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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 (ASA)

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
klonidin
epidural anesthesia
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pre- and Postoperative Analgesia focused on measuring Spinal anesthesia, Epidural anesthesia, Klonidin, renal cell carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Umea University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Spinal anesthesia

Epidural anesthesia

Arm 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)

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

time of hospitalization
time in hospital after surgery until discharge

Full Information

First Posted
January 7, 2014
Last Updated
June 3, 2015
Sponsor
Umeå University
Collaborators
University Hospital, Umeå
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1. Study Identification

Unique Protocol Identification Number
NCT02030717
Brief Title
Randomized Study of Spinal Anesthesia Compared With Traditional Epidural Anesthesia Concerning Peroperative and Postoperative Pain After Open Nephrectomy in Patients With Renal Cell Carcinoma
Acronym
ASA
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Umeå University
Collaborators
University Hospital, Umeå

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre- and Postoperative Analgesia, Spinal Anesthesia, Renal Cell Carcinoma
Keywords
Spinal anesthesia, Epidural anesthesia, Klonidin, renal cell carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spinal anesthesia
Arm Type
Experimental
Arm 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)
Arm Title
Epidural anesthesia
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
klonidin
Other Intervention Name(s)
Brand name: Duraclon - FDA Apl No (NDA) 020615.
Intervention Description
spinal injection of 12 mg bupivacain,160 ug morfin och klonidin, according to age
Intervention Type
Drug
Intervention Name(s)
epidural anesthesia
Intervention Description
epidural anesthesia: patients get an continuous infusion of a solution with bupivacain 1 mg/ml, fentanyl 1 ug/ml and adrenalin 1 ug/ml
Primary Outcome Measure Information:
Title
postoperative mobilisation index
Description
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
Time Frame
within the first 30 days (plus or minus 5 days) after surgery
Secondary Outcome Measure Information:
Title
time of hospitalization
Description
time in hospital after surgery until discharge
Time Frame
within the first 15 days after surgery
Other Pre-specified Outcome Measures:
Title
Need of rescue analgetics
Description
the total amount of analgetics used besides the spinal infusion or the epidural infusion used
Time Frame
within the first 15 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Borje Ljungberg, MD, PhD
Organizational Affiliation
Umea University
Official's Role
Study Chair
Facility Information:
Facility Name
Umea University Hospital
City
Umea
ZIP/Postal Code
901 85
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
36177827
Citation
Thurm M, Hultin M, Johansson G, Dahlin BI, Winso O, Ljungberg B. Spinal anaesthesia with clonidine: pain relief and earlier mobilisation after open nephrectomy - a randomised clinical trial. J Int Med Res. 2022 Sep;50(9):3000605221126883. doi: 10.1177/03000605221126883.
Results Reference
derived

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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

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