An interventional study of Mirogabalin and Placebo in Breast Cancer and Post Operative Pain, sponsored by Cairo University. Not yet recruiting. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
This study aims to evaluate whether perioperative mirogabalin can reduce postoperative pain and morphine consumption in female patients undergoing modified radical mastectomy for breast cancer.
Postoperative pain is common after breast cancer surgery and may increase the need for opioid medications such as morphine. Although mirogabalin has been used to treat certain types of nerve pain, evidence regarding its effectiveness for acute postoperative pain remains limited.
This prospective, randomized, double-blind, placebo-controlled study will include 50 female patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status II or III who are scheduled for elective modified radical mastectomy at the National Cancer Institute, Cairo University.
Participants will be randomly allocated to one of two groups. The mirogabalin group will receive 15 mg orally approximately 2 hours before surgery and every 12 hours for 48 hours after surgery. The control group will receive matching placebo capsules on the same schedule. Both groups will receive standardized general anesthesia and multimodal postoperative analgesia, including paracetamol and ketorolac, when appropriate. Intravenous morphine will be administered as rescue analgesia according to a predefined protocol when the postoperative pain score reaches 4 or higher on a 0-10 visual analogue scale.
The primary outcome will be total intravenous morphine consumption during the first 24 hours after surgery. Secondary outcomes will include postoperative pain scores at rest and during movement, time to first rescue analgesia, the number of patients requiring morphine, postoperative nausea and vomiting, sedation, dizziness, respiratory safety, hemodynamic changes, recovery from anesthesia, patient satisfaction, and quality of recovery.
The study will assess whether adding mirogabalin to standard multimodal analgesia improves postoperative pain control and reduces opioid requirements without unacceptable adverse effects. The findings may help clarify the potential role of mirogabalin in perioperative pain management for patients undergoing breast cancer surgery.
Breast cancer surgery can be associated with moderate to severe acute postoperative pain, particularly after modified radical mastectomy, which involves removal of breast tissue and axillary lymph node dissection. Inadequate pain control may increase opioid consumption, contribute to opioid-related adverse effects, and interfere with early recovery.
Multimodal analgesia combines medications with different mechanisms of action to improve pain relief and reduce opioid requirements. Mirogabalin is an oral gabapentinoid that binds to the α2δ subunit of voltage-gated calcium channels and modulates excitatory neurotransmission. It has demonstrated efficacy in certain neuropathic pain conditions; however, evidence supporting its use for acute postoperative pain remains limited. Its potential analgesic benefit and safety in patients undergoing modified radical mastectomy therefore require further investigation.
This prospective, randomized, double-blind, placebo-controlled clinical trial will be conducted at the National Cancer Institute, Cairo University.
The study will enroll 50 adult female patients with breast cancer scheduled for elective modified radical mastectomy. Eligible participants will be 18-65 years old, have an ASA physical status of II or III, and have a body mass index greater than 20 and less than 35 kg/m². Patients with relevant medication hypersensitivity, current gabapentinoid treatment, chronic opioid use, significant chronic pain or neurological disorders, severe respiratory, cardiac, hepatic or renal disease, pregnancy, breastfeeding, or contraindications to the study medications will be excluded.
After obtaining written informed consent, participants will be randomly assigned in a 1:1 ratio to one of two groups using a computer-generated randomization sequence. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes. Identical study capsules will be prepared by personnel not involved in patient care or outcome assessment. Participants and the clinicians responsible for postoperative assessment will remain blinded to treatment allocation.
Both groups will receive standardized general anesthesia and multimodal analgesia. The anesthetic protocol will include propofol, fentanyl, rocuronium, and sevoflurane according to the study protocol. Paracetamol and intravenous ketorolac will be administered intraoperatively and continued postoperatively when clinically appropriate and not contraindicated. Regional anesthesia will not routinely be performed as part of the study protocol.
Postoperative pain will be assessed using a 0-10 visual analogue scale at rest and during movement at admission to the post-anesthesia care unit and at 1, 3, 6, 12, 18, and 24 hours after surgery. Intravenous morphine will be administered in 3 mg increments when the pain score reaches 4 or higher, with further doses given according to the predefined rescue analgesia protocol until adequate pain relief is achieved.
The primary outcome is total intravenous morphine consumption during the first 24 postoperative hours, expressed in milligrams.
Secondary outcomes include postoperative pain scores at rest and during movement, time to first rescue morphine administration, the proportion of patients requiring rescue morphine, the total number of rescue morphine doses, perioperative heart rate and mean arterial pressure, recovery from anesthesia, postoperative nausea and vomiting, sedation, dizziness, respiratory depression, oxygen desaturation, patient satisfaction with analgesia, and quality of recovery assessed using the 15-item Quality of Recovery questionnaire (QoR-15).
Potential adverse effects, particularly sedation, dizziness, and respiratory complications, will be monitored systematically. The study will compare the efficacy and safety of mirogabalin with placebo when both are added to standardized multimodal analgesia.
The results are expected to provide clinical information regarding the potential opioid-sparing effect of perioperative mirogabalin in patients undergoing modified radical mastectomy.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 50 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Cairo University is the lead sponsor of 4,907 studies on the registry; 1,445 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria
Participants will receive mirogabalin 15 mg orally approximately 2 hours before surgery, followed by 15 mg orally every 12 hours for 48 postoperative hours. All participants will receive standardized general anesthesia and multimodal analgesia, including paracetamol and ketorolac when appropriate. Intravenous morphine will be administered as rescue analgesia according to the study protocol.
Drug: Mirogabalin
Participants will receive matching placebo capsules approximately 2 hours before surgery and every 12 hours for 48 postoperative hours. All participants will receive the same standardized general anesthesia and multimodal analgesia as the mirogabalin group, with intravenous morphine administered as rescue analgesia according to the study protocol.
Drug: Placebo
Mirogabalin 15 mg administered orally approximately 2 hours before surgery, followed by 15 mg orally every 12 hours for 48 postoperative hours, as an adjunct to standardized multimodal analgesia.
Also known as: Tarlige
Matching placebo capsules administered orally approximately 2 hours before surgery and every 12 hours for 48 postoperative hours, according to the same schedule as the mirogabalin group.
Also known as: Matching placebo
Total Postoperative Morphine Consumption During the First 24 Hours
Total Postoperative Morphine Consumption During the First 24 Hours
Time frame: From completion of surgery until the first rescue morphine administration, assessed during the first 24 postoperative hours.
No study locations are listed for this record.
Plan to share: No — Individual participant data (IPD) will not be shared with other researchers. Patient confidentiality and privacy will be maintained in accordance with institutional policies and ethical approval requirements. The study data will be accessible only to authorized members of the research team. Requests for data access may be considered by the principal investigator and the institutional ethics committee, subject to applicable ethical and regulatory requirements.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jul 2027, 8 months later.
Of 2,272 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 69. This study's planned 8 months is below that.
Counting every sponsor, half of 2,345 studies reached it within 34 months; a quarter within 16 and three quarters within 69.
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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: Mirogabalin