Effects of Thoracic Epidural Anesthesia on Lower Urinary Tract Function

NCT ID: NCT00790231

Last Updated: 2009-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Urodynamics Acute Urinary Retention

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

urinary bladder thoracic epidural analgesia urodynamics open kidney surgery with lumbotomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

men

observation of the urinary function with and without thoracic epidural anesthesia

urodynamic procedure

Intervention Type DEVICE

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

women

observation of the urinary function with and without thoracic epidural anesthesia

urodynamic procedure

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

urodynamic procedure

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Universitätsklinik für Anästhesiologie und Shcmerztherapie

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Fiona C Burkhard, Prod

Role: STUDY_CHAIR

Dep. of Urology, Bern University Hospital

Patrick Y Wüthrich, MD

Role: PRINCIPAL_INVESTIGATOR

Dep. of Anesthsiology, Bern University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Urology, Bern University Hospital

Bern, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KEK_105_08

Identifier Type: -

Identifier Source: org_study_id