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

• Register: ISRCTN
• Last refreshed on: 5 June 2017
• Main ID: ISRCTN17075012
• Date of registration: 02/04/2015
• Prospective Registration: Yes
• Primary sponsor: Department of Anaesthesiology, University Hospital Inselspital
• Public title: Effects of thoracic epidural administered drugs on lower urinary tract function: a randomized controlled study
• Scientific title: Effects of thoracic epidural administered ropivacaine versus bupivacaine on lower urinary tract function: a randomized controlled study
• Date of first enrolment: 17/04/2015
• Target sample size: 42
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN17075012
• Study type: Interventional
• Study design: Randomized parallel-group single-centre interventional assessor-blind trial (Treatment)
• Phase: Phase IV

Countries of recruitment

Switzerland

Contacts

• Name: Patrick Wuethrich

Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Kidney surgery
Surgery

Intervention(s)

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/ml (ROPIVACAIN Sintetica 2 mg/ml ™, Sintetica-Bioren, Couvet, Schweiz)
Group 2: Bupivicaine 1.25 mg/ml (BUPIVACAIN Sintetica 0.125 % ™ (Bupivacain 1.25 mg/ml – Fentanyl 2 µg/ml), Sintetica-Bioren, Couvet, Schweiz)

Primary Outcome(s)

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 Outcome(s)

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.

Secondary ID(s)

SNCTP000001322

Source(s) of Monetary Support

University Hospital Inselspital