Efficacy of Thoracic Paravertebral Block in the Reduction of Acute Post-surgical Pain in Patients With Breast Cancer
NCT ID: NCT02609321
Last Updated: 2016-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
60 participants
INTERVENTIONAL
2015-11-30
2016-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Thoracic Paravertebral Block
to identify the thoracic T3, a parallel line 2.5 cm from the spinous process is drawn and in this place the ultrasound sensor is placed. Ultrasonograph image identifies the transverse process, the intercostal cost-transverse ligament, the pleura and lung. We proceed to insert a needle between the two corresponding transverse processes and positions after passing the cost-ligament posterior intercostal and transverse to the parietal pleura. After negative aspiration for blood, 0.5% bupivacaine anesthetic is administered at doses of 1.5 mg/kg slowly. The volume is defined by the anesthesiologist. The injection of anesthetic is displayed, as well as confirmation of the correct location of the needle because the volume injected above pushes the pleura.
Thoracic Paravertebral Block
Thoracic paravertebral block at T3 level with bupivacaine 0.5%, dosis 1.5mg/Kg
Surgical Wound Infiltration
before the close of the skin, it proceeds to infiltrate the subcutaneous tissue and skin with 0.5% bupivacaine at doses of 1.5 mg/kg, generating the widest possible dissemination of the bupivacaine in the surgical area.
Surgical Wound Infiltration
Surgical wound infiltration on the skin and subcutaneous tissue in surgical area with bipivacaine 0.5%, dosis 1.5mg/kg
Interventions
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Thoracic Paravertebral Block
Thoracic paravertebral block at T3 level with bupivacaine 0.5%, dosis 1.5mg/Kg
Surgical Wound Infiltration
Surgical wound infiltration on the skin and subcutaneous tissue in surgical area with bipivacaine 0.5%, dosis 1.5mg/kg
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of breast cancer requiring major elective surgery: unilateral mastectomy with or without axillary dissection; with or without axillary sentinel node biopsy; with or without immediate breast reconstruction.
3. Willingness to participate in the study during the follow-up period.
Exclusion Criteria
2. Medical History of coagulopathy.
3. Consumption of anticoagulants.
4. Contraindication to NSAIDs or opioids.
5. Allergy to local anesthetics of amide type.
6. Infection a interventions sites (paravertebral block or area affected breast surgical wound)
7. Pregnancy and lactation.
8. BMI\>35.
9. Parkinson's disease, Alzheimer's disease or other diseases that affect the mental or motor sphere.
10. Double mastectomy or mastectomy history of previous ipsilateral to the current episode.
11. Preoperative risk classification ASA IV-V.
18 Years
70 Years
FEMALE
No
Sponsors
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Instituto de Cancerología S.A.
OTHER
Responsible Party
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Principal Investigators
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Fernando Herazo, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Instituto de Cancerología IDC Las Américas
Hector I García, MD, MPH, MSc
Role: PRINCIPAL_INVESTIGATOR
Instituto de Cancerología IDC Las Américas
Jorge A Egurrola, MD
Role: PRINCIPAL_INVESTIGATOR
Instituto de Cancerología IDC Las Américas
Locations
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Instituto de Cancerología IDC Las Américas
Medellín, Antioquia, Colombia
Countries
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References
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Kairaluoma PM, Bachmann MS, Korpinen AK, Rosenberg PH, Pere PJ. Single-injection paravertebral block before general anesthesia enhances analgesia after breast cancer surgery with and without associated lymph node biopsy. Anesth Analg. 2004 Dec;99(6):1837-1843. doi: 10.1213/01.ANE.0000136775.15566.87.
Sidiropoulou T, Buonomo O, Fabbi E, Silvi MB, Kostopanagiotou G, Sabato AF, Dauri M. A prospective comparison of continuous wound infiltration with ropivacaine versus single-injection paravertebral block after modified radical mastectomy. Anesth Analg. 2008 Mar;106(3):997-1001, table of contents. doi: 10.1213/ane.0b013e31816152da.
Other Identifiers
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IDC0001
Identifier Type: -
Identifier Source: org_study_id