Pain, PostoperativePhase 4NCT03799757
Using Bupivacaine Locally in the Mastectomy Drains to Control Postoperative Pain
A Phase 4 study testing 40ml of 0.25% bupivacaine and 40ml of 0.9% normal saline in people with Pain, Postoperative and Breast Cancer, run by Alexandria University at 1 site in Egypt.
Trial summary
in this study we are investigating the role of instillation of Bupivacaine through surgical drains at the end of mastectomy surgeries in controlling post operative pain and decreasing their pain killers requirement in the early postoperative period Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Pain, Postoperative, Breast Cancer
- What is being tested?
- 40ml of 0.25% bupivacaine and 40ml of 0.9% normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2016to Dec 2018
- Phase
- Phase 4
- 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 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female patients with unilateral breast cancer candidates for total mastectomy and axillary dissection
Who cannot join
- Male patients
- Bilateral breast cancer.
- Patients with a history of a long duration of NSAID intake or other painkillers, drug abuse
- Patients with chest wall pain like Tietze syndrome, history of angina pectoris or recent HZV infection.
- Patients with known psychological or mental problems.
- Patients who were not exposed to axillary dissection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Wound Installation With Bupivacaine Through Surgical Drains in Postoperative Analgesia in Modified Radical Mastectomy
in this study we are investigating the role of instillation of Bupivacaine through surgical drains at the end of mastectomy surgeries in controlling post operative pain and decreasing their pain killers requirement in the early postoperative period
Read the detailed description
patients were enrolled into 2 groups. in one group the wound was installed by 40ml of 0.25% bupivacaine through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes.
in the other group the wound was installed by 40ml of 0.9% normal saline through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes. (placebo group) patients and health care providers were blinded as regard the study group patients enrolled in. Visual Analog Pain Scale which is a score for detection of how much the patient is annoyed from the pain- was assessed two and four hours post-operative then every four hours thereafter.
- Conditions
- Pain, Postoperative, Breast Cancer
- Being tested
- 40ml of 0.25% bupivacaine, 40ml of 0.9% normal saline
- Keywords
- bupivacaine, Post-mastectomy acute pain, Wound instillation
- Medical subject headings
- Pain, Postoperative, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40ml of 0.25% bupivacaineDrug
40ml of 0.9% normal salineDrug
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine | Active comparator | The wound was installed by 40ml of 0.25% bupivacaine through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes. Receives: Drug: 40ml of 0.25% bupivacaine |
| Placebo | Placebo comparator | The wound was installed by 40ml of 0.9% normal saline through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes. (placebo group) Receives: Drug: 40ml of 0.9% normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue pain score
The intensity of pain will be assessed by the VAS score
Measured: first 24 hours
Number of demands for analgesic
How many times the patient will require analgesics
Measured: First 24 hours
Timing of first demand for analgesic
Time lapse between recovery from surgery and first demand for analgesic
Measured: First 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study startJan 2016
- Primary completionNov 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Alexandria 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud A. Alhussini, Alexandria University
- Investigators
- Mahmoud A Alhussini, md, Principal investigator, faculty of medicine , univeristy of alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799757
- Sponsor's protocol ID
- malhussini001
- Status last verified
- Jan 2019
- First submitted
- 6 Jan 2019
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Wound Installation With Bupivacaine Through Surgical Drains in Postoperative Analgesia in Modified Radical Mastectomy
- ClinicalTrials.gov ID
- NCT03799757
- Acronym / sponsor ID
- malhussini001
- Conditions
- Pain, Postoperative, Breast Cancer
- Keywords
- bupivacaine, Post-mastectomy acute pain, Wound instillation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 10 Jan 2019 (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.
in this study we are investigating the role of instillation of Bupivacaine through surgical drains at the end of mastectomy surgeries in controlling post operative pain and decreasing their pain killers requirement in the early postoperative period
Detailed description
patients were enrolled into 2 groups. in one group the wound was installed by 40ml of 0.25% bupivacaine through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes.
in the other group the wound was installed by 40ml of 0.9% normal saline through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes. (placebo group) patients and health care providers were blinded as regard the study group patients enrolled in. Visual Analog Pain Scale which is a score for detection of how much the patient is annoyed from the pain- was assessed two and four hours post-operative then every four hours thereafter.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine | Active comparator | Drug: 40ml of 0.25% bupivacaineThe wound was installed by 40ml of 0.25% bupivacaine through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes. |
| Placebo | Placebo comparator | Drug: 40ml of 0.9% normal salineThe wound was installed by 40ml of 0.9% normal saline through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes. (placebo group) |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- female patients with unilateral breast cancer candidates for total mastectomy and axillary dissection
Key exclusion criteria (6 listed)
- Male patients
- Bilateral breast cancer.
- Patients with a history of a long duration of NSAID intake or other painkillers, drug abuse
- Patients with chest wall pain like Tietze syndrome, history of angina pectoris or recent HZV infection.
- Patients with known psychological or mental problems.
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 |
|---|---|---|
| 40ml of 0.25% bupivacaine | Drug | Bupivacaine |
| 40ml of 0.9% normal saline | Drug | Placebo |
Primary outcome
Visual analogue pain score
Time frame: first 24 hours
The intensity of pain will be assessed by the VAS score
Number of demands for analgesic
Time frame: First 24 hours
How many times the patient will require analgesics
Timing of first demand for analgesic
Time frame: First 24 hours
Time lapse between recovery from surgery and first demand for analgesic
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 10 Jan 2019.
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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.
Mahmoud A Alhussini, md principal investigator
faculty of medicine , univeristy of alexandria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 40ml of 0.25% bupivacaine and 40ml of 0.9% normal saline in people with Pain, Postoperative and Breast Cancer, run by Alexandria University at 1 site in Egypt.
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 1 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 10 Jan 2019. 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Visual analogue pain score (time frame: first 24 hours). The study lists 3 primary outcomes in all. 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 10 Jan 2019.