Skip to content

Effects of thoracic epidural administered drugs on lower urinary tract function: a randomized controlled study

Effects of thoracic epidural administered ropivacaine versus bupivacaine on lower urinary tract function: a randomized controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17075012
Enrollment
42
Registered
2015-04-02
Start date
2015-04-17
Completion date
Unknown
Last updated
2017-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney surgery Surgery

Interventions

All patients will receive a TEA placed at the insertion site interspace T7-8 or T8-9. Segmental blockade will be achieved using the solutions according to the randomisation. Group 1: Ropivacaine 2 mg/

Sponsors

Department of Anaesthesiology, University Hospital Inselspital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Written informed consent 2. Kidney surgery 3. Thoracic epidural analgesia

Exclusion criteria

Exclusion criteria: 1. Contraindications to epidural analgesia or refusal 2. Preoperative PVR > 100 ml 3. International Prostate Symptom Score (IPSS) > 7 4. Pregnancy (pregnancy test in all women who are not in menopause, exclusion for surgery per se)

Design outcomes

Primary

MeasureTime frame
Post-void residual urine volume (in ml) during thoracic epidural analgesia, measured before surgery (baseline) and on postoperative two or three depending of the patient’s mobility.

Secondary

MeasureTime frame
Urodynamic parameters of the storage phase and micturition (e.g. bladder volume at first desire to void, maximum cystometric capacity, bladder compliance, urethral pressure profile, detrusor activity, maximum detrusor pressure, detrusor pressure at maximum flow rate, maximum flow rate, pelvic floor electromyographic activity, incidence of urinary retention). Primary and secondary outcomes will be measured before surgery (baseline) and on postoperative two or three depending of the patient’s mobility. The method used will an urodynamic investigation and secondly assessment of the parameters of the voiding phase. Urodynamic investigations will be performed according to good urodynamic practice. After placement of a 6 French transurethral dual channel catheter and a 14 French rectal balloon catheter (Gaeltec, Dunvegan, Scotland), the bladder will be filled at a rate of 25 to 50 ml/min with Ringer’s lactate solution at room temperature. Parameters of both the storage phase (maximum cystometric capacity, bladder compliance) and voiding phase (detrusor pressure at maximum flow rate [PdetQmax], maximum flow rate [Qmax] and PVR) will be recorded. A TRITON™ multichannel urodynamic system will be used for all measurements (Laborie Medical Technologies Corp., Toronto, Canada). All methods, definitions and units will be in accordance with the standards recommended by the International Continence Society.

Countries

Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026