MastectomyNCT04296188
Erector Spina Plane Block vs Serratus Anterior Plane Block for Postoperative Mastectomy Pain
A study testing serratus anterior plane block and erector spina plane block in people with Mastectomy and Pain, Postoperative, run by Tokat Gaziosmanpasa University.
Trial summary
The aim of this study is to compare the efficiency of serratus anterior plane block and erector spina plane block on analgesic consumption, postoperative pain and patient's satisfaction and recovery quality in patients undergoing mastectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Mastectomy, Pain, Postoperative, Recovery Period, Anesthesia
- What is being tested?
- serratus anterior plane block and erector spina plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 18 Mar 2020to 15 Mar 2021
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American society of score anesthesiologist I-II-III
- Elective modified radical mastectomy
- 18-65 years old
Who cannot join
- neurological disease
- coagulopathy disease or using anticoagulants
- non-cooperative
- allergic to one of the drugs used in the study
- recurrent breast cancer
- body mass index is above 35
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Erector Spina Plane Block and Serratus Anterior Plane Block in Patients Undergoing Mastectomy
The aim of this study is to compare the efficiency of serratus anterior plane block and erector spina plane block on analgesic consumption, postoperative pain and patient's satisfaction and recovery quality in patients undergoing mastectomy.
Read the detailed description
Mastectomy may cause severe postoperative pain. There are several analgesic methods for postoperative pain management. Serratus anterior plane (SAP) block is an interfascial plane block which is performed into the fascial plane of serratus anterior muscle. It provides effective analgesia in anterior, posterior and lateral dermatomes of thorax. There are several studies about its analgesic efficacy for mastectomy pain. The erector spina plane (ESP) block is another novel plan block which provides analgesia at multi-dermatomal area of the anterior, posterior, and lateral thoracic and abdominal walls. There are some studies about its effectiveness for postoperative mastectomy pain management. However, according to our best knowledge, there is no literature comparing the efficacy of ESP block and SAP block patients undergoing mastectomy.
- Conditions
- Mastectomy, Pain, Postoperative, Recovery Period, Anesthesia
- Being tested
- serratus anterior plane block, erector spina plane block
- Keywords
- Pain Management, Quality of Healthcare
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serratus anterior plane blockProcedure or surgery
ultrasound guided serratus anterior plane block will be done with % 0.25 bupivacaine.
erector spina plane blockProcedure or surgery
ultrasound guided erector spina plane block will be done with % 0.25 bupivacaine.
| Study group | Role | What they receive |
|---|---|---|
| serratus anterior plane block | Active comparator | The serratus anterior plane block will be performed under ultrasound guidance in the preoperative term. Tramadol will be administered via patient controlled analgesia (PCA) device at 20 mg bolus dose with 10 min. lockout time without basal infusion dose. Receives: Procedure: serratus anterior plane block |
| erector spina plane block | Active comparator | The erector spina plane block will be performed under ultrasound guidance in the preoperative term. Tramadol will be administered via PCA device at 20 mg bolus dose with 10 min. lockout time without basal infusion dose. Receives: Procedure: erector spina plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic consumption
Tramadol dose will be calculated as milligram
Measured: From at the end of surgery (at postoperative 0th hour) to postoperative 24th hours
Secondary outcomes (3)
Postoperative pain intensity
Numeric rating scale which is 0 to 10 will be recorded.In this scale, 0 is no pain, 10 is the worst pain.
Measured: At 0,2,4,6,12,24th hours after surgery
Quality of recovery
Quality of recovery (QoR-40) questionaire will be recorded. The QoR-40 is a questionaire which measures of five dimensions of health: patient support, comfort, emotions, physical independence, and pain on a five-point likert scale. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery)
Measured: At postoperative 24th hours
The number of patients with perioperative side effects
The number of patients with perioperative side effects(emesis, nausea, local anesthetic toxicity, pneumothorax, local hematoma) will be recorded
Measured: From 30 minute before surgery to postoperative 24th hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start18 Mar 2020 (estimated)
- Primary completion27 Feb 2021 (estimated)
- Study completion15 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MastectomyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehtap Gürler Balta, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296188
- Sponsor's protocol ID
- 19KAEK253
- Status last verified
- Mar 2020
- First submitted
- 3 Mar 2020
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Balta MG, Kolukcu V, Sahin AT, Genc A, Suren M, Okan I. Is there a difference in the postoperative quality of recovery and analgesia between erector spinae and serratus anterior plane blocks following modified radical mastectomy: a randomized controlled study. BMC Anesthesiol. 2025 Nov 29;25(1):597. doi: 10.1186/s12871-025-03477-1.
PubMed 41315952
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Erector Spina Plane Block and Serratus Anterior Plane Block in Patients Undergoing Mastectomy
- ClinicalTrials.gov ID
- NCT04296188
- Acronym / sponsor ID
- 19KAEK253
- Conditions
- Mastectomy, Pain, Postoperative, Recovery Period, Anesthesia
- Keywords
- Pain Management, Quality of Healthcare
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 18 Mar 2020 (estimated)
- Primary completion
- 27 Feb 2021 (estimated)
- Study completion
- 15 Mar 2021 (estimated)
- First posted
- 5 Mar 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.
The aim of this study is to compare the efficiency of serratus anterior plane block and erector spina plane block on analgesic consumption, postoperative pain and patient's satisfaction and recovery quality in patients undergoing mastectomy.
Detailed description
Mastectomy may cause severe postoperative pain. There are several analgesic methods for postoperative pain management. Serratus anterior plane (SAP) block is an interfascial plane block which is performed into the fascial plane of serratus anterior muscle. It provides effective analgesia in anterior, posterior and lateral dermatomes of thorax. There are several studies about its analgesic efficacy for mastectomy pain. The erector spina plane (ESP) block is another novel plan block which provides analgesia at multi-dermatomal area of the anterior, posterior, and lateral thoracic and abdominal walls. There are some studies about its effectiveness for postoperative mastectomy pain management. However, according to our best knowledge, there is no literature comparing the efficacy of ESP block and SAP block patients undergoing mastectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| serratus anterior plane block | Active comparator | Procedure: serratus anterior plane blockThe serratus anterior plane block will be performed under ultrasound guidance in the preoperative term. Tramadol will be administered via patient controlled analgesia (PCA) device at 20 mg bolus dose with 10 min. lockout time without basal infusion dose. |
| erector spina plane block | Active comparator | Procedure: erector spina plane blockThe erector spina plane block will be performed under ultrasound guidance in the preoperative term. Tramadol will be administered via PCA device at 20 mg bolus dose with 10 min. lockout time without basal infusion dose. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American society of score anesthesiologist I-II-III
- Elective modified radical mastectomy
- 18-65 years old
Key exclusion criteria (6 listed)
- neurological disease
- coagulopathy disease or using anticoagulants
- non-cooperative
- allergic to one of the drugs used in the study
- recurrent breast cancer
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 |
|---|---|---|
| serratus anterior plane blockultrasound guided serratus anterior plane block will be done with % 0.25 bupivacaine. | Procedure or surgery | serratus anterior plane block |
| erector spina plane blockultrasound guided erector spina plane block will be done with % 0.25 bupivacaine. | Procedure or surgery | erector spina plane block |
Primary outcome
Analgesic consumption
Time frame: From at the end of surgery (at postoperative 0th hour) to postoperative 24th hours
Tramadol dose will be calculated as milligram
3 secondary outcomes
Postoperative pain intensity
Time frame: At 0,2,4,6,12,24th hours after surgery
Quality of recovery
Time frame: At postoperative 24th hours
The number of patients with perioperative side effects
Time frame: From 30 minute before surgery to postoperative 24th hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Derived from this study: PubMed 41315952Balta MG, Kolukcu V, Sahin AT, Genc A, Suren M, Okan I. Is there a difference in the postoperative quality of recovery and analgesia between erector spinae and serratus anterior plane blocks following modified radical mastectomy: a randomized controlled study. BMC Anesthesiol. 2025 Nov 29;25(1):597. doi: 10.1186/s12871-025-03477-1.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing serratus anterior plane block and erector spina plane block in people with Mastectomy and Pain, Postoperative, run by Tokat Gaziosmanpasa University.
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: status not confirmed, as of the sponsor's last update on 12 Mar 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mehtap gürler balta, MD (+903562129500 ext. 3494, drmehtapgurler@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesic consumption (time frame: From at the end of surgery (at postoperative 0th hour) to postoperative 24th 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 NCT04296188, which also lists 1 linked publication.
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 12 Mar 2020.