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UrodynamicsNCT00790231

Effects of Thoracic Epidural Anesthesia on Lower Urinary Tract Function

An observational study of Urodynamics and Acute Urinary Retention, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Acute urinary retention is one of the most common complications after surgery and anesthesia. Overfilling the bladder can stretch and damage the detrusor muscle, leading to atony of the bladder. It can occur in patients of both sexes and all age groups and after all types of surgical procedures. Read more about this study

Who is it for?
Any age
Conditions the study is for
Urodynamics, Acute Urinary Retention
What is being tested?
urodynamic procedure
Type of treatment
Medical device
How many people
32 participants
Where
1 siteSwitzerland
Study dates
Oct 2008to Oct 2009
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: open kidney surgery with lumbotomy, thoracic epidural analgesia

Who may be able to join

  • Written informed consent
  • Open kidney surgery with lumbotomy
  • Thoracic epidural analgesia

Who cannot join

  • Significant renal dysfunction (creatinin >200mol/l)
  • Contraindications to epidural anesthesia or refusal
  • Preoperative residual urine volume > 100ml
  • International Prostate Symptom Score (IPSS) > 7
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Department of Urology, Bern University Hospital

    Bern, 3010

Other trials in Switzerland

About this study

Acute urinary retention is one of the most common complications after surgery and anesthesia. Overfilling the bladder can stretch and damage the detrusor muscle, leading to atony of the bladder. It can occur in patients of both sexes and all age groups and after all types of surgical procedures. 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 then 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 smooth detrusor muscle is inner-vated 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 conti-nence 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. Because peridural anesthesia can be performed at various levels of the spinal cord and with varying concentrations of local anesthetic, it is possible to block only a portion of the spinal cord (segmental blockade). So it seems logical that peridural analgesia from a Th 2-4 to Th 10-12 will have no influence on the micturition reflex. Studies on the urodynamic effects of various anaesthetic agents are rare. Under the influence of epidural analgesia, patients may not feel the urge to urinate, which may result in urinary retention and bladder over distension. Spinal and epidural opioid administrations influence the function of the lower urinary tract by direct spinal action on the sacral nociceptive neurons and autonomic fibres. It is therefore a common practice for bladder catheterisation in the presence of spinal or epidural anesthesia. The excessive use of a transurethral catheter is undoubtedly associated with significant morbidity such patient discomfort, urinary tract infections, catheter entrapment, bladder calculi formation, urethral trauma and stricture. The risk of infection with a single catheterization is 1-2% and can rise to 3 to 7 % a day. There has yet been no consensus for appropriate catheterisation strategy and urodynamic changes under thoracic epidural anesthesia are still unknown. We expect that a better knowledge on the bladder function under epidural analgesia could lead to a more restrictive use of perioperative transurethral catheters. Our hypothesis is that thoracic epidural analgesia does not influence lower urinary tract function in the male and female. Therefore transurethral catheterization is not mandatory for all patients with thoracic epidural analgesia. Differences in post void residual urine volume and urodynamic examinations before and during thoracic epidural analgesia will be analyzed in 16 men and 16 women undergoing open kidney surgery/lumbotomy who receive thoracic epidural anesthesia perioperatively.

Read the detailed description

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 anesthesia. 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. nlike 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, 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. 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. Long acting local anesthetics administrated intrathecally rapidly block the micturition reflex. Detrusor contraction is restored approximately 7-8 hours after spinal injection of bupivacaine. 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. Traumatic or prolonged catheterization may lead to urethritis and to urethral strictures. There has yet been no consensus for appropriate catheterisation strategy during regional anesthesia. We expect that a better knowledge on the bladder function under epidural analgesia could lead to a more restrictive use of perioperative transurethral catheters.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 Th4-6 to Th 10-12 for postoperative pain treatment in patients undergoing lumbotomy for kidney surgery.

Being tested
urodynamic procedure
Keywords
urinary bladder, thoracic epidural analgesia, urodynamics, open kidney surgery with lumbotomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • urodynamic procedureDevice

    introduction of the urodynamic catheter into the bladder and assessment of the bladder function

Study groups in NCT00790231
Study groupRoleWhat they receive
menobservation of the urinary function with and without thoracic epidural anesthesia
Receives: Device: urodynamic procedure
womenobservation of the urinary function with and without thoracic epidural anesthesia
Receives: Device: urodynamic procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Differences in postvoid residual urine volume before and during thoracic epidural analgesia

    Measured: first measure preoperative, second measure on day 2 or 3 after surgeryx

Secondary outcomes (3)
  1. Bladder volume at first desire to void

    Measured: first measure preoperative, second measure on day 2 or 3 after surgery

  2. Bladder compliance

    Measured: first measure preoperative, second measure on day 2 or 3 after surgery

  3. Maximum detrusor pressure

    Measured: first measure preoperative, second measure on day 2 or 3 after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionOct 2009
  4. Study completionOct 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00790231
Sponsor's protocol ID
KEK_105_08
Status last verified
Nov 2009
First submitted
11 Nov 2008
Last updated
20 Nov 2009
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Urodynamics and Acute Urinary Retention, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differences in postvoid residual urine volume before and during thoracic epidural analgesia (time frame: first measure preoperative, second measure on day 2 or 3 after surgeryx). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2009.

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