Evaluation of Persistent Postsurgical Pain After Breast Surgery With a Pectoral Nerves Block (Pecs) Type II
NCT03116048 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 121
Last updated 2019-02-15
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.
Conditions
- Chronic Post-Procedural Pain
- Breast Cancer
Interventions
- OTHER
-
Chronic pain evaluation
Chronic pain assessment with study questionnaire
Sponsors & Collaborators
-
GZA Ziekenhuizen Campus Sint-Augustinus
lead OTHER
Principal Investigators
-
Patrick Van Houwe, MD · GZA Ziekenhuizen Campus Sint-Augustinus
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-05-02
- Primary Completion
- 2017-06-12
- Completion
- 2018-04-24
Countries
- Belgium
Study Locations
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