Evaluation of the Effect of Pectoral Nerve Block II on Acute and Chronic Pain in Patients Undergoing Oncological Breast Surgery

December 2, 2024 updated by: Irem Erkan

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

Completed

Study Type

Observational

Enrollment (Actual)

128

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey
        • Prof. Dr. Cemil Tascıoglu Education and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

128 patients who met the inclusion criteria were included in the study.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group 1
Patients in Group 1 were defined as those who received PECSII Block in addition to intravenous analgesia.
Group 2
Patients in Group 2 were defined as patients who received intravenous analgesia only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the effect of PECSII block on the development of chronic pain in patients undergoing oncological breast surgery
Time Frame: 3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2024

Primary Completion (Actual)

March 15, 2024

Study Completion (Actual)

August 15, 2024

Study Registration Dates

First Submitted

December 2, 2024

First Submitted That Met QC Criteria

December 2, 2024

First Posted (Estimated)

December 5, 2024

Study Record Updates

Last Update Posted (Estimated)

December 5, 2024

Last Update Submitted That Met QC Criteria

December 2, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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