Does Thoracic Epidural Analgesia Influence Urinary Micturition by Patients Undergoing Thoracic Surgery?
1 other identifier
observational
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2009
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 11, 2009
CompletedFirst Posted
Study publicly available on registry
September 14, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedJune 9, 2010
June 1, 2010
7 months
September 11, 2009
June 8, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Differences in postvoid residual urine volume before and during thoracic epidural analgesia
3 days
Secondary Outcomes (3)
Voided volume
3 days
Maximum bladder capacity
3 days
Bladder sensitivity (yes/no) at strong desire to void
3 days
Study Arms (2)
1
male patients
2
female patients
Interventions
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 Score (IPSS) for assessment of lower urinary tract symptoms (LUTS) preoperatively
Eligibility Criteria
male and female patients undergoing thoracotomy or sternotomy
You may qualify if:
- Written informed consent
- Thoracic surgery including thoracotomy and sternotomy
- Thoracic epidural analgesia
You may not qualify if:
- Contraindications to epidural anesthesia or refusal
- Preoperative residual urine volume \> 100ml
- International Prostate Symptom Score (IPSS) \> 7
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dep of anesthesiology and pain treatment, Bern University Hospital
Bern, 3010, Switzerland
Related Publications (6)
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.
PMID: 6159487BACKGROUNDKau 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.
PMID: 12934418BACKGROUNDWeiniger 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.
PMID: 16978160BACKGROUNDAxelsson 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.
PMID: 3993320BACKGROUNDBasse 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.
PMID: 11009235BACKGROUNDWuethrich 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.
PMID: 21455089DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick Y Wuethrich, MD
Dep of Anesthesiologiy and Pain treatment, University Hospital Bern, 3010 Bern, Switzerland
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 11, 2009
First Posted
September 14, 2009
Study Start
September 1, 2009
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
June 9, 2010
Record last verified: 2010-06