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Does Thoracic Epidural Analgesia Influence Urinary Micturition by Patients Undergoing Thoracic Surgery?

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00976313
First Posted: September 14, 2009
Last Update Posted: June 9, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital Inselspital, Berne
  Purpose

Under the influence of epidural analgesia, patients may not feel the urge to urinate, which can result in urinary retention and bladder overdistension.

The use of a transurethral catheter is associated with significant morbidity such as patient discomfort, urinary tract infections, urethral trauma and stricture.

Urodynamic changes under thoracic epidural anaesthesia are still unknown. The aim of this study is to compare lower urinary tract function before and during thoracic epidural analgesia within segments T2 to T10 for postoperative pain treatment in patients undergoing thoracotomy or sternotomy.


Condition Intervention
Thoracotomy Sternotomy Procedure: Assessment of urinary micturition after thoracotomy Other: International Prostate Symptom Score

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does Thoracic Epidural Analgesia Influence Urinary Micturition by Patients Undergoing Thoracic Surgery? An Observational, Prospective Study

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Differences in postvoid residual urine volume before and during thoracic epidural analgesia [ Time Frame: 3 days ]

Secondary Outcome Measures:
  • Voided volume [ Time Frame: 3 days ]
  • Maximum bladder capacity [ Time Frame: 3 days ]
  • Bladder sensitivity (yes/no) at strong desire to void [ Time Frame: 3 days ]

Enrollment: 26
Study Start Date: September 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
male patients
Procedure: Assessment of urinary micturition after thoracotomy
Post residual urine volume and voided volume will be assessed with Bladder Scan™ BVI 6100 (Bladder scan, Bothell, WA, USA) will be performed the day before surgery and on day 2 after surgery, with epidural analgesia within segments T2-4 to T10 21,22. Bladder sensitivity will be assessed at strong desire to void. On day 2 the bladder will be filled through the transurethral catheter till the patient signalised a strong desire to void, then the catheter will be removed and spontaneous micturition will be attempted. Voided volume and post void residual will be assessed.
Other: International Prostate Symptom Score
International Prostate Symptom Score (IPSS) for assessment of lower urinary tract symptoms (LUTS) preoperatively
2
female patients
Procedure: Assessment of urinary micturition after thoracotomy
Post residual urine volume and voided volume will be assessed with Bladder Scan™ BVI 6100 (Bladder scan, Bothell, WA, USA) will be performed the day before surgery and on day 2 after surgery, with epidural analgesia within segments T2-4 to T10 21,22. Bladder sensitivity will be assessed at strong desire to void. On day 2 the bladder will be filled through the transurethral catheter till the patient signalised a strong desire to void, then the catheter will be removed and spontaneous micturition will be attempted. Voided volume and post void residual will be assessed.
Other: International Prostate Symptom Score
International Prostate Symptom Score (IPSS) for assessment of lower urinary tract symptoms (LUTS) preoperatively

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
male and female patients undergoing thoracotomy or sternotomy
Criteria

Inclusion Criteria:

  • Written informed consent
  • Thoracic surgery including thoracotomy and sternotomy
  • Thoracic epidural analgesia

Exclusion Criteria

  • Contraindications to epidural anesthesia or refusal
  • Preoperative residual urine volume > 100ml
  • International Prostate Symptom Score (IPSS) > 7
  • Pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00976313


Locations
Switzerland
Dep of anesthesiology and pain treatment, Bern University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Patrick Y Wuethrich, MD Dep of Anesthesiologiy and Pain treatment, University Hospital Bern, 3010 Bern, Switzerland
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Patrick Y. Wuethrich, Universitätsklink für Anästhesiologie und Schmerztherapie, Inselspital, Bern, Switzerland
ClinicalTrials.gov Identifier: NCT00976313     History of Changes
Other Study ID Numbers: 171/09
First Submitted: September 11, 2009
First Posted: September 14, 2009
Last Update Posted: June 9, 2010
Last Verified: June 2010

Keywords provided by University Hospital Inselspital, Berne:
thoracic epidural analgesia
urinary micturition
thoracotomy