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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pre- and Postoperative Analgesia, Spinal Anesthesia, Renal Cell Carcinoma

Intervention / Treatment
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* Drug: klonidin
* Drug: epidural anesthesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal anesthesia<br>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) | Drug: klonidin<br>* spinal injection of 12 mg bupivacain,160 ug morfin och klonidin, according to age<br>* Other names: Brand name: Duraclon - FDA Apl No (NDA) 020615.;|
| Active Comparator: Epidural anesthesia<br>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. | Drug: epidural anesthesia<br>* epidural anesthesia: patients get an continuous infusion of a solution with bupivacain 1 mg/ml, fentanyl 1 ug/ml and adrenalin 1 ug/ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative mobilisation index | Using a number of variables an index of mobilisation has been created; eg pain (10 graded scale), malaise, intravenous substitution, eating in dining room, Walking outside ward room, passage of stool, carrying urinary bladder catheter, can mobilise out of bed without help | within the first 30 days (plus or minus 5 days) after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time of hospitalization | time in hospital after surgery until discharge | within the first 15 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal anesthesia, Epidural anesthesia, Klonidin, renal cell carcinoma