Cancer BreastPhase 2/3NCT04429893
Magnesium Sulphate to Bupivicaine in Serratus Anterior Plane Block in Modified Radical Mastectomy
A Phase 2/3 study testing magnesium sulphate and bupivicaine in people with Cancer Breast and Chronic Pain Syndrome, run by Alexandria University at 1 site in Egypt.
Trial summary
Modified radical mastectomy may be associated with severe post-operative pain, leading to chronic pain syndrome which usually requires optimal perioperative pain management. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Cancer Breast, Chronic Pain Syndrome
- What is being tested?
- magnesium sulphate and bupivicaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to Sep 2022
- Phase
- Phase 2/3
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult female patients
- American Society Of Anesthesiologists (ASA) class I or II
- scheduled for elective unilateral modified radical mastectomy
Who cannot join
- patient refusal
- bilateral breast surgery
- coagulation disorders
- body mass index> 35
- allergy to local anaesthetics or magnesium sulphate
- severe respiratory or cardiac disorders
- pre-existing neurological deficits
- liver or renal insufficiency
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Rehab Abd Elraof Abd Elaziz
Alexandria, Smouha, 000000
Rehab A. Abd Elaziz, Ass. Prof., 01001073703 ext. 020, trcium2002@yahoo.com
About this study
Official title: Effectiveness of Adding Magnesium Sulphate to Bupivicaine in Ultrasound Guided Serratus Anterior Plane Block in Patients Undergoing Modified Radical Mastectomy
Modified radical mastectomy may be associated with severe post-operative pain, leading to chronic pain syndrome which usually requires optimal perioperative pain management.
Read the detailed description
Patients will be randomly into two equal groups (40 patients each) according to the adjuvant added to the local anesthetic (bupivacaine) in the serratus anterior plane block using a computer-generated random numbers concealed in sealed opaque envelopes. Group B: The patients will receive 20 ml of 0.5% bupivacaine plus 5 ml 0.9% normal saline with total volume 25 ml. Group BM: The patients will receive 20 ml of 0.5% bupivacaine plus 150 mg magnesium sulphate in 0.9% normal saline with a total volume of 25 ml.
- Conditions
- Cancer Breast, Chronic Pain Syndrome
- Being tested
- magnesium sulphate, bupivicaine
- Keywords
- serratus anterior plane block, magnesium sulphate
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnesium sulphateDrug
assess the pain intensity of magnesium sulphate as an adjuvant to bupivacaine in serratus anterior plane block for modified radical mastectomy
bupivicaineDrug
assess the pain intensity of magnesium sulphate as an adjuvant to bupivacaine in serratus anterior plane block for modified radical mastectomy
| Study group | Role | What they receive |
|---|---|---|
| Group BM | Experimental | The patients will receive 20 ml of 0.5% bupivacaine plus 150 mg magnesium sulphate in 0.9% normal saline with a total volume of 25 ml. Receives: Drug: magnesium sulphate; Drug: bupivicaine |
| Group B | Active comparator | The patients will receive 20 ml of 0.5% bupivacaine plus 5 ml 0.9% normal saline with total volume 25 ml Receives: Drug: bupivicaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of the pain intensity
Pain assessment by visual analogue scale
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 posted12 Jun 2020
- Study start1 Jan 2022
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer BreastStudies of the same condition, open and under way.
- More trials run by Alexandria 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 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rehab zayed, Alexandria University
- Investigators
- Rehab A. Abd Elaziz, Ass.Prof., Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429893
- Sponsor's protocol ID
- 0304543
- Status last verified
- Jul 2022
- First submitted
- 8 Jun 2020
- Last updated
- 2 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Adding Magnesium Sulphate to Bupivicaine in Ultrasound Guided Serratus Anterior Plane Block in Patients Undergoing Modified Radical Mastectomy
- ClinicalTrials.gov ID
- NCT04429893
- Acronym / sponsor ID
- 0304543
- Conditions
- Cancer Breast, Chronic Pain Syndrome
- Keywords
- serratus anterior plane block, magnesium sulphate
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 12 Jun 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.
Modified radical mastectomy may be associated with severe post-operative pain, leading to chronic pain syndrome which usually requires optimal perioperative pain management.
Detailed description
Patients will be randomly into two equal groups (40 patients each) according to the adjuvant added to the local anesthetic (bupivacaine) in the serratus anterior plane block using a computer-generated random numbers concealed in sealed opaque envelopes. Group B: The patients will receive 20 ml of 0.5% bupivacaine plus 5 ml 0.9% normal saline with total volume 25 ml. Group BM: The patients will receive 20 ml of 0.5% bupivacaine plus 150 mg magnesium sulphate in 0.9% normal saline with a total volume of 25 ml.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group BM | Experimental | Drug: magnesium sulphate, Drug: bupivicaineThe patients will receive 20 ml of 0.5% bupivacaine plus 150 mg magnesium sulphate in 0.9% normal saline with a total volume of 25 ml. |
| Group B | Active comparator | Drug: bupivicaineThe patients will receive 20 ml of 0.5% bupivacaine plus 5 ml 0.9% normal saline with total volume 25 ml |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult female patients
- American Society Of Anesthesiologists (ASA) class I or II
- scheduled for elective unilateral modified radical mastectomy
Key exclusion criteria (8 listed)
- patient refusal
- bilateral breast surgery
- coagulation disorders
- body mass index> 35
- allergy to local anaesthetics or magnesium sulphate
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 |
|---|---|---|
| magnesium sulphateassess the pain intensity of magnesium sulphate as an adjuvant to bupivacaine in serratus anterior plane block for modified radical mastectomy | Drug | Group BM |
| bupivicaineassess the pain intensity of magnesium sulphate as an adjuvant to bupivacaine in serratus anterior plane block for modified radical mastectomy | Drug | Group B, Group BM |
Primary outcome
assessment of the pain intensity
Time frame: 24 hours
Pain assessment by visual analogue scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
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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.
Rehab A. Abd Elaziz, Ass.Prof. principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing magnesium sulphate and bupivicaine in people with Cancer Breast and Chronic Pain Syndrome, run by Alexandria 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 8 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 2 Aug 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Rehab A. Abd Elaziz, Ass. Prof. (01001073703 ext. 020, trcium2002@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of the pain intensity (time frame: 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 2 Aug 2022.