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Clinical Trials/NCT04056676
NCT04056676
Unknown
Not Applicable

Analgesic Effect of Adding Thoracic Paravertebral Nerve Blocks to Modified PEC Block in Breast Cancer Surgery, Prospective Randomized Controlled Study

Mahidol University1 site in 1 country100 target enrollmentAugust 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer Female
Sponsor
Mahidol University
Enrollment
100
Locations
1
Primary Endpoint
Postoperative fentanyl consumption
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2019
End Date
March 1, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Suwimon Tangwiwat

Assistant professor, Department of Anesthesiology

Mahidol University

Eligibility Criteria

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
  • Patient who can not understand the proper use of intravenous patient-controlled analgesia machine or who has the problem with communication
  • Chronic pain patient

Outcomes

Primary Outcomes

Postoperative fentanyl consumption

Time Frame: at postoperative 48 hours

Cumulative fentanyl consumption within postoperative 24-48 hours

Secondary Outcomes

  • Intraoperative fentanyl use(Intraoperation)
  • Percentage of patients presenting with opioid-related adverse effects(Within 48 hours)
  • Cost effectiveness analysis(Within 48 hours)
  • Postoperative pain score at rest(Postoperative 24 hour (at ward))
  • First time to fentanyl requirement by IV PCA(Within 24 hours)
  • Length of hospital stay(From preoperative admission until hospital discharge)
  • Percentage of patients presenting with nerve block complications(Within 48 hours)
  • Postoperative pain score on shoulder movement(Postoperative second day (at ward))
  • Patient's satisfaction scale score(At postoperative 48 hours)

Study Sites (1)

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