Evaluation of Persistent Postsurgical Pain After Breast Surgery With a Pectoral Nerves Block (Pecs) Type II
Primary Purpose
Chronic Post-Procedural Pain, Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Chronic pain evaluation
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Post-Procedural Pain
Eligibility Criteria
Inclusion Criteria:
- participated in the Large-scale Prospective Double-blind Randomized Controlled Trial of Pecs II Block for Breast Surgery (NCT02544282)
Exclusion Criteria:
- patient refusal
Sites / Locations
- GZA Sint Augustinus
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Pecs group (study group)
Control group (placebo group)
Arm Description
Chronic pain assessment with study questionnaire
Chronic pain assessment with study questionnaire
Outcomes
Primary Outcome Measures
Chronic post- procedural pain evaluation through questionaire
Evaluation of the chronic post procedural pain in breast surgery under general anesthesia with a pecs or placebo block
Secondary Outcome Measures
Full Information
NCT ID
NCT03116048
First Posted
April 3, 2017
Last Updated
February 13, 2019
Sponsor
GZA Ziekenhuizen Campus Sint-Augustinus
1. Study Identification
Unique Protocol Identification Number
NCT03116048
Brief Title
Evaluation of Persistent Postsurgical Pain After Breast Surgery With a Pectoral Nerves Block (Pecs) Type II
Official Title
Evaluation of Persistent Postsurgical Pain After Breast Surgery With a Pectoral Nerves Block (Pecs) Type II: a Prospective Follow-up After a Prospective Double Blind Placebo-controlled Randomized Controlled Trail
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
May 2, 2017 (Actual)
Primary Completion Date
June 12, 2017 (Actual)
Study Completion Date
April 24, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GZA Ziekenhuizen Campus Sint-Augustinus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background and objectives The Pectoral Nerves Block (Pecs) Type II is a regional anesthesia technique that provides post-surgical pain relief for patients undergoing breast surgery. Post-procedural pain relief is known to diminish persistent pain. In this prospective follow-up, the investigators evaluated whether the Pecs II block, compared to placebo, is effective in reducing persistent post-procedural pain after breast cancer surgery in female patients.
Patients and methods 140 breast cancer stage 1-3 patients undergoing mastectomy or tumorectomy with sentinel node or axillary node dissection under general anesthesia were randomized to receive a Pecs block (levobupivacaine 0.25%) or placebo (saline 0.9%). Patients were invited between 9 and 31 months after surgery to complete a persistent postsurgical pain survey.
Detailed Description
Breast cancer is the most common cancer in women. For breast cancer patients, surgery is the most effective therapeutic intervention. Up to two thirds of female patients undergoing breast cancer surgery develop chronic post-procedural pain. This can be best understood by the fact that chronic post-procedural pain is strongly associated with acute post-procedural pain and that even minimal breast surgery can result in significant post-procedural pain.
Regional anesthesia techniques can improve acute and chronic post-procedural pain outcomes. In the prospective double blind placebo-controlled randomized controlled trial, the investigators found that the pectoral nerves (Pecs) block type II, as described by Blanco et al., provides reliable and effective post-procedural analgesia for patients undergoing breast surgery.
In this prospective follow-up, the investigators evaluate whether the Pecs II block is effective in reducing chronic post-procedural pain in female adult patients undergoing breast cancer surgery compared to placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Post-Procedural Pain, Breast Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pecs group (study group)
Arm Type
Other
Arm Description
Chronic pain assessment with study questionnaire
Arm Title
Control group (placebo group)
Arm Type
Other
Arm Description
Chronic pain assessment with study questionnaire
Intervention Type
Other
Intervention Name(s)
Chronic pain evaluation
Intervention Description
Chronic pain assessment with study questionnaire
Primary Outcome Measure Information:
Title
Chronic post- procedural pain evaluation through questionaire
Description
Evaluation of the chronic post procedural pain in breast surgery under general anesthesia with a pecs or placebo block
Time Frame
1-3 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
participated in the Large-scale Prospective Double-blind Randomized Controlled Trial of Pecs II Block for Breast Surgery (NCT02544282)
Exclusion Criteria:
patient refusal
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Van Houwe, MD
Organizational Affiliation
GZA Ziekenhuizen Campus Sint-Augustinus
Official's Role
Study Director
Facility Information:
Facility Name
GZA Sint Augustinus
City
Wilrijk
State/Province
Antwerpen
ZIP/Postal Code
2610
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25220842
Citation
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Results Reference
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PubMed Identifier
17457156
Citation
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Results Reference
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PubMed Identifier
16942948
Citation
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Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Citation
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Citation
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Citation
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Results Reference
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Evaluation of Persistent Postsurgical Pain After Breast Surgery With a Pectoral Nerves Block (Pecs) Type II
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