AnalgesiaNCT04248608
Perioperative Analgesic Modalities for Breast Cancer Surgeries
A study testing serratus plane block, erector spinae block and Morphine Sulfate in people with Analgesia, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
The incidence of breast cancer is among women world wide, detection increased with introduction of mammography as a screening tool. surgical resection of breast cancer contributes to the generation of acute and chronic post mastectomy pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Analgesia
- What is being tested?
- serratus plane block, erector spinae block and Morphine Sulfate
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Jan 2020to 1 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female 18-65 years old patients undergoing modified radical mastectomy
Who cannot join
- patient refusal, local infection at site of block coagulation defect abnormal kidney or liver functions
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of anesthesia and pain medicine. National Cancer Institute
Cairo, 11796
About this study
The incidence of breast cancer is among women world wide, detection increased with introduction of mammography as a screening tool. surgical resection of breast cancer contributes to the generation of acute and chronic post mastectomy pain. This study aims at comparing the effect of erector spinae block versus serratus block versus intravenous morphine in patients undergoing modified radical mastectomy for breast cancer surgeries regarding pain control and possible side effects
Read the detailed description
One of the most common types of cancer affecting women is breast cancer. Surgical resection is one of the main approaches applied for solid tumors. surgical approach for breast cancer involve the breast region. Various analgesic modalities are used for proper perioperative pain control. Morphine has always been considered as the gold standard analgesic, however opioids have multiple side effects. Several loco-regional techniques have been introduced for breast surgery pain management including serratus plane block (SPB) and erector spinae plane (ESP) block. In this study the investigators are comparing the effect of erector spinae block versus serratus block versus intravenous morphine in patients undergoing modified radical mastectomy for breast cancer surgeries regarding intraoperative and postoperative analgesia, time to first analgesic, any possible side effects
- Conditions
- Analgesia
- Being tested
- serratus plane block, erector spinae block, Morphine Sulfate
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serratus plane blockProcedure or surgery
Also called SAPB
ultrasound guided block
erector spinae blockProcedure or surgery
Also called ESPB
ultrasound guided block
Morphine SulfateDrug
Also called opioid
intravenous morphine sulfate 0.1 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| erector spinae block | Experimental | Ultrasound guided erector spinae block with will be done after induction of intravenous anesthesia. After identification of trapezius, rhomboid major, and erector spinae muscles. The needle will be inserted in a cephalad-to-caudal direction until the tip contact transverse process and the needle tip is visualized in the plane deep to the erector spinae muscle. The needle tip position is confirmed by visualizing linear spread of test dose between the muscles after injection. A total dose of 25 mL of 0.25% bupivacaine will be injected. Receives: Procedure: erector spinae block |
| serratus anterior block | Experimental | Ultrasound guided serratus anterior block will be done after induction of intravenous anesthesia. The serratus anterior, latissimus dorsi, and the intercostal muscles will be identified in the fourth and fifth intercostal level, an 18 G Tuohy needle will be advanced in the plane between the serratus anterior muscle and the intercostal muscles. A total dose of bupivacaine 25ml in a concentration of 0.25% will be administered under the serratus muscle after a test dose using an in-plane technique. Receives: Procedure: serratus plane block |
| intravenous morphine | Active comparator | intravenous morphine will be administrated in a dose of 0.1 mg per kg after induction of general anesthesia Receives: Drug: Morphine Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue score
minimum score (0), maximum score (10) maximum score (10)
Measured: 24 hours
Total morphine consumption
total morphine in mg received in first 24 hours postoprative
Measured: 24 hours
First time to receive morphine
first time to receive morphine in the postoperative period (first 24 hours)
Measured: 24 hours
Secondary outcomes (2)
mean arterial blood pressure
hemodynamic parameters
Measured: 24 hours
heart rate
hemodynamic parameters
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 posted30 Jan 2020
- Study start28 Jan 2020
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
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 AnalgesiaStudies 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
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Youssef Elsabeeny, National Cancer Institute, Egypt
- Investigators
- walaa Y Elsabeeny, MD, Principal investigator, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04248608
- Sponsor's protocol ID
- AP1907-50101
- Status last verified
- Jul 2020
- First submitted
- 22 Jan 2020
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elsabeeny WY, Shehab NN, Wadod MA, Elkady MA. Perioperative Analgesic Modalities for Breast Cancer Surgeries: A Prospective Randomized Controlled Trial. J Pain Res. 2020 Nov 12;13:2885-2894. doi: 10.2147/JPR.S274808. eCollection 2020.
PubMed 33209056
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Analgesic Modalities for Breast Cancer Surgeries
- ClinicalTrials.gov ID
- NCT04248608
- Acronym / sponsor ID
- AP1907-50101
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 30 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.
The incidence of breast cancer is among women world wide, detection increased with introduction of mammography as a screening tool. surgical resection of breast cancer contributes to the generation of acute and chronic post mastectomy pain. This study aims at comparing the effect of erector spinae block versus serratus block versus intravenous morphine in patients undergoing modified radical mastectomy for breast cancer surgeries regarding pain control and possible side effects
Detailed description
One of the most common types of cancer affecting women is breast cancer. Surgical resection is one of the main approaches applied for solid tumors. surgical approach for breast cancer involve the breast region. Various analgesic modalities are used for proper perioperative pain control. Morphine has always been considered as the gold standard analgesic, however opioids have multiple side effects. Several loco-regional techniques have been introduced for breast surgery pain management including serratus plane block (SPB) and erector spinae plane (ESP) block. In this study the investigators are comparing the effect of erector spinae block versus serratus block versus intravenous morphine in patients undergoing modified radical mastectomy for breast cancer surgeries regarding intraoperative and postoperative analgesia, time to first analgesic, any possible side effects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| erector spinae block | Experimental | Procedure: erector spinae blockUltrasound guided erector spinae block with will be done after induction of intravenous anesthesia. After identification of trapezius, rhomboid major, and erector spinae muscles. The needle will be inserted in a cephalad-to-caudal direction until the tip contact transverse process and the needle tip is visualized in the plane deep to the erector spinae muscle. The needle tip position is confirmed by visualizing linear spread of test dose between the muscles after injection. A total dose of 25 mL of 0.25% bupivacaine will be injected. |
| serratus anterior block | Experimental | Procedure: serratus plane blockUltrasound guided serratus anterior block will be done after induction of intravenous anesthesia. The serratus anterior, latissimus dorsi, and the intercostal muscles will be identified in the fourth and fifth intercostal level, an 18 G Tuohy needle will be advanced in the plane between the serratus anterior muscle and the intercostal muscles. A total dose of bupivacaine 25ml in a concentration of 0.25% will be administered under the serratus muscle after a test dose using an in-plane technique. |
| intravenous morphine | Active comparator | Drug: Morphine Sulfateintravenous morphine will be administrated in a dose of 0.1 mg per kg after induction of general anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- female 18-65 years old patients undergoing modified radical mastectomy
Key exclusion criteria (1 listed)
- patient refusal, local infection at site of block coagulation defect abnormal kidney or liver functions
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 plane blockAlso: SAPBultrasound guided block | Procedure or surgery | serratus anterior block |
| erector spinae blockAlso: ESPBultrasound guided block | Procedure or surgery | erector spinae block |
| Morphine SulfateAlso: opioidintravenous morphine sulfate 0.1 mg/kg | Drug | intravenous morphine |
Primary outcome
Visual analogue score
Time frame: 24 hours
minimum score (0), maximum score (10) maximum score (10)
Total morphine consumption
Time frame: 24 hours
total morphine in mg received in first 24 hours postoprative
First time to receive morphine
Time frame: 24 hours
first time to receive morphine in the postoperative period (first 24 hours)
2 secondary outcomes
mean arterial blood pressure
Time frame: 24 hours
heart rate
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 21 Jul 2020.
- Derived from this study: PubMed 33209056Elsabeeny WY, Shehab NN, Wadod MA, Elkady MA. Perioperative Analgesic Modalities for Breast Cancer Surgeries: A Prospective Randomized Controlled Trial. J Pain Res. 2020 Nov 12;13:2885-2894. doi: 10.2147/JPR.S274808. eCollection 2020.
- 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.
walaa Y Elsabeeny, MD principal investigator
Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing serratus plane block, erector spinae block and Morphine Sulfate in people with Analgesia, run by National Cancer Institute, Egypt 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 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 21 Jul 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 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?
Visual analogue score (time frame: 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?
On the ClinicalTrials.gov record for NCT04248608, 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 21 Jul 2020.