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Breast CancerNCT07923643

Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain

A study testing Bupivacaine, Dexamethasone and Magnesium sulfate in people with Breast Cancer and Postoperative Pain, run by Assiut University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This prospective, randomized, double-blind, controlled clinical trial will evaluate whether adding magnesium sulfate to dexamethasone-augmented ultrasound-guided pectoral nerve block improves postoperative recovery and analgesia in female patients undergoing elective modified radical mastectomy under general… Read more about this study

Who is it for?
Ages 18 to 70 years, women only
What is being tested?
Bupivacaine, Dexamethasone and Magnesium sulfate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
1 Nov 2026to Nov 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients aged 18-70 years.
  • ASA physical status I-III.
  • Scheduled for elective modified radical mastectomy.
  • Able to understand the study protocol and complete the QoR-15 questionnaire.
  • Provided written informed consent.

Who cannot join

  • Patient refusal.
  • Allergy to local anesthetics, dexamethasone, magnesium sulfate, or study medications.
  • Coagulopathy or anticoagulant therapy.
  • Local infection at the injection site.
  • Severe hepatic or renal impairment.
  • Neuromuscular disorders.
Show all 10Show fewer
  • Chronic opioid use or chronic pain syndromes.
  • Pregnancy or lactation.
  • BMI >35 kg/m².
  • Cognitive impairment or inability to communicate effectively.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Madona M Noman, MD contact

201006265867

madonamisheal90@yahoo.com

Romany G Gendy, MD contact

201229869146

madonamisheal@gmail.com

Egypt1 site
  • South Egypt Cancer Institute, Assiut University, Egypt

    Asyut

    Madona South Egypt Cancer Institute, Assiut University, Egypt, 201006265867, madonamisheal90@yahoo.com

Other trials in Egypt

About this study

Official title: Effect of Magnesium Sulfate Added to Dexamethasone-Augmented Ultrasound-Guided Pectoral Nerve Block (PECS) Block on Early Quality of Recovery and Chronic Post-Mastectomy Pain Following Modified Radical Mastectomy: A Prospective Randomized Double-Blind Controlled Trial

This prospective, randomized, double-blind, controlled clinical trial will evaluate whether adding magnesium sulfate to dexamethasone-augmented ultrasound-guided pectoral nerve block improves postoperative recovery and analgesia in female patients undergoing elective modified radical mastectomy under general anesthesia. Fifty-four participants will be allocated to two groups. Both groups will receive bupivacaine and dexamethasone for PECS block; the intervention group will additionally receive magnesium sulfate. The primary outcome will be the Quality of Recovery-15 (QoR-15) score at 24 hours after surgery. Secondary outcomes will include postoperative pain scores, opioid consumption, time to first rescue analgesia, postoperative nausea and vomiting, patient satisfaction, block-related complications, intraoperative fentanyl requirements, hemodynamic parameters, and chronic post-mastectomy pain assessed through six months.

Being tested
Bupivacaine, Dexamethasone, Magnesium sulfate
Keywords
Pectoral Nerve Block (PECS), Magnesium sulfate, dexamethasone, Quality of recovery, chronic pain
Medical subject headings
Breast Neoplasms, Pain, Postoperative, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BupivacaineDrug

    Patients will receive an ultrasound-guided PECS block (10 mL in PECS I and 20 mL in PECS II; total volume 30 mL) using 15ml of 0.5% Bupivacaine 75 mg in both groups

  • DexamethasoneDrug

    Dexamethasone 8 mg will be administered as an adjunct to the PECS block in both groups

  • Magnesium sulfateDrug

    Magnesium sulfate 250 mg will be administered as an adjunct to the PECS block in DM group only

Study groups in NCT07923643
Study groupRoleWhat they receive
Group DActive comparatorPatients will receive an ultrasound-guided PECS block (10 mL in PECS I and 20 mL in PECS II; total volume 30 mL) using 15ml of 0.5% Bupivacaine 75 mg mixed with 8mg dexamethasone (2ml) and diluted to 30ml with normal saline (13ml)
Receives: Drug: Bupivacaine; Drug: Dexamethasone
Group DMExperimentalPatients will receive an ultrasound-guided PECS block (10 mL in PECS I and 20 mL in PECS II; total volume 30 mL) using 15ml of 0.5% Bupivacaine 75mg mixed with 8mg dexamethasone (2ml),250mg magnesium sulfate (2.5ml) and diluted to 30ml with normal saline (10.5ml),
Receives: Drug: Bupivacaine; Drug: Dexamethasone; Drug: Magnesium sulfate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of Recovery-15 score at 24 hours after surgery

    Total score of the Quality of Recovery-15 questionnaire, ranging from 0 to 150, with higher scores indicating better postoperative recovery.

    Measured: 24 hours after surgery

Secondary outcomes (12)
  1. Chronic Post-Mastectomy Pain

    Assessing the presence or absence of chronic postoperative pain and its intensity using the Visual Analogue Scale (VAS)minimum value of 0, maximum value of 10, where higher scores mean a worse outcome

    Measured: Through 6 months postoperatively

  2. Postoperative Pain Intensity

    Evaluating postoperative pain intensity using the Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain).

    Measured: At arrival to Post- Anesthesia Care Unit (PACU) (0 hour), 2, 4, 6, 12, and 24 hours postoperatively.

  3. Total Postoperative Opioid Consumption

    Measuring the total morphine consumption required by the patient as rescue analgesia.

    Measured: During the first 24 hours postoperatively

  4. Time to First Request for Rescue Analgesia

    Recording the duration from the end of surgery until the patient first requests rescue analgesia (when Visual Analogue Scale (VAS)is 4 or more).

    Measured: Within the first 24 hours postoperatively

  5. Patient Satisfaction

    Evaluating patient satisfaction with postoperative pain management using a 5-point Likert scale (ranging from very dissatisfied to very satisfied)(minimum value of 1, maximum value of 5, where higher scores mean a better outcome).

    Measured: At 24 hours postoperatively.

  6. Block-Related Complications and Adverse Effects

    Evaluating the overall incidence of any block-related complications or adverse events (including block failure, local anesthetic systemic toxicity, hematoma, infection, pneumothorax, nerve injury, or magnesium-related side effects), reported as the percentage of affected patients out of the total study population

    Measured: Intraoperatively and throughout the 24-hour postoperative period.

  7. Incidence and Severity of Postoperative Nausea

    The incidence and severity of postoperative nausea will be assessed during the first 24 hours after surgery. Nausea severity will be measured using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no nausea) to 10 (worst imaginable nausea). Assessments will be performed at 2, 6, 12, and 24 hours postoperatively. The incidence of nausea (NRS > 0) and the severity scores at each assessment time will be recorded.

    Measured: During the first 24 hours postoperatively (Assessments will be performed at 2, 6, 12, and 24 hours postoperatively).

  8. Incidence and Frequency of Postoperative Vomiting

    The incidence and frequency of postoperative vomiting will be assessed during the first 24 hours after surgery. The occurrence of vomiting and the total number of vomiting episodes will be recorded at 2, 6, 12, and 24 hours postoperatively. The need for rescue antiemetic medication will also be documented.

    Measured: During the first 24 hours postoperatively (Assessments will be performed at 2, 6, 12, and 24 hours postoperatively).

  9. Intraoperative Fentanyl Requirements

    Measuring the total intraoperative consumption of fentanyl.

    Measured: Intraoperatively (during the surgical procedure).

  10. Heart rate

    Assessing heart rate values.

    Measured: At baseline, after block, every 15 minutes intraoperatively, and at the end of surgery (extubation period).

  11. Mean Arterial Pressure (MAP)

    Assessing Mean Arterial Pressure (MAP) values

    Measured: At baseline, after block, every 15 minutes intraoperatively, and at the end of surgery (extubation period).

  12. Oxygen Saturation (SpO2)

    Assessing peripheral oxygen saturation levels.

    Measured: At baseline, after block, every 15 minutes intraoperatively, and at the end of surgery (extubation period).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completionNov 2028 (estimated)
  4. Study completionNov 2028 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07923643
Sponsor's protocol ID
SECI-IRB 18-2026-850
Status last verified
Oct 2026
First submitted
24 Oct 2026
Last updated
6 Nov 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • He SQ, Liu GY, Yu YH, Wang L, Zhang GY, Peng DS, Bei WX, Chen CL, Lv SH, Zhao ZY, Huang Y, Xiang YQ. Establishing M1 subdivision for de novo nasopharyngeal carcinoma patients receiving immuno-chemotherapy: A multicenter, retrospective cohort study. Oral Oncol. 2024 Dec;159:107074. doi: 10.1016/j.oraloncology.2024.107074. Epub 2024 Oct 10.

    PubMed 39393309
  • Sun Y, Jacobson KB, Golovlev V. A multienzyme bioluminescent time-resolved pyrophosphate assay. Anal Biochem. 2007 Aug 15;367(2):201-9. doi: 10.1016/j.ab.2007.04.023. Epub 2007 Apr 25.

    PubMed 17540325
  • Norman G. Likert scales, levels of measurement and the "laws" of statistics. Adv Health Sci Educ Theory Pract. 2010 Dec;15(5):625-32. doi: 10.1007/s10459-010-9222-y. Epub 2010 Feb 10.

    PubMed 20146096
  • Guo L, Zhao J, She Z, Lu M, Zong Y. Statistical key factors optimization of conditions for hydrogen production from S-TE (solubilization by thermophilic enzyme) waste sludge. Bioresour Technol. 2013 Jun;137:51-6. doi: 10.1016/j.biortech.2013.03.102. Epub 2013 Mar 22.

    PubMed 23584408
  • Szalontai G, Besenyei G, Parkanyi L. Homonuclear SQ-DQ correlations in solids: applications of the broadband BaBa scheme to reveal 31P-31P spatial correlations in two-, three-, four-, and five-spin systems. Magn Reson Chem. 2011 Dec;49(12):801-11. doi: 10.1002/mrc.2842. Epub 2011 Nov 18.

    PubMed 22102509
  • Dinice J, Mainwaring RD. Pentalogy of Cantrell: a rare congenital abnormality. JAAPA. 2007 Nov;20(11):26-7. doi: 10.1097/01720610-200711000-00016. No abstract available.

    PubMed 18035760
  • Skjelbred P, Lokken P. Post-operative pain and inflammatory reaction reduced by injection of a corticosteroid. A controlled trial in bilateral oral surgery. Eur J Clin Pharmacol. 1982;21(5):391-6. doi: 10.1007/BF00542325.

    PubMed 7042372
  • Nowhere to hide. Nature. 2009 Jul 16;460(7253):307. doi: 10.1038/460307b. No abstract available.

    PubMed 19606096
  • Latham JA, Ji T, Matthews K, Mariano PS, Allen KN, Dunaway-Mariano D. Catalytic Mechanism of the Hotdog-Fold Thioesterase PA1618 Revealed by X-ray Structure Determination of a Substrate-Bound Oxygen Ester Analogue Complex. Chembiochem. 2017 Oct 5;18(19):1935-1943. doi: 10.1002/cbic.201700322. Epub 2017 Aug 30.

    PubMed 28741300
  • Houben JM, Giltay EJ, Rius-Ottenheim N, Hageman GJ, Kromhout D. Telomere length and mortality in elderly men: the Zutphen Elderly Study. J Gerontol A Biol Sci Med Sci. 2011 Jan;66(1):38-44. doi: 10.1093/gerona/glq164. Epub 2010 Oct 1.

    PubMed 20889650
  • Richebe P, Pouquet O, Jelacic S, Mehta S, Calderon J, Picard W, Rivat C, Cahana A, Janvier G. Target-controlled dosing of remifentanil during cardiac surgery reduces postoperative hyperalgesia. J Cardiothorac Vasc Anesth. 2011 Dec;25(6):917-25. doi: 10.1053/j.jvca.2011.03.185. Epub 2011 Jun 8.

    PubMed 21641819
  • McGreevy K, Bottros MM, Raja SN. Preventing Chronic Pain following Acute Pain: Risk Factors, Preventive Strategies, and their Efficacy. Eur J Pain Suppl. 2011 Nov 11;5(2):365-372. doi: 10.1016/j.eujps.2011.08.013.

    PubMed 22102847
  • Pawlas N, Broberg K, Skerfving S, Pawlas K. Disturbance of posture in children with very low lead exposure, and modification by VDR FokI genotype. Ann Agric Environ Med. 2014;21(4):739-44. doi: 10.5604/12321966.1129926.

    PubMed 25528913
  • Perl T, Carstens E, Hirn A, Quintel M, Vautz W, Nolte J, Junger M. Determination of serum propofol concentrations by breath analysis using ion mobility spectrometry. Br J Anaesth. 2009 Dec;103(6):822-7. doi: 10.1093/bja/aep312. Epub 2009 Nov 3.

    PubMed 19887534
  • Riechel C, Alegiani AC, Kopke S, Kasper J, Rosenkranz M, Thomalla G, Heesen C. Subjective and objective knowledge and decisional role preferences in cerebrovascular patients compared to controls. Patient Prefer Adherence. 2016 Aug 2;10:1453-60. doi: 10.2147/PPA.S98342. eCollection 2016.

    PubMed 27536077

Questions about this trial

What is this clinical trial studying?

A study testing Bupivacaine, Dexamethasone and Magnesium sulfate in people with Breast Cancer and Postoperative Pain, run by Assiut 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 10 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: opening soon, as of the sponsor's last update on 6 Nov 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Madona M Noman, MD (201006265867, madonamisheal90@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Recovery-15 score at 24 hours after surgery (time frame: 24 hours after surgery). 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 NCT07923643, which also lists 16 linked publications.

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 6 Nov 2026.

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