Anesthesia and Cancer Recurrence im Malignant Melanoma

Not Applicable

• Conditions: Malignant Melanoma
• Interventions: Procedure: Spinal anesthesia with Bupivacaine hyperbar 0.5 %; Procedure: General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane

• Registration Number: NCT01588847
• Lead Sponsor: University Hospital Muenster

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-13
• Study First Submitted QC: 2012-04-30
• Study First Posted: 2012-05-01
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-10
• Last Update Posted: 2014-12-11
• Primary Completion: 2019-03
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

• Patients scheduled for inguinal lymph node dissection because of malignant melanoma of the lower limb
• Signed informed consent

Exclusion Criteria

• Age < 18 years
• Female patients who are pregnant or nursing
• Multiple organ failure
• Contraindications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regional anesthesia	Spinal anesthesia with Bupivacaine hyperbar 0.5 %	-
General anesthesia	General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane	-

Primary Outcome Measures

Name	Time	Method
Overall survival	five years

Secondary Outcome Measures

Name	Time	Method
Potential predictive biomarkers	Five days postoperatively	Change of potential predictive biomarkers from baseline until 5 days (plus or minus 1 day) postoperatively
Changes of the total amount of immune cells	Five days postoperatively	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

Trial Locations

Locations (1)

Fachklinik Hornheide, Department of Anesthesiology, Intensive Care and Pain Therapy; 🇩🇪 Münster, Germany