drugset / Trial / NCT05829707

Long-term Outcomes of Breast Cancer Patients After Wound Infiltration Analgesia

NCT05829707

Phase 4 Completed 120 enrolled Osijek University Hospital
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2009-01-05
Primary completion
2012-12-31
Completion
2023-04-05

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Diclofenac Other / unclassified 50 mg Intravenous
Subject Levobupivacaine Other / unclassified 0.05 mg/kg Other
Subject Levobupivacaine Other / unclassified 0.5 mg/kg Other