Breast Cancer Postoperative PainNCT04372862
Comparison Between Serratus Anterior Plane Block and Erector Spinae Plane Block for Mastectomy
A study testing Plane block in people with Breast Cancer Postoperative Pain, run by Suez Canal University at 1 site in Egypt.
Trial summary
In this study, we are comparing two different techniques of plane blocks to control postoperative mastectomy pain serratus anterior plane block and erector spinae plane block, both are done with ultrasonic guidance We are recording the first time of analgesia request postoperatively as a primary outcome Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Breast Cancer Postoperative Pain
- What is being tested?
- Plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2019to 30 Jul 2020
- 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 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patient age 20 to 65
- ASA I, II
- Scheduled for mastectomy
Who cannot join
- Allergy to local anaesthetics
- Infection at the site of performing the block
- Morbidly obese patient of body mass index more than 40 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Serratus Anterior Plane Block and Erector Spinae Plane Block to Control Postmastectomy Pain
In this study, we are comparing two different techniques of plane blocks to control postoperative mastectomy pain serratus anterior plane block and erector spinae plane block, both are done with ultrasonic guidance We are recording the first time of analgesia request postoperatively as a primary outcome
- Conditions
- Breast Cancer Postoperative Pain
- Being tested
- Plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plane blockProcedure or surgery
Also called Block
Two different plane blocks to control post-mastectomy pain
| Study group | Role | What they receive |
|---|---|---|
| Serratus anterior plane block | Active comparator | Serratus anterior plane block was performed in the supine position placing the ipsilateral upper limb in abduction 90 degrees position. Aiming to find the serratus anterior muscle the investigator identified the fifth rib in the mid-axillary line by the linear probe in the sagittal plane. The latissimus dorsi muscle (superficial and posterior), teres major muscle (superior) and serratus muscles (deep and inferior) were detected using ultrasound. The investigator penetrated the serratus anterior muscle by a 25 GA, 90 mm spinal needle in-plane concerning the ultrasound probe from superoanterior to posteroinferior to inject deep to it. Receives: Procedure: Plane block |
| Erector spinae plane block | Active comparator | Erector spinae plane block was performed at lateral decubitus with the operation site up, the vertebrae were counted from cephalad to caudal direction until reaching T5 spinous process as the first palpable spinous process is C7. The ultrasound probe was placed vertically 3 cm lateral to the T5 spinous process. Three muscles were identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. The needle was introduced from superior to inferior direction in-plane until the tip lay deep to erector spinae muscle. Receives: Procedure: Plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
First time analgesia request
The first time the patient ask for analgesia to control postoperative pain
Measured: Postoperative up to 24 hours
Secondary outcomes (2)
Total analgesic consumption
The total calculated analgesics that were administered to control post operative pain
Measured: Postoperative up to 24 hours
visual analogue scale
A subjective method to measure pain, where 0=no pain and 10 = worst comprehensible pain
Measured: Every two hours for 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start1 Oct 2019
- Primary completion30 May 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Postoperative PainStudies of the same condition, open and under way.
- More trials run by Suez Canal 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective comparative randomized clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrhman Alshawadfy, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372862
- Sponsor's protocol ID
- ASPB vs ESBP for mastectomy
- Status last verified
- Sep 2022
- First submitted
- 1 May 2020
- Last updated
- 29 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Serratus Anterior Plane Block and Erector Spinae Plane Block to Control Postmastectomy Pain
- ClinicalTrials.gov ID
- NCT04372862
- Acronym / sponsor ID
- ASPB vs ESBP for mastectomy
- Conditions
- Breast Cancer Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 4 May 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.
In this study, we are comparing two different techniques of plane blocks to control postoperative mastectomy pain serratus anterior plane block and erector spinae plane block, both are done with ultrasonic guidance We are recording the first time of analgesia request postoperatively as a primary outcome
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- prospective comparative randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Serratus anterior plane block | Active comparator | Procedure: Plane blockSerratus anterior plane block was performed in the supine position placing the ipsilateral upper limb in abduction 90 degrees position. Aiming to find the serratus anterior muscle the investigator identified the fifth rib in the mid-axillary line by the linear probe in the sagittal plane. The latissimus dorsi muscle (superficial and posterior), teres major muscle (superior) and serratus muscles (deep and inferior) were detected using ultrasound. The investigator penetrated the serratus anterior muscle by a 25 GA, 90 mm spinal needle in-plane concerning the ultrasound probe from superoanterior to posteroinferior to inject deep to it. |
| Erector spinae plane block | Active comparator | Procedure: Plane blockErector spinae plane block was performed at lateral decubitus with the operation site up, the vertebrae were counted from cephalad to caudal direction until reaching T5 spinous process as the first palpable spinous process is C7. The ultrasound probe was placed vertically 3 cm lateral to the T5 spinous process. Three muscles were identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. The needle was introduced from superior to inferior direction in-plane until the tip lay deep to erector spinae muscle. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patient age 20 to 65
- ASA I, II
- Scheduled for mastectomy
Key exclusion criteria (3 listed)
- Allergy to local anaesthetics
- Infection at the site of performing the block
- Morbidly obese patient of body mass index more than 40 kg/m2
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 |
|---|---|---|
| Plane blockAlso: BlockTwo different plane blocks to control post-mastectomy pain | Procedure or surgery | Erector spinae plane block, Serratus anterior plane block |
Primary outcome
First time analgesia request
Time frame: Postoperative up to 24 hours
The first time the patient ask for analgesia to control postoperative pain
2 secondary outcomes
Total analgesic consumption
Time frame: Postoperative up to 24 hours
visual analogue scale
Time frame: Every two hours for 24 hours postoperative
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 29 Sep 2022.
- Individual participant dataSharing planned: No
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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 study testing Plane block in people with Breast Cancer Postoperative Pain, run by Suez Canal University at 1 site in Egypt.
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 3 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 29 Sep 2022. 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 Egypt. 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?
First time analgesia request (time frame: Postoperative up to 24 hours). 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 29 Sep 2022; AzTrials last refreshed its copy on 6 Nov 2026.