Breast CancerNCT07320781
Role of Preoperative Tapentadol in Reduction of Perioperative Analgesic Requirement After Breast Conservative Surgery in Cancer Patients.
A study testing Tapentadol in people with Breast Cancer, run by Shaukat Khanum Memorial Cancer Hospital & Research Centre at 1 site in Pakistan.
Trial summary
This study evaluated the preemptive analgesic efficacy of Tapentadol in reducing peri operative analgesic requirements among patients undergoing breast cancer surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tapentadol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Nov 2024to 10 Oct 2025
- Phase
- Interventional
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18-60 years
- ASA 1,2,3
- Patients scheduled for breast conservation surgery -
Who cannot join
- Patient refusal
- CKD greater than 3
- BMI greater than 35
- Known drug allergy -
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluated the preemptive analgesic efficacy of Tapentadol in reducing peri operative analgesic requirements among patients undergoing breast cancer surgery.
Read the detailed description
A double blinded prospective RCT was conducted with 70 patients undergoing breast cancer surgery with 35 patients being studied with Administrated drug \& other 35 as placebo. Intraoperative \& postoperative morphine consumption was calculated and documented.
- Conditions
- Breast Cancer
- Being tested
- Tapentadol, Placebo
- Keywords
- Tapentadol, Breast Cancer Surgery, Morphine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TapentadolDrug
75 mg oral tapentadol given 1 hour before surgery in control group and placebo tablet was given in Group B. Intraoperative and post operative morphine consumption and pain scores at 1,2,3,4 hours were calculated.
PlaceboOther
Placebo tablet was given in group B.
| Study group | Role | What they receive |
|---|---|---|
| Tapentadol | Active comparator | Control drug (Tapentadol ) Receives: Drug: Tapentadol |
| Placebo | Placebo comparator | Placebo sodium bicarbonate/ peppermint oil tablet Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative and postoperative morphine consumption
During the course of surgery and up to 4 hours surgery Intraoperative and postoperative morphine consumption.
Measured: During the course of surgery and up to 4 hours surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start15 Nov 2024
- Primary completion30 Sep 2025
- Study completion10 Oct 2025
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Allah Ditta Ashfaq, Study director, Shaukat Khanam Memorial Cancer Hospital & Research Centre LAHORE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07320781
- Sponsor's protocol ID
- IRB-23-20
- Status last verified
- Jan 2026
- First submitted
- 21 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD. Due to confidentiality of patients data.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Preoperative Tapentadol in Reduction of Perioperative Analgesic Requirement After Breast Conservative Surgery in Cancer Patients.
- ClinicalTrials.gov ID
- NCT07320781
- Acronym / sponsor ID
- IRB-23-20
- Conditions
- Breast Cancer
- Keywords
- Tapentadol, Breast Cancer Surgery, Morphine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research CentreUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 6 Jan 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 evaluated the preemptive analgesic efficacy of Tapentadol in reducing peri operative analgesic requirements among patients undergoing breast cancer surgery.
Detailed description
A double blinded prospective RCT was conducted with 70 patients undergoing breast cancer surgery with 35 patients being studied with Administrated drug \& other 35 as placebo. Intraoperative \& postoperative morphine consumption was calculated and documented.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Tapentadol | Active comparator | Drug: TapentadolControl drug (Tapentadol ) |
| Placebo | Placebo comparator | Other: PlaceboPlacebo sodium bicarbonate/ peppermint oil tablet |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-60 years
- ASA 1,2,3
- Patients scheduled for breast conservation surgery -
Key exclusion criteria (4 listed)
- Patient refusal
- CKD greater than 3
- BMI greater than 35
- Known drug allergy -
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 |
|---|---|---|
| Tapentadol75 mg oral tapentadol given 1 hour before surgery in control group and placebo tablet was given in Group B. Intraoperative and post operative morphine consumption and pain scores at 1,2,3,4 hours were calculated. | Drug | Tapentadol |
| PlaceboPlacebo tablet was given in group B. | Other | Placebo |
Primary outcome
Intraoperative and postoperative morphine consumption
Time frame: During the course of surgery and up to 4 hours surgery
During the course of surgery and up to 4 hours surgery Intraoperative and postoperative morphine consumption.
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 8 Jan 2026.
- Individual participant dataSharing planned: No. No plan to share IPD. Due to confidentiality of patients data.
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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.
Dr. Allah Ditta Ashfaq study director
Shaukat Khanam Memorial Cancer Hospital & Research Centre LAHORE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tapentadol in people with Breast Cancer, run by Shaukat Khanum Memorial Cancer Hospital & Research Centre 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 3 inclusion and 4 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 8 Jan 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. Some participants in this study may receive a placebo. 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?
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?
Intraoperative and postoperative morphine consumption (time frame: During the course of surgery and up to 4 hours 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 8 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.