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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.

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
NameTimeMethod
Postoperative fentanyl consumptionat postoperative 48 hours

Cumulative fentanyl consumption within postoperative 24-48 hours

Secondary Outcome Measures
NameTimeMethod
Intraoperative fentanyl useIntraoperation

Dosage of intraoperative fentanyl usage in micrograms

Percentage of patients presenting with opioid-related adverse effectsWithin 48 hours

adverse effects include postoperative nausea, vomiting, dizziness, pruritus

Cost effectiveness analysisWithin 48 hours

Cost of adding nerve block and postoperative pain score

Postoperative pain score at restPostoperative 24 hour (at ward)

Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable)

First time to fentanyl requirement by IV PCAWithin 24 hours

time to require fentanyl patient-controlled intravenous analgesia

Length of hospital stayFrom preoperative admission until hospital discharge

Number of hospital admission days

Percentage of patients presenting with nerve block complicationsWithin 48 hours

nerve block complications include pneumothorax, hypotension, local anesthetic systemic toxicity, Horner syndrome

Postoperative pain score on shoulder movementPostoperative second day (at ward)

Numeric rating score ((0= no pain, 10= worst pain imaginable)

Patient's satisfaction scale scoreAt 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

Faculty of Medicine Siriraj Hospital, Mahidol University
🇹🇭Bangkok Noi, Bangkok, Thailand
Suwimon Tangwiwat, M.D
Contact
(66)81-645-6167
stangwiwat@yahoo.com

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