Studies in animals and retrospective studies in humans show that regional anesthesia reduces metastatic cancer dissemination. The investigators hypothesize that in patients suffering from malignant melanoma who have to undergo radical inguinal lymph node dissection immune function will be less compromised and long term survival will be superior when spinal anesthesia is compared to general anesthesia.
Results of basic science indicate that regional anesthesia prevents perioperative immunosuppression and reduces postoperative metastatic cancer dissemination. If this would occur in humans, optimised anesthetic management might improve long-term outcome after cancer surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
230
Spinal anesthesia with Bupivacaine hyperbar 0.5 %
General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane
Fachklinik Hornheide, Department of Anesthesiology, Intensive Care and Pain Therapy
Münster, Germany
RECRUITINGOverall survival
Time frame: five years
Changes of the total amount of immune cells
Change of the total amount of T-lymphocytes, B-lymphocytes, NK-cells, activity of NK-cells, changes in TGF-beta, activation status of thrombocytes from baseline until 15 minutes before end of surgery
Time frame: 15 minutes before end of surgery
Changes of the total amount of immune cells
Change of the total amount of T-lymphocytes, B-lymphocytes, NK-cells, activity of NK-cells, changes in TGF-beta, activation status of thrombocytes from baseline until 15 minutes before end of surgeryfrom baseline until 24 hours postoperatively
Time frame: 24 hours postoperatively
Changes of the total amount of immune cells
Change of the total amount of T-lymphocytes, B-lymphocytes, NK-cells, activity of NK-cells, changes in TGF-beta, activation status of thrombocytes from baseline until 15 minutes before end of surgeryfrom baseline until 24 hours postoperatively
Time frame: Five days postoperatively
Potential predictive biomarkers
Change of potential predictive biomarkers from baseline until 15 minutes before end of surgery postoperatively
Time frame: 15 minutes before end of surgery
Potential predictive biomarkers
Change of potential predictive biomarkers from baseline until 24 hours postoperatively
Time frame: 24 hours postoperatively
Potential predictive biomarkers
Change of potential predictive biomarkers from baseline until 5 days (plus or minus 1 day) postoperatively
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Five days postoperatively