Postoperative PainNCT05276440
Effects of Regional Anesthesia Following Mastectomy
An observational study of Postoperative Pain, run by Koc University Hospital.
Trial summary
Patients of breast surgery dated between April 2016 and March 2021 will be scanned in three groups; solely induced general anesthesia, general anesthesia induced with Erector Spinae Plane Block, and general anesthesia induced with Rhomboid Block. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain
- How many people
- 182 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 31 Mar 2021
- 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 to 75 years
- All sexes
- Adult, Older adult
Study population: Breast surgery patients
Who may be able to join
- Patients underwent breast surgery under general anesthesia with or without one of the blocks; Erector Spinae Plane Block and Rhomboid Block.
Who cannot join
- Incomplete patient forms.
About this study
Official title: Effects of Regional Anesthesia on Postoperative Recovery and Opioid Consumption Following Mastectomy: A Retrospective Study
Patients of breast surgery dated between April 2016 and March 2021 will be scanned in three groups; solely induced general anesthesia, general anesthesia induced with Erector Spinae Plane Block, and general anesthesia induced with Rhomboid Block.
The investigators aimed to retrospectively compare the effectiveness of regional anesthesia techniques used in the clinic for postoperative recovery and opioid consumption in patients who underwent breast surgery.
- Conditions
- Postoperative Pain
- Medical subject headings
- Pain, Postoperative
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 |
|---|---|---|
| General Anesthesia | Not described | |
| Erector Spinae Plane Block | Not described | |
| Rhomboid Block | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid consumption retrieved from the patient records
Measured: up to 24 hours
Length of hospital stay
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start1 Apr 2016
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koc University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seçil Çetin, Koc University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276440
- Sponsor's protocol ID
- KocUniversity
- Status last verified
- Mar 2022
- First submitted
- 19 Feb 2022
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Regional Anesthesia on Postoperative Recovery and Opioid Consumption Following Mastectomy: A Retrospective Study
- ClinicalTrials.gov ID
- NCT05276440
- Acronym / sponsor ID
- KocUniversity
- Conditions
- Postoperative Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Koc University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 11 Mar 2022 (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.
Patients of breast surgery dated between April 2016 and March 2021 will be scanned in three groups; solely induced general anesthesia, general anesthesia induced with Erector Spinae Plane Block, and general anesthesia induced with Rhomboid Block.
The investigators aimed to retrospectively compare the effectiveness of regional anesthesia techniques used in the clinic for postoperative recovery and opioid consumption in patients who underwent breast surgery.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia | – | – |
| Erector Spinae Plane Block | – | – |
| Rhomboid Block | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Breast surgery patients
Key inclusion criteria (1 listed)
- Patients underwent breast surgery under general anesthesia with or without one of the blocks; Erector Spinae Plane Block and Rhomboid Block.
Key exclusion criteria (1 listed)
- Incomplete patient forms.
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
Total opioid consumption retrieved from the patient records
Time frame: up to 24 hours
Length of hospital stay
Time frame: up to 1 week
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 11 Mar 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by Koc University Hospital.
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 1 inclusion and 1 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 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Total opioid consumption retrieved from the patient records (time frame: up to 24 hours). The study lists 2 primary outcomes in all. 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 11 Mar 2022.