Analgesic Effect of Adding Thoracic Paravertebral Nerve Blocks to Modified PEC Block in Breast Cancer Surgery

Mahidol University

Status: Unknown

Conditions: Breast Cancer Female; Pain, Postoperative

Treatments: Procedure: GA with ETT; Procedure: Thoracic paravertebral block under ultrasound guidance; Procedure: Intraoperative modified PEC block

Study type: Interventional

Funder types: Other

Identifiers

NCT04056676

SI 475/2019

Details and patient eligibility

About

To compare efficacy and safety of adding thoracic paravertebral nerve blocks to modified PEC block versus modified PEC block only in breast cancer surgery. This study evaluate systemic opioid requirement in 48 hours in primary outcome and the analgesic profile ( pain score at rest and on shoulder movement), opioid-related side effects and nerve blocks complications.

Full description

Regional anesthesia has been used and studied extensively in breast surgery as an opioid-sparing strategy, with block of the intercostal supply by thoracic paravertebral block (TPVB) becoming a popular technique.

This prospective randomized controlled trial is aimed to study the proper regional nerve block technique to reach the postoperative opioid-free requirement modality for breast cancer surgery.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American Society of Anesthesiologists (ASA) grade I-III
• Aged ≥ 18-80 years old
• Elective unilateral total mastectomy with sentinel lymph node biopsy or lymph node dissection

Exclusion criteria

• Patient refusal
• Language barrier or inability to communicate with the operating team
• Allergy to local anesthetic
• Bleeding disorder
• Previous breast surgery or thoracic radiation therapy
• BMI ≥ 30
• Patient who can not understand the proper use of intravenous patient-controlled analgesia machine or who has the problem with communication
• Chronic pain patient

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Intraoperative modified PEC block only

Active Comparator group

Description:

Intraoperative modified PEC block with 0.5% bupivacaine 20 ml plus adrenaline 100 ug by surgeon

Treatment:

Procedure: Intraoperative modified PEC block

Procedure: GA with ETT

Adding preoperative thoracic paravertebral nerve block

Experimental group

Description:

Preoperative thoracic paravertebral nerve block with 0.5% bupivacaine 20 ml plus adrenaline 100 ug and intraoperative modified PEC block with 0.5% bupivacaine 20 ml plus adrenaline 100 ug by surgeon

Treatment:

Procedure: Intraoperative modified PEC block

Procedure: Thoracic paravertebral block under ultrasound guidance

Procedure: GA with ETT