Mastectomy, Modified RadicalPhase 3NCT07257874
Intraoperative Pectoral Block vs IV Analgesia for Pain After Modified Radical Mastectomy
A Phase 3 study testing bupivacaine 0.5% injection and Ketorolac 30 mg IV in people with Mastectomy, Modified Radical, run by Islamabad Medical and Dental College at 1 site in Pakistan.
Trial summary
There is difference in post operative pain between patients receiving inter- pectoral block and those receiving standard Intravenous analgesia(INJ TORADOL) in patients undergoing Modified Radical Mastectomy. To compare between these two methods , which one is better for post operative pain management. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Mastectomy, Modified Radical
- What is being tested?
- bupivacaine 0.5% injection and Ketorolac 30 mg IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2025to 15 Dec 2025
- Phase
- Phase 3
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female Patients undergoing Modified Radical Mastectomy for biopsy proven Carcinoma Breast
- Patient with age 18-65 years
- Patients with ASA Grade 2
- BMI less than 40 kg/meter square
Who cannot join
- Block site infection
- Coagulopathies (INR > 1.6 and Platelets < 100000)
- Any Organ dysfunction such as severe cardiac, pulmonary, renal or liver dysfunction
- Systemic infection
- Dementia
- Known hypersensitivity to local anesthetic agents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Intra-Operative Pectoral Block and Intravenous Analgesia for Post-Operative Pain Relief in Patients Undergoing Modified Radical Mastectomy
There is difference in post operative pain between patients receiving inter- pectoral block and those receiving standard Intravenous analgesia(INJ TORADOL) in patients undergoing Modified Radical Mastectomy.
To compare between these two methods , which one is better for post operative pain management.
- Conditions
- Mastectomy, Modified Radical
- Being tested
- bupivacaine 0.5% injection, Ketorolac 30 mg IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivacaine 0.5% injectionDrug
Intra-Operative Pectoral Block in Patients Undergoing Modified Radical Mastectomy for Post operative Pain management
Ketorolac 30 mg IVDrug
Ketorolac 30mg administered Intravenously as a standard practice for post operative pain management in modified radical mastectomy
| Study group | Role | What they receive |
|---|---|---|
| PECs Arm | Experimental | Not described Receives: Drug: bupivacaine 0.5% injection |
| IV Analgesia Arm | Active comparator | Not described Receives: Drug: Ketorolac 30 mg IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Severity at 24 hours Measured by Numeric Pain Rating Scale from 0-10 , where 0 is no pain and 10 is severe pain.
Measured: 24 hours Post Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Jul 2025
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mastectomy, Modified RadicalStudies 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Islamabad Medical and Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257874
- Sponsor's protocol ID
- No.179/IMDC/IREB-2025
- Status last verified
- May 2026
- First submitted
- 19 Nov 2025
- Last updated
- 15 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Intra-Operative Pectoral Block and Intravenous Analgesia for Post-Operative Pain Relief in Patients Undergoing Modified Radical Mastectomy
- ClinicalTrials.gov ID
- NCT07257874
- Acronym / sponsor ID
- No.179/IMDC/IREB-2025
- Conditions
- Mastectomy, Modified Radical
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Islamabad Medical and Dental CollegeUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 2 Dec 2025 (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.
There is difference in post operative pain between patients receiving inter- pectoral block and those receiving standard Intravenous analgesia(INJ TORADOL) in patients undergoing Modified Radical Mastectomy.
To compare between these two methods , which one is better for post operative pain management.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PECs Arm | Experimental | Drug: bupivacaine 0.5% injection |
| IV Analgesia Arm | Active comparator | Drug: Ketorolac 30 mg IV |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female Patients undergoing Modified Radical Mastectomy for biopsy proven Carcinoma Breast
- Patient with age 18-65 years
- Patients with ASA Grade 2
- BMI less than 40 kg/meter square
Key exclusion criteria (6 listed)
- Block site infection
- Coagulopathies (INR > 1.6 and Platelets < 100000)
- Any Organ dysfunction such as severe cardiac, pulmonary, renal or liver dysfunction
- Systemic infection
- Dementia
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 |
|---|---|---|
| bupivacaine 0.5% injectionIntra-Operative Pectoral Block in Patients Undergoing Modified Radical Mastectomy for Post operative Pain management | Drug | PECs Arm |
| Ketorolac 30 mg IVKetorolac 30mg administered Intravenously as a standard practice for post operative pain management in modified radical mastectomy | Drug | IV Analgesia Arm |
Primary outcome
Postoperative Pain Severity at 24 hours Measured by Numeric Pain Rating Scale from 0-10 , where 0 is no pain and 10 is severe pain.
Time frame: 24 hours Post Surgery
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 15 May 2026.
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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. 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 Phase 3 study testing bupivacaine 0.5% injection and Ketorolac 30 mg IV in people with Mastectomy, Modified Radical, run by Islamabad Medical and Dental College 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 4 inclusion and 6 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 15 May 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Postoperative Pain Severity at 24 hours Measured by Numeric Pain Rating Scale from 0-10 , where 0 is no pain and 10 is severe pain. (time frame: 24 hours Post Surgery). 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 15 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.