Breast CancerPhase 4NCT04218149
Serratus Plane Block vs Erector Spinae Plane Block on Postoperative Analgesia in Patients Undergoing Unilateral Breast Surgery
A Phase 4 study testing Bupivacaine Injection in people with Breast Cancer and Postoperative Pain, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Interfacial plan blocks are becoming more widely used for postoperative analgesia because of their easier applicability and less risk of complications. In this study, we aimed to compare the effects of serratus plane block (SPB) and erector spinae plane block (ESPB) on postoperative analgesia in patients undergoing… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Postoperative Pain
- What is being tested?
- Bupivacaine Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2019to 1 Oct 2019
- Phase
- Phase 4
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA I-II
- Age: 18 - 65 years
- unilateral breast surgery
Who cannot join
- Does not approve the study
- Pregnant
- Emergency
- ASA III-IV
- History of local anesthetic allergy
- Infection in the block area
Show all 12Show fewer
- Coagulation disorder
- Morbid obesity (body mass index> 40 kg / m²)
- Severe organ failure
- Previous neurological deficit
- Psychiatric disease
- History of chronic pain
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SBÜ Şişli Hamidiye Etfal Eğitim ve Araştırma Hastanesi
Istanbul
About this study
Official title: Comparison of the Effects of Serratus Plane Block and Erector Spinae Plane Block on Postoperative Analgesia in Patients Undergoing Unilateral Breast Surgery
Interfacial plan blocks are becoming more widely used for postoperative analgesia because of their easier applicability and less risk of complications. In this study, we aimed to compare the effects of serratus plane block (SPB) and erector spinae plane block (ESPB) on postoperative analgesia in patients undergoing unilateral breast surgery
- Conditions
- Breast Cancer, Postoperative Pain
- Being tested
- Bupivacaine Injection
- Keywords
- serratus plane block, erector spinae plane block, postoperative analgesia
- Medical subject headings
- Breast Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine InjectionDrug
Block with bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Group S | Active comparator | Serratus plane block with 25 ml %0.25 bupivacaine Receives: Drug: Bupivacaine Injection |
| Grup E | Active comparator | Erector spinae plane block with 25 ml %0.25 bupivacaine Receives: Drug: Bupivacaine Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain score
Visual analog scale (0-10), <4 is adequate analgesia
Measured: Postoperative 24 hours
Postoperative tramadol consumption
Postoperative opiodi consumption with patient controlled analgesia
Measured: Postoperative 24 hours
Rescue analgesic
If VAS score is 4 or more, paracetamol 1 gr is administered
Measured: Postoperative 24 hours
Secondary outcomes (1)
Analgesia time
Time from block performing to first analgesia requirement
Measured: Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start1 May 2019
- Primary completion29 Sep 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerim Şahin, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218149
- Sponsor's protocol ID
- KS01
- Status last verified
- Apr 2019
- First submitted
- 3 Jan 2020
- Last updated
- 31 Jan 2020
- 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 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Serratus Plane Block and Erector Spinae Plane Block on Postoperative Analgesia in Patients Undergoing Unilateral Breast Surgery
- ClinicalTrials.gov ID
- NCT04218149
- Acronym / sponsor ID
- KS01
- Conditions
- Breast Cancer, Postoperative Pain
- Keywords
- serratus plane block, erector spinae plane block, postoperative analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 29 Sep 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 6 Jan 2020 (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.
Interfacial plan blocks are becoming more widely used for postoperative analgesia because of their easier applicability and less risk of complications. In this study, we aimed to compare the effects of serratus plane block (SPB) and erector spinae plane block (ESPB) on postoperative analgesia in patients undergoing unilateral breast surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group S | Active comparator | Drug: Bupivacaine InjectionSerratus plane block with 25 ml %0.25 bupivacaine |
| Grup E | Active comparator | Drug: Bupivacaine InjectionErector spinae plane block with 25 ml %0.25 bupivacaine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I-II
- Age: 18 - 65 years
- unilateral breast surgery
Key exclusion criteria (12 listed)
- Does not approve the study
- Pregnant
- Emergency
- ASA III-IV
- History of local anesthetic allergy
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 |
|---|---|---|
| Bupivacaine InjectionBlock with bupivacaine | Drug | Group S, Grup E |
Primary outcome
Postoperative pain score
Time frame: Postoperative 24 hours
Visual analog scale (0-10), <4 is adequate analgesia
Postoperative tramadol consumption
Time frame: Postoperative 24 hours
Postoperative opiodi consumption with patient controlled analgesia
Rescue analgesic
Time frame: Postoperative 24 hours
If VAS score is 4 or more, paracetamol 1 gr is administered
1 secondary outcome
Analgesia time
Time frame: Procedure
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 31 Jan 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine Injection in people with Breast Cancer and Postoperative Pain, run by Sisli Hamidiye Etfal Training and Research Hospital 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 12 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 31 Jan 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 pain score (time frame: Postoperative 24 hours). The study lists 3 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 31 Jan 2020.