Randomized Study of Spinal Anesthesia Compared With Traditional Epidural Anesthesia Concerning Peroperative and Postoperative Pain After Open Nephrectomy in Patients With Renal Cell Carcinoma (ASA)

Umeå University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Pre- and Postoperative Analgesia; Spinal Anesthesia; Renal Cell Carcinoma

Treatments: Drug: klonidin; Drug: epidural anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT02030717

Dnr 151:2010/81099

2008-001491-77 (EudraCT Number)

Details and patient eligibility

About

The study aim to study whether spinal anesthesia (using: bupivacain, morfin och klonidin) can be better than epidural anesthesia during and after open surgery for renal cell carcinoma. Per- and postoperative pain after spinal anesthesia with klonidin can be reduced and, thus, shorten the hospital stay and rehabilitation of the patients.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• all patients in ASA score I - III, planned to be treated with open radical nephrectomy or nephron-sparing surgery having renal cell carcinoma

Exclusion criteria

• patients in ASA score IV-V,
• patients with advanced tumour thrombus in vena cava inferior,
• patients with high risk for bleeding
• patients with previous chronic pain symptoms
• patients having drug abuse
• patients having cognitive deficiencies or dementia disease
• patients with any contraindication of either spinal or epidural anesthesia
• patients younger than 18 years and pregnant woman
• patients having a weight less than 45 kg or weight over 120 kg

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Spinal anesthesia

Experimental group

Description:

The drugs used in the spinal injection are: 12 mg bupivacain, 160 ug morfin och klonidin( \< 60 years 75 ug, 60 - 85 years old 60 ug and older than 85 years 45 ug)

Treatment:

Drug: klonidin

Epidural anesthesia

Active Comparator group

Description:

Epidural anesthesia patients group gets an epidural catheter at level Th 8- 10 with per- and postoperative infusion with a routine mixture of: bupivacain 1 mg/ml, fentanyl 1 ug/ml, and adrenalin 1 ug/ml) until termination.

Treatment:

Drug: epidural anesthesia