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

Phase 2

Completed

• Conditions: Spinal Anesthesia; Renal Cell Carcinoma; Pre- and Postoperative Analgesia
• Interventions: Drug: klonidin; Drug: epidural anesthesia

• Registration Number: NCT02030717
• Lead Sponsor: Umeå University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2014-01-07
• Study First Submitted QC: 2014-01-07
• Study First Posted: 2014-01-08
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-03
• Last Update Posted: 2015-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spinal anesthesia	klonidin	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)
Epidural anesthesia	epidural anesthesia	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.

Primary Outcome Measures

Name	Time	Method
postoperative mobilisation index	within the first 30 days (plus or minus 5 days) after surgery	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

Secondary Outcome Measures

Name	Time	Method
time of hospitalization	within the first 15 days after surgery	time in hospital after surgery until discharge

Trial Locations

Locations (1)

Umea University Hospital; 🇸🇪 Umea, Sweden