Effects of Thoracic Epidural Analgesia and Surgery on Lower Urinary Tract Function: A Randomized, Controlled Study

This study has been completed.
Sponsor:
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01220362
First received: October 11, 2010
Last updated: December 14, 2011
Last verified: December 2011
  Purpose

Postoperative urinary retention (POUR) is one of the most common complications after surgery and neuraxial anesthesia of which the treatment of choice is bladder catheterization 1. It has been a common practice to place an indwelling catheter in the bladder in patients receiving epidural analgesia and to leave the catheter as long as the epidural analgesia is maintained despite a lack of evidence supporting this approach.

Transurethral catheterization is associated with significant morbidity such as patient discomfort, urethral trauma and urinary tract infections (UTI). Prolonged catheterization is the primary risk factor for catheter associated UTI (CAUTI), which is one of the most common nosocomial infections and can prolong hospitalisation 2. For this reason there is a growing focus on limiting the duration of catheterization and finding methods to avoid unnecessary catheterization in perioperative medicine 3,4.

Lower urinary tract function depends on coordinated actions between the detrusor muscle and the external urethral sphincter. Motorneurons of both muscles are located in the sacral spinal cord between L1 and S4. Most afferent fibers from the bladder enter the sacral cord through the pelvic nerve at segments L4-S2.

Because epidural analgesia can be performed at various levels of the spinal cord, it is possible to block only a portion of the spinal cord (segmental blockade). Based on the innervation of the bladder and sphincter between L1 and S4 it can be assumed that epidural analgesia within segments T4-6 to T10-12 has no or minimal influence on lower urinary tract function.

In a previous study, we found, against our expectations that thoracic epidural analgesia (TEA) significantly inhibits the detrusor muscle during voiding, resulting in clinically relevant post-void residuals which required monitoring or catheterisation 5. Because the study adopted a before-after design, we could not definitively identify the mechanisms responsible for this change in bladder function. In particular, we could not determine whether TEA per se or surgery was the main cause. Concerning TEA, it remains unclear which compounds of the solution, the local anesthetic, the opioid or both are responsible for the observed changes in lower urinary tract function.

The aim of this study is to compare lower urinary tract function before and during TEA with two different epidural solutions (group 1: bupivacaine 1.25 mg/ml vs group 2: bupivacaine 1.25 mg/ml combined with fentanyl 2 µg/ml) within segments T4-6 to T10-12 for postoperative pain treatment in patients undergoing lumbotomy for open renal surgery.

We expect that a better understanding of lower urinary tract function during TEA could lead to a more restrictive use of indwelling transurethral catheters perioperatively.


Condition Intervention
Analgesia, Epidural
Urodynamics
Urinary Retention
Drug: Bupivacain 0.125%
Drug: Bupivacain 0.125%/Fentanyl 2mcg/ml

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Effects of Thoracic Epidural Analgesia and Surgery on Lower Urinary Tract Function: A Randomized, Controlled Study

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Difference in post-void residual between bupivacaine (group 1) and bupivacaine-fentanyl (group 2) after surgery on day 2 or 3, depending on patient mobilisation. [ Time Frame: day 2 or 3 after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Difference in post-void residual before and after surgery under segmental blockade. [ Time Frame: day 2 or 3 after surgery ] [ Designated as safety issue: Yes ]
  • Difference in secondary outcomes (see 2.1.2.) between group 1 and group 2 before surgery [ Time Frame: day 2 or 3 after surgery ] [ Designated as safety issue: Yes ]
  • Difference in secondary outcomes (see 2.1.2.) before and after surgery under segmental blockade. [ Time Frame: day 2 or 3 after surgery ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: October 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group 1
Bupivacaine 0.125%
Drug: Bupivacain 0.125%
Bupivacain 0.125%
Group 2
Bupivacaine 0.125%/Fentanyl 2mcg/ml
Drug: Bupivacain 0.125%/Fentanyl 2mcg/ml
Bupivacain 0.125%/Fentanyl 2mcg/ml

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent
  • Open kidney surgery with lumbotomy
  • Thoracic epidural analgesia
  • International Prostate Symptom Score (IPSS) < 7
  • Preoperative residual urine volume < 100ml

Exclusion Criteria

  • Contraindications to epidural analgesia or refusal
  • Preoperative residual urine volume > 100ml
  • International Prostate Symptom Score (IPSS) > 7
  • Pregnancy
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01220362

Locations
Switzerland
Dep. of Anesthesiology and Pain Therapy, University Hospital Bern, 3010 Bern,Switzerland
Bern, BE, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Study Chair: Fiona C Burkhard, Prof Dep. of urology, University Hospital Bern, 3010 Bern, Switzerland
  More Information

Publications:
Responsible Party: Dr. med. Patrick Wüthrich, Department of Anesthesiology and Pain Therapy,University Hospital Bern Inselspital Bern
ClinicalTrials.gov Identifier: NCT01220362     History of Changes
Other Study ID Numbers: 093/10
Study First Received: October 11, 2010
Last Updated: December 14, 2011
Health Authority: Switzerland: Independent Local Research Ethic Commission (Ethikkommission)

Keywords provided by University Hospital Inselspital, Berne:
Analgesia, Epidural
Urodynamics
Urinary Retention

Additional relevant MeSH terms:
Urinary Retention
Urination Disorders
Urologic Diseases
Bupivacaine
Fentanyl
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Narcotics
Analgesics
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid

ClinicalTrials.gov processed this record on July 28, 2014