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

This study has been completed.
Sponsor:
Collaborators:
Universitätsklink für Anästhesiologie und Schmerztherapie, Inselspital, Bern, Switzerland
Universitätsklink für Thoraxchirurgie, Inselspital, Bern, Switzerland
Urologische Universitätsklinik, Inselspital, Bern, Switzerland
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00976313
First received: September 11, 2009
Last updated: June 8, 2010
Last verified: June 2010
History of Changes
  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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00976313

Locations
Switzerland
Dep of anesthesiology and pain treatment, Bern University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Universitätsklink für Anästhesiologie und Schmerztherapie, Inselspital, Bern, Switzerland
Universitätsklink für Thoraxchirurgie, Inselspital, Bern, Switzerland
Urologische Universitätsklinik, Inselspital, Bern, Switzerland
Investigators
Principal Investigator: Patrick Y Wuethrich, MD Dep of Anesthesiologiy and Pain treatment, University Hospital Bern, 3010 Bern, Switzerland
  More Information

Publications:

Additional 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
Study First Received: September 11, 2009
Last Updated: June 8, 2010
Health Authority: Switzerland: Ethikkommission

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

ClinicalTrials.gov processed this record on May 23, 2013