NCT00976313

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

June 9, 2010

Status Verified

June 1, 2010

Enrollment Period

7 months

First QC Date

September 11, 2009

Last Update Submit

June 8, 2010

Conditions

Keywords

thoracic epidural analgesiaurinary micturitionthoracotomy

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

Procedure: Assessment of urinary micturition after thoracotomyOther: International Prostate Symptom Score

2

female patients

Procedure: Assessment of urinary micturition after thoracotomyOther: International Prostate Symptom Score

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.

12

International Prostate Symptom Score (IPSS) for assessment of lower urinary tract symptoms (LUTS) preoperatively

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

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: 6159487BACKGROUND
  • 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.

    PMID: 12934418BACKGROUND
  • 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.

    PMID: 16978160BACKGROUND
  • 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.

    PMID: 3993320BACKGROUND
  • 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.

    PMID: 11009235BACKGROUND
  • 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.

Study Officials

  • Patrick Y Wuethrich, MD

    Dep of Anesthesiologiy and Pain treatment, University Hospital Bern, 3010 Bern, Switzerland

    PRINCIPAL INVESTIGATOR

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

Locations