Urinary Retention Clinical Trial
Official title:
Effects of Thoracic Epidural Analgesia and Surgery on Lower Urinary Tract Function: A Randomized, Controlled Study
Postoperative urinary retention (POUR) is one of the most common complications after surgery
and neuraxial anesthesia of which the treatment of choice is bladder catheterization 1. It
has been a common practice to place an indwelling catheter in the bladder in patients
receiving epidural analgesia and to leave the catheter as long as the epidural analgesia is
maintained despite a lack of evidence supporting this approach.
Transurethral catheterization is associated with significant morbidity such as patient
discomfort, urethral trauma and urinary tract infections (UTI). Prolonged catheterization is
the primary risk factor for catheter associated UTI (CAUTI), which is one of the most common
nosocomial infections and can prolong hospitalisation 2. For this reason there is a growing
focus on limiting the duration of catheterization and finding methods to avoid unnecessary
catheterization in perioperative medicine 3,4.
Lower urinary tract function depends on coordinated actions between the detrusor muscle and
the external urethral sphincter. Motorneurons of both muscles are located in the sacral
spinal cord between L1 and S4. Most afferent fibers from the bladder enter the sacral cord
through the pelvic nerve at segments L4-S2.
Because epidural analgesia can be performed at various levels of the spinal cord, it is
possible to block only a portion of the spinal cord (segmental blockade). Based on the
innervation of the bladder and sphincter between L1 and S4 it can be assumed that epidural
analgesia within segments T4-6 to T10-12 has no or minimal influence on lower urinary tract
function.
In a previous study, we found, against our expectations that thoracic epidural analgesia
(TEA) significantly inhibits the detrusor muscle during voiding, resulting in clinically
relevant post-void residuals which required monitoring or catheterisation 5. Because the
study adopted a before-after design, we could not definitively identify the mechanisms
responsible for this change in bladder function. In particular, we could not determine
whether TEA per se or surgery was the main cause. Concerning TEA, it remains unclear which
compounds of the solution, the local anesthetic, the opioid or both are responsible for the
observed changes in lower urinary tract function.
The aim of this study is to compare lower urinary tract function before and during TEA with
two different epidural solutions (group 1: bupivacaine 1.25 mg/ml vs group 2: bupivacaine
1.25 mg/ml combined with fentanyl 2 µg/ml) within segments T4-6 to T10-12 for postoperative
pain treatment in patients undergoing lumbotomy for open renal surgery.
We expect that a better understanding of lower urinary tract function during TEA could lead
to a more restrictive use of indwelling transurethral catheters perioperatively.
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 segment S1 to S3. 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.
There are few studies on the urodynamic effects of various anaesthetic agents 2-8, which
mainly focused on lumbar epidural anaesthesia. Under the influence of epidural analgesia,
patients may not feel the sensation of bladder filling, which can result in urinary
retention and bladder overdistension. Overfilling of the bladder can stretch and in some
cases permanently damage the detrusor muscle.
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). Based on knowledge
of the bladder innervations, it can be assumed that epidural analgesia within segments T4-6
to T10-12 has no or minimal influences on lower urinary tract function.
In a previous study, we found, against our expectations that thoracic epidural analgesia
significantly inhibits the detrusor muscle during voiding, resulting in clinically relevant
post void residuals which required monitoring or transurethral catheterisation 9. Because
the study adopted a before-after design, we could not definitively identify the mechanisms
responsible for bladder dysfunction. In particular, we could not say whether thoracic
epidural analgesia per se or surgery was the cause of bladder dysfunction. Furthermore, it
remains which ingredients, whether the local anesthetic, the opioid or both are behind
changes in voiding function.
Objective
In our previous studies, we found that TEA significantly inhibits the detrusor muscle during
voiding, resulting in clinically relevant post-void residuals which required monitoring or
catheterization with similar findings 5,30.
Because these studies adopted a before-after design, we could not definitively identify the
mechanisms responsible for lower urinary tract dysfunction. In particular, we could not say
whether TEA per se or surgery was the cause of lower urinary tract dysfunction. Furthermore,
it remains unclear which compounds in the epidural solution, the local anesthetic, the
opioid or both are behind the observed changes in lower urinary tract function.
The objectives of this study are to determine if TEA per se or surgery are the cause of
bladder dysfunction and which drugs in the epidural solution are responsible for this
effect.
Methods
Randomised controlled double-blind study. Patients will be randomly allocated to one of the
two groups by a computer-generated randomization list. Randomization will be stratified by
gender, in order to reach an equal number of male and females in the two groups. Patients
and investigators will be blinded to the epidural solution administrated.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
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