Clinical trial NCT00976313: Does Thoracic Epidural Analgesia Influence Urinary Micturition by Patients Undergoing Thoracic Surgery?
Official title: Does Thoracic Epidural Analgesia Influence Urinary Micturition by Patients Undergoing Thoracic Surgery? An Observational, Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracotomy
Sternotomy
Keywords: thoracic epidural analgesia
urinary micturition
thoracotomy
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2009-09-14
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: male and female patients undergoing thoracotomy or sternotomy

Brief summary: Under the influence of epidural analgesia, patients may not feel the urge to urinate, which can result in urinary retention and bladder overdistension.

The use of a transurethral catheter is associated with significant morbidity such as patient discomfort, urinary tract infections, urethral trauma and stricture.

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 T2 to T10 for postoperative pain treatment in patients undergoing thoracotomy or sternotomy.

Detailed description: Background

1. 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 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.

Unlike 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 2-8, 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 7. 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 9.

Long acting local anesthetics administrated intrathecally rapidly block the micturition reflex. Detrusor contraction is restored approximately 7-8 hours after spinal injection of bupivacaine 10. 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 11. Traumatic or prolonged catheterization may lead to urethritis and to urethral strictures 12. There has yet been no consensus for appropriate catheterisation strategy 13-15 during regional anesthesia.

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 T2 to T10 for postoperative pain treatment in patients undergoing thoracotomy or sternotomy. We expect that a better knowledge on the bladder function under epidural analgesia could lead to a more restrictive use of perioperative transurethral catheters.

Objective

The aim of this study is to compare lower urinary tract function before and during thoracic epidural analgesia within segments T2 to T10 for postoperative pain treatment in patients undergoing thoracotomy or sternotomy. We expect that a better knowledge on the bladder function under epidural analgesia could lead to a more restrictive use of perioperative transurethral catheters.

Hypothesis Thoracic epidural analgesia does not influence urinary micturition in the male and female. Therefore transurethral catheterisation is not mandatory for all patients with thoracic epidural analgesia undergoing thoracic surgery.

Methods

Prospective, open, observational, follow up study. Setting: Department of thoracic surgery, University Hospital Bern

Study population A total of 26 patients (13 men and 13 women per group) undergoing thoracic surgery who receive thoracic epidural anesthesia perioperatively will be needed.

Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Thoracic surgery including thoracotomy and sternotomy
* Thoracic epidural analgesia

Exclusion Criteria

* Contraindications to epidural anesthesia or refusal
* Preoperative residual urine volume \> 100ml
* International Prostate Symptom Score (IPSS) \> 7
* Pregnancy

Primary outcomes:
measure: Differences in postvoid residual urine volume before and during thoracic epidural analgesia
timeFrame: 3 days
Secondary outcomes:
measure: Voided volume
timeFrame: 3 days
measure: Maximum bladder capacity
timeFrame: 3 days
measure: Bladder sensitivity (yes/no) at strong desire to void
timeFrame: 3 days
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Dep of anesthesiology and pain treatment, Bern University Hospital
Study officials:
affiliation: Dep of Anesthesiologiy and Pain treatment, University Hospital Bern, 3010 Bern, Switzerland
name: Patrick Y Wuethrich, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Appell RA, England HR, Hussell AR, McGuire EJ. The effects of epidural anesthesia on the urethral closure pressure profile in patients with prostatic enlargement. J Urol. 1980 Sep;124(3):410-1. doi: 10.1016/s0022-5347(17)55474-9.
citation: Kau YC, Lee YH, Li JY, Chen C, Wong SY, Wong TK. Epidural anesthesia does not increase the incidences of urinary retention and hesitancy in micturition after ambulatory hemorrhoidectomy. Acta Anaesthesiol Sin. 2003 Jun;41(2):61-4.
citation: Weiniger CF, Wand S, Nadjari M, Elchalal U, Mankuta D, Ginosar Y, Matot I. Post-void residual volume in labor: a prospective study comparing parturients with and without epidural analgesia. Acta Anaesthesiol Scand. 2006 Nov;50(10):1297-303. doi: 10.1111/j.1399-6576.2006.01122.x. Epub 2006 Sep 15.
citation: Axelsson K, Mollefors K, Olsson JO, Lingardh G, Widman B. Bladder function in spinal anaesthesia. Acta Anaesthesiol Scand. 1985 Apr;29(3):315-21. doi: 10.1111/j.1399-6576.1985.tb02207.x.
citation: Basse L, Werner M, Kehlet H. Is urinary drainage necessary during continuous epidural analgesia after colonic resection? Reg Anesth Pain Med. 2000 Sep-Oct;25(5):498-501. doi: 10.1053/rapm.2000.9537.
citation: Wuethrich PY, Henning A, Schweizerhof M, Kessler TM, Burkhard FC. Postvoid residuals remain unchanged in patients with postoperative thoracic epidural analgesia after thoracotomy. Reg Anesth Pain Med. 2011 Jan-Feb;36(1):46-50. doi: 10.1097/AAP.0b013e3182030828.