Ignite Creation Date:
2024-05-05 @ 10:59 PM
Last Modification Date:
2024-10-26 @ 10:26 AM
Study NCT ID:
NCT01220362
Status:
COMPLETED
Last Update Posted:
2011-12-15
First Post:
2010-10-11
Brief Title:
Effects of Thoracic Epidural Analgesia and Surgery on Lower Urinary Tract Function A Randomized Controlled Study
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
Effects of Thoracic Epidural Analgesia and Surgery on Lower Urinary Tract Function A Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2011-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 34
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 125 mgml vs group 2 bupivacaine 125 mgml combined with fentanyl 2 µgml 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
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 34
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 125 mgml vs group 2 bupivacaine 125 mgml combined with fentanyl 2 µgml 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
Detailed Description:
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 530
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
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 530
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None