Modified Radical MastectomyNCT07460115
Comparison of Mean Duration of Analgesia Following the Administration of Bupivacaine With and Without Magnesium Sulphate in Ultrasound Guided Erector Spinae Plane Block in Modified Radical Mastectomy Patients
A study testing Group B (bupivacaine) and Bupivacaine plus magnesium sulfate in people with Modified Radical Mastectomy, run by Gulab Devi Hospital at 1 site in Pakistan.
Trial summary
To compare mean duration of postoperative analgesia following the administration of bupivacaine with and without magnesium sulphate in erector spinae plane block in modified radical mastectomy patients. Read more about this study
- Who is it for?
- Ages 25 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Modified Radical Mastectomy
- What is being tested?
- Group B (bupivacaine) and Bupivacaine plus magnesium sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 28 May 2025to 28 Nov 2025
- 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 25 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female patients having ASA 1 and Il being aged 2 5 - 60 years and undergoing one sided breast cancer surgery * Patients who sign written informed consent to participate in the study.
Who cannot join
- Patients having contraindications for regional blocks (c.g., infection a t the injection site, coagulopathy), allergy to the drugs used i n the study Patients who received radiotherapy, and patients need axillary dissection • Patients with known hypersensitivity to local anesthetic drug (Bupivacaine). Patients with coagulation disorders or receiving anti-coagulant therapy (INR>2.0).
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Gulab Devi Hospital Ferozpur Road Lahore
Lahore, Punjab Province, 54600
About this study
To compare mean duration of postoperative analgesia following the administration of bupivacaine with and without magnesium sulphate in erector spinae plane block in modified radical mastectomy patients.
Read the detailed description
There is a difference in mean duration of analgesia following the administration of bupivacaine with and without magnesium sulphate in erector spinae plane block in modified radical mastectomy patients.
- Conditions
- Modified Radical Mastectomy
- Being tested
- Group B (bupivacaine), Bupivacaine plus magnesium sulfate
- Keywords
- magnesium sulphate, bupivacaine, modified radical mastectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group B (bupivacaine)Drug
Also called Group bupivacaine
receive 20 ml of 0.25% bupivacaine on the operated side for the Erector Spinae Plane (ESP) block.
Bupivacaine plus magnesium sulfateDrug
20 ml of 0.25% bupivacaine plus 250 mg of magnesium sulfate on each side.
| Study group | Role | What they receive |
|---|---|---|
| Group bupivacaine | Active comparator | 20 ml of 0.25% bupivacaine Receives: Drug: Group B (bupivacaine) |
| Group BMG(bupivacaine plus magnesium sulfate) | Experimental | 20 ml of 0.25% bupivacaine plus 250 mg of magnesium sulfate Receives: Drug: Bupivacaine plus magnesium sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative analgesia
There is a difference in mean duration of analgesia following the administration of bupivacaine with and without magnesium sulphate in erector spinae plane block in modified radical mastectomy patients.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start28 May 2025
- Primary completion28 Nov 2025
- Study completion28 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Modified Radical 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulab Devi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fareeha Afzaal, Gulab Devi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460115
- Sponsor's protocol ID
- AAMC/IRB/EA/47/2025
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Mean Duration of Analgesia Following the Administration of Bupivacaine With and Without Magnesium Sulphate in Ultrasound Guided Erector Spinae Plane Block in Modified Radical Mastectomy Patients
- ClinicalTrials.gov ID
- NCT07460115
- Acronym / sponsor ID
- AAMC/IRB/EA/47/2025
- Conditions
- Modified Radical Mastectomy
- Keywords
- magnesium sulphate, bupivacaine, modified radical mastectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gulab Devi HospitalUniversity, hospital or other
- Study start
- 28 May 2025 (actual)
- Primary completion
- 28 Nov 2025 (actual)
- Study completion
- 28 Nov 2025 (actual)
- First posted
- 10 Mar 2026 (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.
To compare mean duration of postoperative analgesia following the administration of bupivacaine with and without magnesium sulphate in erector spinae plane block in modified radical mastectomy patients.
Detailed description
There is a difference in mean duration of analgesia following the administration of bupivacaine with and without magnesium sulphate in erector spinae plane block in modified radical mastectomy patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group bupivacaine | Active comparator | Drug: Group B (bupivacaine)20 ml of 0.25% bupivacaine |
| Group BMG(bupivacaine plus magnesium sulfate) | Experimental | Drug: Bupivacaine plus magnesium sulfate20 ml of 0.25% bupivacaine plus 250 mg of magnesium sulfate |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female patients having ASA 1 and Il being aged 2 5 - 60 years and undergoing one sided breast cancer surgery * Patients who sign written informed consent to participate in the study.
Key exclusion criteria (1 listed)
- Patients having contraindications for regional blocks (c.g., infection a t the injection site, coagulopathy), allergy to the drugs used i n the study Patients who received radiotherapy, and patients need axillary dissection • Patients with known hypersensitivity to local anesthetic drug (Bupivacaine). Patients with coagulation disorders or receiving anti-coagulant therapy (INR>2.0).
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 |
|---|---|---|
| Group B (bupivacaine)Also: Group bupivacainereceive 20 ml of 0.25% bupivacaine on the operated side for the Erector Spinae Plane (ESP) block. | Drug | Group bupivacaine |
| Bupivacaine plus magnesium sulfate20 ml of 0.25% bupivacaine plus 250 mg of magnesium sulfate on each side. | Drug | Group BMG(bupivacaine plus magnesium sulfate) |
Primary outcome
post-operative analgesia
Time frame: 20 minutes
There is a difference in mean duration of analgesia following the administration of bupivacaine with and without magnesium sulphate in erector spinae plane block in modified radical mastectomy patients.
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 10 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Modified Radical Mastectomy
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
Recruiting
Comparison of Postoperative Analgesic Efficacy of Two Different Blocks in Modified Radical Mastectomy Surgery
Breast Cancer, Postoperative Pain
Not yet recruiting
Perioperative Mirogabalin for Pain Relief After Modified Radical Mastectomy
Breast Cancer, Post Operative Pain
Recruiting
Ultrasound-Guided SPSIP Versus ESPB for Postoperative Pain After Modified Radical Mastectomy
Breast Cancer, Postoperative Pain
Not yet recruiting
Trial Evaluating the Analgesic Efficacy of Magnesium Sulfate as an Adjuvant to Bupivacaine in Local Wound Infiltration for Patients Undergoing Modified Radical Mastectomy (MRM) With Axillary Clearance
Modified Radical Mastectomy
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 Group B (bupivacaine) and Bupivacaine plus magnesium sulfate in people with Modified Radical Mastectomy, run by Gulab Devi Hospital at 1 site in Pakistan.
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 10 Mar 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 Pakistan. 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?
post-operative analgesia (time frame: 20 minutes). 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 10 Mar 2026.