Long-term Outcomes of Breast Cancer Patients After Wound Infiltration Analgesia (NCT05829707) | Clinical Trial Compass
CompletedPhase 4
Long-term Outcomes of Breast Cancer Patients After Wound Infiltration Analgesia
120 participantsStarted 2009-01-05
Plain-language summary
In the study that was conducted from 05.01.2009 - 31.12.2012. 120 patients were examined. By drawing random numbers, the patients were randomized into 3 groups for postoperative analgesia:
1. Diclofenac 2 mg/kg/day - control,
2. Wound infiltration via wound catheter with catheter tip placed in the axilla, 3\*0.5 mg/kg 0.5% levobupivacaine bolus dose.
3. 0.05 mg/kg/h 0.5% levobupivacaine continuously via wound infiltration catheter with catheter tip placed in the axilla. The drug was delivered using a PCA pump for 24 hours.
The aim was to compare early postoperative outcomes - pain control on a visual analog scale of 1-10, hand grip strength, and quality of life after surgery and after 1 year.
Long-term survival was examined subsequently, from the hospital register.
Who can participate
Age range
30 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Breast cancer patients whose disease requires axillary lymph node dissection
* who consented to participate in the study
* aged 30 - 75
* The patient is able to understand all three methods of analgesia
* Patients can receive any of the study drugs
* Able to understand and complete questionnaires on quality of life and shoulder pain
Exclusion Criteria:
* Age \<30 years - \>75 years
* Patients who refused to participate in the study (at any stage of the study)
* Patients who after histological analysis did not require axillary lymph node dissection
* Patients with known intolerance to study drugs
* Patients who unintentionally removed wound infiltration catheters.
* Patients who required surgical reintervention during the study period
* Patients having adverse reactions to any study drug.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postoperative analgesia
Timeframe: from 1-4 days postoperative, day of surgery is day 1
2
Hand grip strength
Timeframe: Before surgery, on day 4 after surgery, and one year after surgery
3
Shoulder disability
Timeframe: Before surgery and after one year at surgical control.
4
Health related quality of life
Timeframe: Before surgery and after one year at surgical control.