Efficacy of Thoracic Paravertebral Block in the Reduction of Acute Post-surgical Pain in Patients With Breast Cancer

NCT02609321 | Completed Phase 3

• 1 other identifier: IDC0001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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%.

Conditions

Breast Cancer

Keywords

Paravertebral; Single injection; Breast surgery; Analgesia

Outcome Measures

Primary Outcomes (1)

• Acute post-surgical pain at rest and motion

  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.

  24 hours

Secondary Outcomes (5)

• Adverse Events

  2 months

• Total doses of opioids

  24 hours

• Time to the first dose of opioids

  24 hours

• Post-mastectomy pain syndrome

  2 months

• Quality of life

  2 months

Study Arms (2)

Thoracic Paravertebral Block

EXPERIMENTAL

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.

Procedure: Thoracic Paravertebral Block

Surgical Wound Infiltration

ACTIVE COMPARATOR

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.

Procedure: Surgical Wound Infiltration

Interventions

Thoracic Paravertebral Block PROCEDURE

Thoracic paravertebral block at T3 level with bupivacaine 0.5%, dosis 1.5mg/Kg

Thoracic Paravertebral Block

Surgical Wound Infiltration PROCEDURE

Surgical wound infiltration on the skin and subcutaneous tissue in surgical area with bipivacaine 0.5%, dosis 1.5mg/kg

Surgical Wound Infiltration

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women older than 18 years.
• 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.
• Willingness to participate in the study during the follow-up period.

You may not qualify if:

• Metastatic breast carcinoma; tumor involvement of contra lateral breast or armpit determined by clinical or paraclinical studies.
• Medical History of coagulopathy.
• Consumption of anticoagulants.
• Contraindication to NSAIDs or opioids.
• Allergy to local anesthetics of amide type.
• Infection a interventions sites (paravertebral block or area affected breast surgical wound)
• Pregnancy and lactation.
• BMI\>35.
• Parkinson's disease, Alzheimer's disease or other diseases that affect the mental or motor sphere.
• Double mastectomy or mastectomy history of previous ipsilateral to the current episode.
• Preoperative risk classification ASA IV-V.

Sponsors & Collaborators

• Instituto de Cancerología S.A.: lead

Study Sites (1)

Instituto de Cancerología IDC Las Américas

Medellín, Antioquia, Colombia

Location

Related Publications (2)

• 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.

  PMID: 15562083 RESULT

• 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.

  PMID: 18292452 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Agnosia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fernando Herazo, MD, MSc

  Instituto de Cancerología IDC Las Américas

  PRINCIPAL INVESTIGATOR

• Hector I García, MD, MPH, MSc

  Instituto de Cancerología IDC Las Américas

  PRINCIPAL INVESTIGATOR

• Jorge A Egurrola, MD

  Instituto de Cancerología IDC Las Américas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2015
• First Posted: November 20, 2015
• Study Start: November 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 26, 2016

Record last verified: 2016-12

Locations

CO (1)