Breast CancerNCT07880821
Perioperative Mirogabalin for Pain Relief After Modified Radical Mastectomy
A study testing Mirogabalin in people with Breast Cancer and Post Operative Pain, run by Cairo University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer, Post Operative Pain
- What is being tested?
- Mirogabalin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 1 Aug 2027
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients with breast cancer scheduled for elective modified radical mastectomy.
- American Society of Anesthesiologists (ASA) physical status II or III.
- Age between 18 and 65 years, inclusive.
- Body mass index (BMI) >20 and <35 kg/m².
- Ability to understand and reliably use the visual analogue scale (VAS) for pain assessment.
- Provision of written informed consent before enrollment.
Who cannot join
- Refusal to participate or withdrawal of consent.
- ASA physical status IV.
- BMI <20 or >35 kg/m².
- Known hypersensitivity, contraindication, or intolerance to mirogabalin, morphine, paracetamol, ketorolac, or other medications included in the study protocol.
- Current treatment with gabapentin, pregabalin, or mirogabalin.
- Chronic opioid use or regular analgesic therapy for chronic pain.
Show all 12Show fewer
- History of chronic pain or significant neurological disease that could interfere with postoperative pain assessment.
- Significant psychological or psychiatric disorders that could affect pain assessment, communication, or study compliance.
- Severe respiratory, cardiac, hepatic, or renal disease.
- Any contraindication to the study medications or standardized anesthetic protocol.
- Pregnancy or breastfeeding.
- Requirement for regional anesthesia or a major modification of the standardized anesthetic protocol.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Perioperative Mirogabalin on Acute Postoperative Pain and Opioid Consumption Following Modified Radical Mastectomy: A Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
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.
- Intervention group:** Participants will receive mirogabalin 15 mg orally approximately 2 hours before surgery, followed by 15 mg orally every 12 hours for 48 postoperative hours.
- Control group:** Participants will receive matching placebo capsules according to the same schedule.
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.
- Conditions
- Breast Cancer, Post Operative Pain
- Being tested
- Mirogabalin, Placebo
- Keywords
- pain, mirogabalin, placebo
- Medical subject headings
- Breast Neoplasms, Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirogabalinDrug
Also called Tarlige
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.
PlaceboDrug
Also called Matching placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| Mirogabalin Group | Experimental | 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. Receives: Drug: Mirogabalin |
| Placebo Group | Experimental | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Postoperative Morphine Consumption During the First 24 Hours
Total Postoperative Morphine Consumption During the First 24 Hours
Measured: From completion of surgery until the first rescue morphine administration, assessed during the first 24 postoperative hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Model description
- Two-arm, parallel-group, randomized, double-blind, placebo-controlled study comparing perioperative mirogabalin with matching placebo.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sayed Mahmoud Abed, Cairo University
- Investigators
- Sayed Abed, MD, Principal investigator, Assistant professor of anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880821
- Sponsor's protocol ID
- Mirogabalin in MRM
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Mirogabalin on Acute Postoperative Pain and Opioid Consumption Following Modified Radical Mastectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07880821
- Acronym / sponsor ID
- Mirogabalin in MRM
- Conditions
- Breast Cancer, Post Operative Pain
- Keywords
- pain, mirogabalin, placebo
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 19 Oct 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.
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.
Detailed description
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.
- Intervention group:** Participants will receive mirogabalin 15 mg orally approximately 2 hours before surgery, followed by 15 mg orally every 12 hours for 48 postoperative hours.
- Control group:** Participants will receive matching placebo capsules according to the same schedule.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm, parallel-group, randomized, double-blind, placebo-controlled study comparing perioperative mirogabalin with matching placebo.
| Arm | Type | Receives |
|---|---|---|
| Mirogabalin Group | Experimental | Drug: MirogabalinParticipants 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. |
| Placebo Group | Experimental | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female patients with breast cancer scheduled for elective modified radical mastectomy.
- American Society of Anesthesiologists (ASA) physical status II or III.
- Age between 18 and 65 years, inclusive.
- Body mass index (BMI) >20 and <35 kg/m².
- Ability to understand and reliably use the visual analogue scale (VAS) for pain assessment.
Key exclusion criteria (12 listed)
- Refusal to participate or withdrawal of consent.
- ASA physical status IV.
- BMI <20 or >35 kg/m².
- Known hypersensitivity, contraindication, or intolerance to mirogabalin, morphine, paracetamol, ketorolac, or other medications included in the study protocol.
- Current treatment with gabapentin, pregabalin, or mirogabalin.
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 |
|---|---|---|
| MirogabalinAlso: TarligeMirogabalin 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. | Drug | Mirogabalin Group |
| PlaceboAlso: Matching placeboMatching 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. | Drug | Placebo Group |
Primary outcome
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.
Total Postoperative Morphine Consumption During the First 24 Hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: 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.
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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.
Sayed Abed, MD principal investigator
Assistant professor of anesthesia
Questions about this trial
What is this clinical trial studying?
A study testing Mirogabalin in people with Breast Cancer and Post Operative Pain, run by Cairo University.
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 6 inclusion and 12 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 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Sayed M Abed, MD (+201226806532, sayed.abed@nci.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). 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 19 Oct 2026.