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

Not Applicable

• Conditions: Breast Cancer Female; Pain, Postoperative

• Registration Number: NCT04056676
• Lead Sponsor: Mahidol University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2019-08-01
• Study First Submitted: 2019-08-08
• Study First Submitted QC: 2019-08-12
• Study First Posted: 2019-08-14
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-21
• Last Update Posted: 2021-05-24
• Primary Completion: 2021-12-01
• Study Completion: 2022-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative fentanyl consumption	at postoperative 48 hours	Cumulative fentanyl consumption within postoperative 24-48 hours

Secondary Outcome Measures

Name	Time	Method
Intraoperative fentanyl use	Intraoperation	Dosage of intraoperative fentanyl usage in micrograms
Percentage of patients presenting with opioid-related adverse effects	Within 48 hours	adverse effects include postoperative nausea, vomiting, dizziness, pruritus
Cost effectiveness analysis	Within 48 hours	Cost of adding nerve block and postoperative pain score
Postoperative pain score at rest	Postoperative 24 hour (at ward)	Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable)
First time to fentanyl requirement by IV PCA	Within 24 hours	time to require fentanyl patient-controlled intravenous analgesia
Length of hospital stay	From preoperative admission until hospital discharge	Number of hospital admission days
Percentage of patients presenting with nerve block complications	Within 48 hours	nerve block complications include pneumothorax, hypotension, local anesthetic systemic toxicity, Horner syndrome
Postoperative pain score on shoulder movement	Postoperative second day (at ward)	Numeric rating score ((0= no pain, 10= worst pain imaginable)
Patient's satisfaction scale score	At postoperative 48 hours	Satisfaction scale score 0-10 (0= highly unsatisfied, 10= highly satisfied)

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok Noi, Bangkok, Thailand