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)

June 3, 2015 updated by: Umeå University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Umea, Sweden, 901 85
        • Umea University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative mobilisation index
Time Frame: 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
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 Frame: within the first 15 days after surgery
time in hospital after surgery until discharge
within the first 15 days after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need of rescue analgetics
Time Frame: within the first 15 days after surgery
the total amount of analgetics used besides the spinal infusion or the epidural infusion used
within the first 15 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Collaborators

University Hospital, Umeå

Investigators

  • Study Chair: Borje Ljungberg, MD, PhD, Umeå University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

January 7, 2014

First Submitted That Met QC Criteria

January 7, 2014

First Posted (Estimate)

January 8, 2014

Study Record Updates

Last Update Posted (Estimate)

June 4, 2015

Last Update Submitted That Met QC Criteria

June 3, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dnr 151:2010/81099
  • 2008-001491-77 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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