Anesthesia and Cancer Recurrence im Malignant Melanoma

University Hospital Muenster

Status: Unknown

Conditions: Malignant Melanoma

Treatments: Procedure: Spinal anesthesia with Bupivacaine hyperbar 0.5 %; Procedure: General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT01588847

02-AnIt-11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 230 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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230 participants in 2 patient groups

Regional anesthesia

Experimental group

Treatment:

Procedure: Spinal anesthesia with Bupivacaine hyperbar 0.5 %

General anesthesia

Active Comparator group

Treatment:

Procedure: General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane