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

Breast Cancer Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02609321
• Other study ID #: IDC0001
• Status: Completed
• Phase: Phase 3
• First received: September 14, 2015
• Last updated: December 23, 2016
• Start date: November 2015
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Instituto de Cancerología S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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%.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Women older than 18 years.

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:

1. Metastatic breast carcinoma; tumor involvement of contra lateral breast or armpit determined by clinical or paraclinical studies.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Colombia	Instituto de Cancerología IDC Las Américas	Medellín	Antioquia

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Cancerología S.A.

Country where clinical trial is conducted

Colombia, 

References & 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- — View Citation

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. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Adverse Events	Compare the frequency and severity of adverse events in both groups	2 months	Yes
Secondary	Total doses of opioids	Compare the total dose of self-administered opioids analgesics for the first 24 hours	24 hours	Yes
Secondary	Time to the first dose of opioids	Compare the time to first dose of opioids analgesics in both groups	24 hours	Yes
Secondary	Post-mastectomy pain syndrome	Compare the frequency of diagnosis of Post-mastectomy pain syndrome (SDP) two months after breast surgery in both groups	2 months	No
Secondary	Quality of life	Estimate the changes in the quality of life of patients after two months after breast surgery in both groups	2 months	No