Long-term Outcomes of Breast Cancer Patients After Wound Infiltration Analgesia
CompletedPhase 4NCT05829707
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Long-term Outcomes of Breast Cancer Patients Receiving Levobupivacaine Wound Infiltration or Diclofenac for Postoperative Pain Relief
- Conditions
- Postoperative Analgesia
- Hand Strength
- Health Related Quality of Life
- Chronic Shoulder Pain
- Breast Cancer Female
- Surgical Wound Infiltration
- Lymph Node Dissection
- Interventions
- Drug: Diclofenac Sodium
- Drug: Levobupivacaine bolus analgesia
- Drug: Levobupivacaine PCA group
- Sponsor
- Osijek University Hospital
- Start date
- 2009-01-05
- Primary completion
- 2012-12-31
- Sex
- Female
- Age range
- from 30 Years to 75 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05829707