- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06718868
Evaluation of the Effect of Pectoral Nerve Block II on Acute and Chronic Pain in Patients Undergoing Oncological Breast Surgery
The aim of this observational study is to evaluate the effect of Pectoral Nerve Block II (PECSII) on the development of pain in the acute and chronic periods in female patients over the age of 18 who underwent oncological breast surgery. The main questions it aims to answer are:
Is PECSII blockade applied to patients undergoing oncological breast surgery effective on acute pain scores compared to the non-blockade group? Is there a difference between the group with block and the group without block in terms of the development of chronic pain in the evaluation made at the 3rd month after surgery? The analgesia method applied to the patients will be recorded in the patient files and acute and chronic pain scores will be evaluated. Chronic pain score evaluation will be made by telephone survey.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients who will be operated under general anesthesia
- ASA score I-II-III patients
- Non-pregnant patients
- Patients who agreed to participate in the study
Exclusion Criteria:
- Patients with coagulopathy
- Patients who underwent bilateral mastectomy
- Patients with chest wall anomalies
- Patients with neuropathic pain before surgery
- Patients who did not agree to participate in the study
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Group 1
Patients in Group 1 were defined as those who received PECSII Block in addition to intravenous analgesia.
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Group 2
Patients in Group 2 were defined as patients who received intravenous analgesia only.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Evaluation of the effect of PECSII block on the development of chronic pain in patients undergoing oncological breast surgery
Time Frame: 3 months
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Female patients over 18 years of age, non-pregnant, cooperative, and who agreed to participate in the study, who underwent oncological breast surgery, were contacted by phone in the 3rd month post-operation and evaluated for the development of chronic pain using the PAIN Detect pain scale.Only patients who received routine intravenous analgesia and patients who received PECSII block in addition to routine intravenous analgesia were included in the study.
The patients were divided into two groups.
The development of chronic pain in the block group was compared with the patients in the non-block group.
The surgical technique applied to the patients was recorded from the patient files.
The relationship between surgical technique and pain occurrence was evaluated.
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3 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Serap Karacalar, Prof., Prof. Dr. Cemil Tascioglu Education and Research Hospital
- Principal Investigator: İrem Erkan, M.D., Prof. Dr. Cemil Tascioglu Education and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-48670771-514.99-232052317
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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