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

Primary Purpose

Breast Cancer Female, Pain, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Thoracic paravertebral block under ultrasound guidance
Intraoperative modified PEC block
GA with ETT
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer Female focused on measuring Postoperative pain, Thoracic paravertebral block, Modified PEC block, Breast cancer, Total mastectomy with sentinel lymph node clearance

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Faculty of Medicine Siriraj Hospital, Mahidol UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Intraoperative modified PEC block only

Adding preoperative thoracic paravertebral nerve block

Arm Description

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

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

Outcomes

Primary Outcome Measures

Postoperative fentanyl consumption
Cumulative fentanyl consumption within postoperative 24 hours
Postoperative fentanyl consumption
Cumulative fentanyl consumption within postoperative 24-48 hours

Secondary Outcome Measures

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

Full Information

First Posted
August 8, 2019
Last Updated
May 21, 2021
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT04056676
Brief Title
Analgesic Effect of Adding Thoracic Paravertebral Nerve Blocks to Modified PEC Block in Breast Cancer Surgery
Official Title
Analgesic Effect of Adding Thoracic Paravertebral Nerve Blocks to Modified PEC Block in Breast Cancer Surgery, Prospective Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
March 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female, Pain, Postoperative
Keywords
Postoperative pain, Thoracic paravertebral block, Modified PEC block, Breast cancer, Total mastectomy with sentinel lymph node clearance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
group A Intraoperative modified PEC block only group B Preoperative thoracic paravertebral block plus intraoperative modified PEC block
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Randomized group of patient is identified and sealed in envelope. There is not written group in anesthetic record. Postoperative outcomes are assessed by Acute Pain Service nurse or a resident (co-investigator who blinds to the technique).
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intraoperative modified PEC block only
Arm Type
Active Comparator
Arm Description
Intraoperative modified PEC block with 0.5% bupivacaine 20 ml plus adrenaline 100 ug by surgeon
Arm Title
Adding preoperative thoracic paravertebral nerve block
Arm Type
Experimental
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Thoracic paravertebral block under ultrasound guidance
Other Intervention Name(s)
USG-TPVB
Intervention Description
Ultrasound-guided thoracic paravertebral blocks in T2, T4 level
Intervention Type
Procedure
Intervention Name(s)
Intraoperative modified PEC block
Other Intervention Name(s)
Modified PEC block
Intervention Description
Pectoral nerve block by surgeon under direct vision after total mastectomy
Intervention Type
Procedure
Intervention Name(s)
GA with ETT
Intervention Description
General anesthesia with endotracheal intubation
Primary Outcome Measure Information:
Title
Postoperative fentanyl consumption
Description
Cumulative fentanyl consumption within postoperative 24 hours
Time Frame
at postoperative 24 hours
Title
Postoperative fentanyl consumption
Description
Cumulative fentanyl consumption within postoperative 24-48 hours
Time Frame
at postoperative 48 hours
Secondary Outcome Measure Information:
Title
Intraoperative fentanyl use
Description
Dosage of intraoperative fentanyl usage in micrograms
Time Frame
Intraoperation
Title
Postoperative pain score at rest
Description
Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable)
Time Frame
at postoperative 0 hour (PACU arrival)
Title
Postoperative pain score at rest
Description
Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable)
Time Frame
at postoperative 30 min (in PACU)
Title
Postoperative pain score at rest
Description
Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable)
Time Frame
at postoperative 1 hour (in PACU)
Title
Postoperative pain score at rest
Description
Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable)
Time Frame
Postoperative 6 hour (at ward)
Title
Postoperative pain score at rest
Description
Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable)
Time Frame
Postoperative 12 hour (at ward)
Title
Postoperative pain score at rest
Description
Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable)
Time Frame
Postoperative 18 hour (at ward)
Title
Postoperative pain score at rest
Description
Numeric rating score 0-10 (0= no pain, 10= worst pain imaginable)
Time Frame
Postoperative 24 hour (at ward)
Title
Postoperative pain score on shoulder movement
Description
Numeric rating score ((0= no pain, 10= worst pain imaginable)
Time Frame
Postoperative 1 hour (at PACU)
Title
Postoperative pain score on shoulder movement
Description
Numeric rating score ((0= no pain, 10= worst pain imaginable)
Time Frame
Postoperative first day (at ward)
Title
Postoperative pain score on shoulder movement
Description
Numeric rating score ((0= no pain, 10= worst pain imaginable)
Time Frame
Postoperative second day (at ward)
Title
First time to fentanyl requirement by IV PCA
Description
time to require fentanyl patient-controlled intravenous analgesia
Time Frame
Within 24 hours
Title
Percentage of patients presenting with opioid-related adverse effects
Description
adverse effects include postoperative nausea, vomiting, dizziness, pruritus
Time Frame
Within 48 hours
Title
Percentage of patients presenting with nerve block complications
Description
nerve block complications include pneumothorax, hypotension, local anesthetic systemic toxicity, Horner syndrome
Time Frame
Within 48 hours
Title
Length of hospital stay
Description
Number of hospital admission days
Time Frame
From preoperative admission until hospital discharge
Title
Patient's satisfaction scale score
Description
Satisfaction scale score 0-10 (0= highly unsatisfied, 10= highly satisfied)
Time Frame
At postoperative 48 hours
Title
Cost effectiveness analysis
Description
Cost of adding nerve block and postoperative pain score
Time Frame
Within 48 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suwimon Tangwiwat, MD
Phone
66816456167
Email
stangwiwat@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suwimon Tangwiwat, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Siriraj Hospital, Mahidol University
City
Bangkok Noi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suwimon Tangwiwat, M.D
Phone
(66)81-645-6167
Email
stangwiwat@yahoo.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
30640648
Citation
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Results Reference
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PubMed Identifier
28820803
Citation
Woodworth GE, Ivie RMJ, Nelson SM, Walker CM, Maniker RB. Perioperative Breast Analgesia: A Qualitative Review of Anatomy and Regional Techniques. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):609-631. doi: 10.1097/AAP.0000000000000641.
Results Reference
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PubMed Identifier
28601480
Citation
Wynne R, Lui N, Tytler K, Koffsovitz C, Kirwa V, Riedel B, Ryan S. The Trajectory of Postoperative Pain Following Mastectomy with and without Paravertebral Block. Pain Manag Nurs. 2017 Aug;18(4):234-242. doi: 10.1016/j.pmn.2017.03.003. Epub 2017 Jun 7.
Results Reference
background
PubMed Identifier
28890559
Citation
Syal K, Chandel A. Comparison of the post-operative analgesic effect of paravertebral block, pectoral nerve block and local infiltration in patients undergoing modified radical mastectomy: A randomised double-blind trial. Indian J Anaesth. 2017 Aug;61(8):643-648. doi: 10.4103/ija.IJA_81_17.
Results Reference
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PubMed Identifier
26431130
Citation
Terkawi AS, Tsang S, Sessler DI, Terkawi RS, Nunemaker MS, Durieux ME, Shilling A. Improving Analgesic Efficacy and Safety of Thoracic Paravertebral Block for Breast Surgery: A Mixed-Effects Meta-Analysis. Pain Physician. 2015 Sep-Oct;18(5):E757-80.
Results Reference
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PubMed Identifier
10825328
Citation
Klein SM, Bergh A, Steele SM, Georgiade GS, Greengrass RA. Thoracic paravertebral block for breast surgery. Anesth Analg. 2000 Jun;90(6):1402-5. doi: 10.1097/00000539-200006000-00026.
Results Reference
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PubMed Identifier
25376971
Citation
Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.
Results Reference
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Analgesic Effect of Adding Thoracic Paravertebral Nerve Blocks to Modified PEC Block in Breast Cancer Surgery

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