ThoracotomyNCT00976313
Does Thoracic Epidural Analgesia Influence Urinary Micturition by Patients Undergoing Thoracic Surgery?
An observational study of Thoracotomy and Sternotomy, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracotomy, Sternotomy
- What is being tested?
- Assessment of urinary micturition after thoracotomy and International Prostate Symptom Score
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2009to Apr 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: male and female patients undergoing thoracotomy or sternotomy
Who may be able to join
- Written informed consent
- Thoracic surgery including thoracotomy and sternotomy
- Thoracic epidural analgesia
Who cannot join
- Contraindications to epidural anesthesia or refusal
- Preoperative residual urine volume > 100ml
- International Prostate Symptom Score (IPSS) > 7
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dep of anesthesiology and pain treatment, Bern University Hospital
Bern, 3010
About this study
Official title: Does Thoracic Epidural Analgesia Influence Urinary Micturition by Patients Undergoing Thoracic Surgery? An Observational, Prospective Study
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.
Read the detailed description
Background
- 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.
- Conditions
- Thoracotomy, Sternotomy
- Being tested
- Assessment of urinary micturition after thoracotomy, International Prostate Symptom Score
- Keywords
- thoracic epidural analgesia, urinary micturition, thoracotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of urinary micturition after thoracotomyProcedure or surgery
Post residual urine volume and voided volume will be assessed with Bladder Scan™ BVI 6100 (Bladder scan, Bothell, WA, USA) will be performed the day before surgery and on day 2 after surgery, with epidural analgesia within segments T2-4 to T10 21,22. Bladder sensitivity will be assessed at strong desire to void. On day 2 the bladder will be filled through the transurethral catheter till the patient signalised a strong desire to void, then the catheter will be removed and spontaneous micturition will be attempted. Voided volume and post void residual will be assessed.
International Prostate Symptom ScoreOther
International Prostate Symptom Score (IPSS) for assessment of lower urinary tract symptoms (LUTS) preoperatively
| Study group | Role | What they receive |
|---|---|---|
| 1 | male patients Receives: Procedure: Assessment of urinary micturition after thoracotomy; Other: International Prostate Symptom Score | |
| 2 | female patients Receives: Procedure: Assessment of urinary micturition after thoracotomy; Other: International Prostate Symptom Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in postvoid residual urine volume before and during thoracic epidural analgesia
Measured: 3 days
Secondary outcomes (3)
Voided volume
Measured: 3 days
Maximum bladder capacity
Measured: 3 days
Bladder sensitivity (yes/no) at strong desire to void
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ThoracotomyStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Investigators
- Patrick Y Wuethrich, MD, Principal investigator, Dep of Anesthesiologiy and Pain treatment, University Hospital Bern, 3010 Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00976313
- Sponsor's protocol ID
- 171/09
- Status last verified
- Jun 2010
- First submitted
- 11 Sep 2009
- Last updated
- 9 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 6159487Kau 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.
PubMed 12934418Weiniger 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.
PubMed 16978160Axelsson 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.
PubMed 3993320Basse 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.
PubMed 11009235Wuethrich 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.
PubMed 21455089
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Thoracic Epidural Analgesia Influence Urinary Micturition by Patients Undergoing Thoracic Surgery? An Observational, Prospective Study
- ClinicalTrials.gov ID
- NCT00976313
- Acronym / sponsor ID
- 171/09
- Conditions
- Thoracotomy, Sternotomy
- Keywords
- thoracic epidural analgesia, urinary micturition, thoracotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 14 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Assessment of urinary micturition after thoracotomy, Other: International Prostate Symptom Scoremale patients |
| 2 | – | Procedure: Assessment of urinary micturition after thoracotomy, Other: International Prostate Symptom Scorefemale patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- male and female patients undergoing thoracotomy or sternotomy
Key inclusion criteria (3 listed)
- Written informed consent
- Thoracic surgery including thoracotomy and sternotomy
- Thoracic epidural analgesia
Key exclusion criteria (4 listed)
- Contraindications to epidural anesthesia or refusal
- Preoperative residual urine volume > 100ml
- International Prostate Symptom Score (IPSS) > 7
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of urinary micturition after thoracotomyPost residual urine volume and voided volume will be assessed with Bladder Scan™ BVI 6100 (Bladder scan, Bothell, WA, USA) will be performed the day before surgery and on day 2 after surgery, with epidural analgesia within segments T2-4 to T10 21,22. Bladder sensitivity will be assessed at strong desire to void. On day 2 the bladder will be filled through the transurethral catheter till the patient signalised a strong desire to void, then the catheter will be removed and spontaneous micturition will be attempted. Voided volume and post void residual will be assessed. | Procedure or surgery | 1, 2 |
| International Prostate Symptom ScoreInternational Prostate Symptom Score (IPSS) for assessment of lower urinary tract symptoms (LUTS) preoperatively | Other | 1, 2 |
Primary outcome
Differences in postvoid residual urine volume before and during thoracic epidural analgesia
Time frame: 3 days
3 secondary outcomes
Voided volume
Time frame: 3 days
Maximum bladder capacity
Time frame: 3 days
Bladder sensitivity (yes/no) at strong desire to void
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2010.
- Background: PubMed 6159487Appell 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.
- Background: PubMed 12934418Kau 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.
- Background: PubMed 16978160Weiniger 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.
- Background: PubMed 3993320Axelsson 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.
- Background: PubMed 11009235Basse 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.
- Derived from this study: PubMed 21455089Wuethrich 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Y Wuethrich, MD principal investigator
Dep of Anesthesiologiy and Pain treatment, University Hospital Bern, 3010 Bern, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracotomy and Sternotomy, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in postvoid residual urine volume before and during thoracic epidural analgesia (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00976313, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2010.