AnalgesiaNCT05911373
Serratus Plane Block Versus Serratus Plane Block Plus Parasternal Block Combination for Breast Surgery
A study testing group serratus plan block and group serratus and parasternal plan block in people with Analgesia and Cancer, Breast, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Mastectomy is a technique often used in breast cancer surgery. Patients experience moderate to severe pain postoperatively after this procedure. Various plane blocks, NSAIDs, and opioid analgesics can be administered to these patients as components of multimodal analgesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Analgesia, Cancer, Breast
- What is being tested?
- group serratus plan block and group serratus and parasternal plan block
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jun 2023to 15 Jan 2024
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologist's physiologic state I-III patients
- To undergo Mastectomy Surgery
- Being between the ages of 18-65 years
Who cannot join
- Having a known heart, kidney, liver or hematological disease
- Having a history of peptic ulcer, gastrointestinal bleeding, allergy, chronic pain
- Routine analgesic use and history of analgesic use in the last 24 hours
- Not willing to participate in the study
- Uncooperative patients who have coagulopathy or use anticoagulant drugs
- To be allergic to one of the drugs to be used
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serratus Plane Block Versus Serratus Plane Block Plus Parasternal Block on Postoperative Opioid Consumption and Dermatomal Analyses for Breast Surgery
Mastectomy is a technique often used in breast cancer surgery. Patients experience moderate to severe pain postoperatively after this procedure. Various plane blocks, NSAIDs, and opioid analgesics can be administered to these patients as components of multimodal analgesia. In the the study, the investigators aimed to evaluate the analgesic effects of the serratus plane block, the parasternal block added to the serratus plane block, and the dermatomal differences.
- Conditions
- Analgesia, Cancer, Breast
- Being tested
- group serratus plan block, group serratus and parasternal plan block
- Medical subject headings
- Agnosia, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group serratus plan blockOther
preoperativelly, Superficial Serratus Block performed with 30 ml %0.25 Bupivacaine and Parasternal Block performed with 10 ml saline
group serratus and parasternal plan blockOther
preoperativelly, Superficial Serratus Block performed with 30 ml %0.25 Bupivacaine and Parasternal Block performed with 10 ml %0.25 Bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| group serratus | Placebo comparator | preoperative superficial serratus block with local anaesthetics and parasternal block with saline Receives: Other: group serratus plan block |
| group serratus and parasternal | Active comparator | preoperative superficial serratus block and parasternal block with local anaesthetics Receives: Other: group serratus and parasternal plan block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid consumption
First 24 hours total fentanyl consumption with patient controlled analgesia
Measured: first 24 hours
Secondary outcomes (2)
Visual analog pain score
Post operative pain will be evaluated with a Visual Analogue Scale (between 0-10; 0: no pain, 10:worst pain) score
Measured: First 24 hours
Sensory Assessment
Sensory Assessment will be performed on patients following the block procedure with pinprick test.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start21 Jun 2023
- Primary completion1 Jan 2024
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Ahiskalioglu, Ataturk University
- Investigators
- Hüsnü Kürşad, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911373
- Sponsor's protocol ID
- ataunibreastanalgesia
- Status last verified
- Mar 2024
- First submitted
- 30 May 2023
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hu NQ, He QQ, Qian L, Zhu JH. Efficacy of Ultrasound-Guided Serratus Anterior Plane Block for Postoperative Analgesia in Patients Undergoing Breast Surgery: A Systematic Review and Meta-Analysis of Randomised Controlled Trials. Pain Res Manag. 2021 Oct 25;2021:7849623. doi: 10.1155/2021/7849623. eCollection 2021.
PubMed 34733377Piraccini E, Biondi G, Corso RM, Maitan S. The use of rhomboid intercostal block, parasternal block and erector spinae plane block for breast surgery. J Clin Anesth. 2020 Feb;59:10. doi: 10.1016/j.jclinane.2019.06.004. Epub 2019 Jun 6. No abstract available.
PubMed 31176954
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serratus Plane Block Versus Serratus Plane Block Plus Parasternal Block on Postoperative Opioid Consumption and Dermatomal Analyses for Breast Surgery
- ClinicalTrials.gov ID
- NCT05911373
- Acronym / sponsor ID
- ataunibreastanalgesia
- Conditions
- Analgesia, Cancer, Breast
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 22 Jun 2023 (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.
Mastectomy is a technique often used in breast cancer surgery. Patients experience moderate to severe pain postoperatively after this procedure. Various plane blocks, NSAIDs, and opioid analgesics can be administered to these patients as components of multimodal analgesia. In the the study, the investigators aimed to evaluate the analgesic effects of the serratus plane block, the parasternal block added to the serratus plane block, and the dermatomal differences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group serratus | Placebo comparator | Other: group serratus plan blockpreoperative superficial serratus block with local anaesthetics and parasternal block with saline |
| group serratus and parasternal | Active comparator | Other: group serratus and parasternal plan blockpreoperative superficial serratus block and parasternal block with local anaesthetics |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologist's physiologic state I-III patients
- To undergo Mastectomy Surgery
- Being between the ages of 18-65 years
Key exclusion criteria (6 listed)
- Having a known heart, kidney, liver or hematological disease
- Having a history of peptic ulcer, gastrointestinal bleeding, allergy, chronic pain
- Routine analgesic use and history of analgesic use in the last 24 hours
- Not willing to participate in the study
- Uncooperative patients who have coagulopathy or use anticoagulant drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| group serratus plan blockpreoperativelly, Superficial Serratus Block performed with 30 ml %0.25 Bupivacaine and Parasternal Block performed with 10 ml saline | Other | group serratus |
| group serratus and parasternal plan blockpreoperativelly, Superficial Serratus Block performed with 30 ml %0.25 Bupivacaine and Parasternal Block performed with 10 ml %0.25 Bupivacaine | Other | group serratus and parasternal |
Primary outcome
Postoperative opioid consumption
Time frame: first 24 hours
First 24 hours total fentanyl consumption with patient controlled analgesia
2 secondary outcomes
Visual analog pain score
Time frame: First 24 hours
Sensory Assessment
Time frame: 24 hours
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 1 Apr 2024.
- Background: PubMed 34733377Hu NQ, He QQ, Qian L, Zhu JH. Efficacy of Ultrasound-Guided Serratus Anterior Plane Block for Postoperative Analgesia in Patients Undergoing Breast Surgery: A Systematic Review and Meta-Analysis of Randomised Controlled Trials. Pain Res Manag. 2021 Oct 25;2021:7849623. doi: 10.1155/2021/7849623. eCollection 2021.
- Background: PubMed 31176954Piraccini E, Biondi G, Corso RM, Maitan S. The use of rhomboid intercostal block, parasternal block and erector spinae plane block for breast surgery. J Clin Anesth. 2020 Feb;59:10. doi: 10.1016/j.jclinane.2019.06.004. Epub 2019 Jun 6. No abstract available.
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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.
Hüsnü Kürşad study director
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing group serratus plan block and group serratus and parasternal plan block in people with Analgesia and Cancer, Breast, run by Ataturk University 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 3 inclusion and 6 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 1 Apr 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. Some participants in this study may receive a placebo. 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?
Postoperative opioid consumption (time frame: first 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05911373, which also lists 2 linked publications.
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 1 Apr 2024.