An interventional study of Bupivacaine and Dexamethasone in Breast Cancer, Postoperative Pain and Chronic Postoperative Pain, sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Assiut University · Not applicable, Interventional, and Supportive care
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 60 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 mixed with 8mg dexamethasone (2ml) and diluted to 30ml with normal saline (13ml)
Drug: Bupivacaine · Drug: Dexamethasone
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 75mg mixed with 8mg dexamethasone (2ml),250mg magnesium sulfate (2.5ml) and diluted to 30ml with normal saline (10.5ml),
Drug: Bupivacaine · Drug: Dexamethasone · Drug: Magnesium sulfate
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
Dexamethasone 8 mg will be administered as an adjunct to the PECS block in both groups
Magnesium sulfate 250 mg will be administered as an adjunct to the PECS block in DM group only
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.
Time frame: 24 hours after surgery
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
Time frame: Through 6 months postoperatively
Postoperative Pain Intensity
Evaluating postoperative pain intensity using the Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain).
Time frame: At arrival to Post- Anesthesia Care Unit (PACU) (0 hour), 2, 4, 6, 12, and 24 hours postoperatively.
Total Postoperative Opioid Consumption
Measuring the total morphine consumption required by the patient as rescue analgesia.
Time frame: During the first 24 hours postoperatively
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).
Time frame: Within the first 24 hours postoperatively
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).
Time frame: At 24 hours postoperatively.
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
Time frame: Intraoperatively and throughout the 24-hour postoperative period.
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.
Time frame: During the first 24 hours postoperatively (Assessments will be performed at 2, 6, 12, and 24 hours postoperatively).
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.
Time frame: During the first 24 hours postoperatively (Assessments will be performed at 2, 6, 12, and 24 hours postoperatively).
Intraoperative Fentanyl Requirements
Measuring the total intraoperative consumption of fentanyl.
Time frame: Intraoperatively (during the surgical procedure).
Heart rate
Assessing heart rate values.
Time frame: At baseline, after block, every 15 minutes intraoperatively, and at the end of surgery (extubation period).
Mean Arterial Pressure (MAP)
Assessing Mean Arterial Pressure (MAP) values
Time frame: At baseline, after block, every 15 minutes intraoperatively, and at the end of surgery (extubation period).
Oxygen Saturation (SpO2)
Assessing peripheral oxygen saturation levels.
Time frame: At baseline, after block, every 15 minutes intraoperatively, and at the end of surgery (extubation period).
Start is estimated for Nov 2026; primary completion for Nov 2028, 24 months later.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 24 months is below that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Magnesium Sulfate