NCT00790231

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

November 20, 2009

Status Verified

November 1, 2009

Enrollment Period

1 year

First QC Date

November 11, 2008

Last Update Submit

November 19, 2009

Conditions

Keywords

urinary bladderthoracic epidural analgesiaurodynamicsopen kidney surgery with lumbotomy

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (3)

  • Bladder volume at first desire to void

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

  • Bladder compliance

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

  • Maximum detrusor pressure

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

Study Arms (2)

men

observation of the urinary function with and without thoracic epidural anesthesia

Device: urodynamic procedure

women

observation of the urinary function with and without thoracic epidural anesthesia

Device: urodynamic procedure

Interventions

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

menwomen

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

open kidney surgery with lumbotomy, thoracic epidural analgesia

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology, Bern University Hospital

Bern, 3010, Switzerland

Location

Study Officials

  • Fiona C Burkhard, Prod

    Dep. of Urology, Bern University Hospital

    STUDY CHAIR
  • Patrick Y Wüthrich, MD

    Dep. of Anesthsiology, Bern University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 11, 2008

First Posted

November 13, 2008

Study Start

October 1, 2008

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

November 20, 2009

Record last verified: 2009-11

Locations