Breast CarcinomaNCT06718868
Evaluation of the Effect of Pectoral Nerve Block II on Acute and Chronic Pain in Patients Undergoing Oncological Breast Surgery
An observational study of Breast Carcinoma and Chronic Pain, run by Irem Erkan at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Carcinoma, Chronic Pain
- Type of treatment
- Injection or infusion
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2024to 15 Aug 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 128 patients who met the inclusion criteria were included in the study.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof. Dr. Cemil Tascıoglu Education and Research Hospital
Istanbul
About this study
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.
- Conditions
- Breast Carcinoma, Chronic Pain
- Keywords
- Oncological breast surgery, PECS II Block, chronic pain, acute pain
- Medical subject headings
- Breast Neoplasms, Chronic Pain, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the effect of PECSII block on the development of chronic pain in patients undergoing oncological breast surgery
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start5 Jan 2024
- Primary completion15 Mar 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 128 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Irem Erkan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Irem Erkan, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Investigators
- Serap Karacalar, Prof., Study director, Prof. Dr. Cemil Tascioglu Education and Research Hospitalİrem Erkan, M.D., Principal investigator, Prof. Dr. Cemil Tascioglu Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718868
- Sponsor's protocol ID
- E-48670771-514.99-232052317
- Status last verified
- Nov 2024
- First submitted
- 2 Dec 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Pectoral Nerve Block II on Acute and Chronic Pain in Patients Undergoing Oncological Breast Surgery
- ClinicalTrials.gov ID
- NCT06718868
- Acronym / sponsor ID
- E-48670771-514.99-232052317
- Conditions
- Breast Carcinoma, Chronic Pain
- Keywords
- Oncological breast surgery, PECS II Block, chronic pain, acute pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Irem ErkanUniversity, hospital or other
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 128 patients who met the inclusion criteria were included in the study.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serap Karacalar, Prof. study director
Prof. Dr. Cemil Tascioglu Education and Research Hospital
İrem Erkan, M.D. principal investigator
Prof. Dr. Cemil Tascioglu Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Carcinoma and Chronic Pain, run by Irem Erkan at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the effect of PECSII block on the development of chronic pain in patients undergoing oncological breast surgery (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.