Magnesium SulfateNCT06815887
Adding Magnesium Sulfate to Local Anesthetic in Combined Pectoral Nerve and Stellate Ganglion Block for Postoperative Pain Control After Modified Radical Mastectomy
A study testing Bupivacaine and Bupivacaine + Magnesium sulfate in people with Magnesium Sulfate and Local Anesthetic, run by Cairo University at 1 site in Egypt.
Trial summary
We aim to study the effect of adding magnesium sulfate as an adjuvant to the local anesthetic used in the combined Pectoralis Nerve Block II (PECS II) and stellate ganglion block for postoperative pain control in patients undergoing modified radical mastectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Magnesium Sulfate, Local Anesthetic, Pectoral Nerve
- What is being tested?
- Bupivacaine and Bupivacaine + Magnesium sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2025to 28 Feb 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Female gender.
- American Society of Anesthesiologists (ASA) physical status II or III.
- Patients scheduled for elective modified radical mastectomy for breast cancer.
- Body mass index (BMI): > 20 kg/m2 and < 40 kg/m2.
Who cannot join
- Bleeding tendency due to coagulopathy,
- Patients with opioid dependence or alcohol or drug abuse,
- Significant liver and renal sufficiency
- Patients with psychiatric illnesses that prevent them from proper perception and assessment of pain.
- Local infection at the site of the block.
- Known hypersensitivity or allergy to magnesium sulfate or local anesthetics.
- Patients with chronic pain syndromes or pre-existing neuropathic pain conditions.
- Pregnant or lactating individuals.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Adding Magnesium Sulfate to Local Anesthetic in Combined Pectoral Nerve and Stellate Ganglion Block for Postoperative Pain Control After Modified Radical Mastectomy
We aim to study the effect of adding magnesium sulfate as an adjuvant to the local anesthetic used in the combined Pectoralis Nerve Block II (PECS II) and stellate ganglion block for postoperative pain control in patients undergoing modified radical mastectomy.
Read the detailed description
Post-operative pain from breast surgery can be controlled by regular pain medications such as paracetamol, non-steroidal anti-inflammatory (NSAIDs), and narcotics. Nerve blocks are commonly used as multimodal approaches for acute post-operative pain relief.
Pectoral and stellate ganglion blocks are regional anesthesia techniques that target the thoracic nerves and sympathetic nerve ganglia to provide analgesia for the upper extremity and chest regions. When combined, these blocks have shown promising results in alleviating perioperative pain for patients undergoing modified radical mastectomy.
Magnesium sulfate, a well-known adjuvant, has been studied extensively for its analgesic properties and anti-inflammatory effects.
- Conditions
- Magnesium Sulfate, Local Anesthetic, Pectoral Nerve, Stellate Ganglion Block, Postoperative Pain, Modified Radical Mastectomy
- Being tested
- Bupivacaine, Bupivacaine + Magnesium sulfate
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Patients received the combined pectoralis nerve block II (PECS II) (20 mL) and stellate ganglion block (5 mL) using 0.5% bupivacaine (local anesthetic) without magnesium sulfate.
Bupivacaine + Magnesium sulfateDrug
Patients received the combined (20 mL) pectoralis nerve block II (PECS II) and stellate ganglion block (5 mL) using 0.5% bupivacaine (local anesthetic) mixed with 2.5 mL magnesium sulfate (10%), i.e., 250 mg.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Patients will receive the combined pectoralis nerve block II (PECS II)(20 mL) and stellate ganglion block (5 mL) using 0.5% bupivacaine (local anesthetic) without magnesium sulfate. Receives: Drug: Bupivacaine |
| Group B | Experimental | Patients will receive the combined (20 mL) pectoralis nerve block II (PECS II) and stellate ganglion block (5 mL) using 0.5% bupivacaine (local anesthetic) mixed with 2.5 mL magnesium sulfate (10%), i.e., 250 mg. Receives: Drug: Bupivacaine + Magnesium sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
With numeric rating scale (NRS) rest score ≥ 3 or NRS evoked score ≥ 4, morphine will be administered intravenously by a dose of 0.05 mg/kg at 30-minute intervals until NRS rest score < 3 or NRS evoked score < 4.
Measured: 24 hours postoperatively
Secondary outcomes (3)
Degree of pain
The severity of pain will be assessed postoperatively using a numeric rating scale (NRS) both at rest and evoked (0 = no pain and 10 = worst imaginable pain). NRS will be recorded at 1, 2, 4, 6, 8, 10, 12, and 24 hours postoperatively.
Measured: 24 hours postoperatively
Time to first request analgesia
The time to first request analgesia will be recorded from the end of surgery till the first dose of morphine is administrated.
Measured: 24 hours postoperatively
Incidence of adverse events
Incidence of adverse events such as nausea and vomiting will be recorded.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start15 Feb 2025
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnesium SulfateStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ahmed Ali Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06815887
- Sponsor's protocol ID
- AP2311-201-091
- Status last verified
- May 2026
- First submitted
- 1 Feb 2025
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Magnesium Sulfate to Local Anesthetic in Combined Pectoral Nerve and Stellate Ganglion Block for Postoperative Pain Control After Modified Radical Mastectomy
- ClinicalTrials.gov ID
- NCT06815887
- Acronym / sponsor ID
- AP2311-201-091
- Conditions
- Magnesium Sulfate, Local Anesthetic, Pectoral Nerve, Stellate Ganglion Block, Postoperative Pain, Modified Radical Mastectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 10 Feb 2025 (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.
We aim to study the effect of adding magnesium sulfate as an adjuvant to the local anesthetic used in the combined Pectoralis Nerve Block II (PECS II) and stellate ganglion block for postoperative pain control in patients undergoing modified radical mastectomy.
Detailed description
Post-operative pain from breast surgery can be controlled by regular pain medications such as paracetamol, non-steroidal anti-inflammatory (NSAIDs), and narcotics. Nerve blocks are commonly used as multimodal approaches for acute post-operative pain relief.
Pectoral and stellate ganglion blocks are regional anesthesia techniques that target the thoracic nerves and sympathetic nerve ganglia to provide analgesia for the upper extremity and chest regions. When combined, these blocks have shown promising results in alleviating perioperative pain for patients undergoing modified radical mastectomy.
Magnesium sulfate, a well-known adjuvant, has been studied extensively for its analgesic properties and anti-inflammatory effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: BupivacainePatients will receive the combined pectoralis nerve block II (PECS II)(20 mL) and stellate ganglion block (5 mL) using 0.5% bupivacaine (local anesthetic) without magnesium sulfate. |
| Group B | Experimental | Drug: Bupivacaine + Magnesium sulfatePatients will receive the combined (20 mL) pectoralis nerve block II (PECS II) and stellate ganglion block (5 mL) using 0.5% bupivacaine (local anesthetic) mixed with 2.5 mL magnesium sulfate (10%), i.e., 250 mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years.
- Female gender.
- American Society of Anesthesiologists (ASA) physical status II or III.
- Patients scheduled for elective modified radical mastectomy for breast cancer.
- Body mass index (BMI): > 20 kg/m2 and < 40 kg/m2.
Key exclusion criteria (8 listed)
- Bleeding tendency due to coagulopathy,
- Patients with opioid dependence or alcohol or drug abuse,
- Significant liver and renal sufficiency
- Patients with psychiatric illnesses that prevent them from proper perception and assessment of pain.
- Local infection at the site of the block.
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 |
|---|---|---|
| BupivacainePatients received the combined pectoralis nerve block II (PECS II) (20 mL) and stellate ganglion block (5 mL) using 0.5% bupivacaine (local anesthetic) without magnesium sulfate. | Drug | Group A |
| Bupivacaine + Magnesium sulfatePatients received the combined (20 mL) pectoralis nerve block II (PECS II) and stellate ganglion block (5 mL) using 0.5% bupivacaine (local anesthetic) mixed with 2.5 mL magnesium sulfate (10%), i.e., 250 mg. | Drug | Group B |
Primary outcome
Total morphine consumption
Time frame: 24 hours postoperatively
With numeric rating scale (NRS) rest score ≥ 3 or NRS evoked score ≥ 4, morphine will be administered intravenously by a dose of 0.05 mg/kg at 30-minute intervals until NRS rest score < 3 or NRS evoked score < 4.
3 secondary outcomes
Degree of pain
Time frame: 24 hours postoperatively
Time to first request analgesia
Time frame: 24 hours postoperatively
Incidence of adverse events
Time frame: 24 hours postoperatively
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 22 May 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Magnesium Sulfate
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Active, not recruitingObservational study
The Effect of Magnesium on Post-spinal Headaches
Post-spinal Headache
Not yet recruitingPhase 4
Two Doses of IV Magnesium Sulfate for Prevention of Post-Spinal Shivering
Post Spinal Anesthesia Shivering
Not yet recruitingPhase 4
Biomarkers in Management of Post Partum Preeclampsia
Preeclampsia Severe, Preeclampsia Postpartum
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 Bupivacaine and Bupivacaine + Magnesium sulfate in people with Magnesium Sulfate and Local Anesthetic, run by Cairo 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 5 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: finished, as of the sponsor's last update on 22 May 2026. 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?
Total morphine consumption (time frame: 24 hours postoperatively). 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 22 May 2026.