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

This study has been completed.
Sponsor:
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

September 11, 2009
June 8, 2010
September 2009
April 2010   (final data collection date for primary outcome measure)
Differences in postvoid residual urine volume before and during thoracic epidural analgesia [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00976313 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Does Thoracic Epidural Analgesia Influence Urinary Micturition by Patients Undergoing Thoracic Surgery?
Does Thoracic Epidural Analgesia Influence Urinary Micturition by Patients Undergoing Thoracic Surgery? An Observational, Prospective Study

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.

Background

1. Background Acute urinary retention is one of the most common complications after surgery and anesthesia. It can occur in patients of both sexes and all age groups and after all types of surgical procedures. It is linked to several factors including increased intravenous fluids, postoperative pain and type of anaesthesia 1.

Micturition depends on coordinated actions between the detrusor muscle and the external urethral sphincter. Motorneurons of both muscles are located in the sacral spinal cord and coordination between them occurs in the pontine tegmentum of the caudal brain stem. Motorneurons innervating the external urethral sphincter are located in the nucleus of Onuf, extending from the S1 to the S3 segment. The detrusor smooth muscle is innervated by parasympathetic fibers, which reside in the sacral intermediolateral cell group and are located in S2-4. Sympathetic fibers innervating the bladder and urethra play an important role in promoting continence and are located in the intermediolateral cell group of the lumbar cord (L1-L4). Most afferent fibers from the bladder enter the sacral cord through the pelvic nerve at segments L4-S2 and the majority are thin myelinated or unmyelinated.

Unlike spinal anesthesia, which is an all or none block, epidural anesthesia has applications ranging from analgesia with minimal motor block to dense anesthesia (differential blockade). Because epidural anesthesia can be performed at various levels of the spinal cord, it is possible to block only a portion of the spinal cord (segmental blockade). Therefore it can be assumed that epidural analgesia within segments Th 4-6 to Th 10-12 has no or minimal influence on the micturition reflex.

There are few studies on the urodynamic effects of various anaesthetic agents 2-8, focused on lumbar epidural anaesthesia. Under the influence of epidural analgesia, patients may not feel the urge to urinate, which can result in urinary retention and bladder overdistension. Overfilling of the bladder can stretch and damage the detrusor muscle.

For example, the use of lumbar epidural analgesia for labor and delivery has frequently been implicated as a causative factor for postpartum urinary retention. This is supported by the fact that these patients demonstrate a difficulty voiding 7. Spinal and epidural opioid administration influence the function of the lower urinary tract by direct spinal action on the sacral nociceptive neurons and autonomic fibres 9.

Long acting local anesthetics administrated intrathecally rapidly block the micturition reflex. Detrusor contraction is restored approximately 7-8 hours after spinal injection of bupivacaine 10. For this reason, bladder catheterisation is a common practice in patients with spinal or epidural anesthesia.

The use of a transurethral catheter is associated with significant morbidity such as patient discomfort, urinary tract infections, urethral trauma and stricture. The risk of infection with a single catheterization is 1-2% and can rise by 3 to 7 % for every additional day with a indwelling catheter 11. Traumatic or prolonged catheterization may lead to urethritis and to urethral strictures 12. There has yet been no consensus for appropriate catheterisation strategy 13-15 during regional anesthesia.

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. We expect that a better knowledge on the bladder function under epidural analgesia could lead to a more restrictive use of perioperative transurethral catheters.

Objective

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. We expect that a better knowledge on the bladder function under epidural analgesia could lead to a more restrictive use of perioperative transurethral catheters.

Hypothesis Thoracic epidural analgesia does not influence urinary micturition in the male and female. Therefore transurethral catheterisation is not mandatory for all patients with thoracic epidural analgesia undergoing thoracic surgery.

Methods

Prospective, open, observational, follow up study. Setting: Department of thoracic surgery, University Hospital Bern

Study population A total of 26 patients (13 men and 13 women per group) undergoing thoracic surgery who receive thoracic epidural anesthesia perioperatively will be needed.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

male and female patients undergoing thoracotomy or sternotomy

  • Thoracotomy
  • Sternotomy
  • 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
  • 1
    male patients
    Interventions:
    • Procedure: Assessment of urinary micturition after thoracotomy
    • Other: International Prostate Symptom Score
  • 2
    female patients
    Interventions:
    • Procedure: Assessment of urinary micturition after thoracotomy
    • Other: International Prostate Symptom Score

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
April 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00976313
171/09
No
Dr. Patrick Y. Wuethrich, Universitätsklink für Anästhesiologie und Schmerztherapie, Inselspital, Bern, Switzerland
University Hospital Inselspital, Berne
Not Provided
Principal Investigator: Patrick Y Wuethrich, MD Dep of Anesthesiologiy and Pain treatment, University Hospital Bern, 3010 Bern, Switzerland
University Hospital Inselspital, Berne
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP