months after breast surgery in both groups
Instituto de Cancerología S.A.
Other
Efficacy of Thoracic Paravertebral Block vs Local Anesthesia of the Surgical Wound in Reduction of Acute Post-surgical Pain in Patients With Breast Cancer. Controlled Phase III, Randomized, Single-blind, Superiority Clinical Trial.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07724678
Agnosia, Breast Cancer
Altındağ, Ankara, Turkey (Türkiye)
View Trial DetailsNCT04275661
Agnosia, Analgesia
Asyut, Egypt
View Trial DetailsNCT06101849
Agnosia, Breast Cancer
Hamilton, Ontario, Canada
View Trial DetailsNCT06911892
Agnosia, Breast Cancer
Samsun, Ilkadim, Turkey (Türkiye)
View Trial Details