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

NCT01220362 | Completed

• 1 other identifier: 093/10
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Analgesia, Epidural; Urodynamics; Urinary Retention

Keywords

Analgesia, Epidural; Urodynamics; Urinary Retention

Outcome Measures

Primary Outcomes (1)

• 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.

  day 2 or 3 after surgery

Secondary Outcomes (3)

• Difference in post-void residual before and after surgery under segmental blockade.

  day 2 or 3 after surgery

• Difference in secondary outcomes (see 2.1.2.) between group 1 and group 2 before surgery

  day 2 or 3 after surgery

• Difference in secondary outcomes (see 2.1.2.) before and after surgery under segmental blockade.

  day 2 or 3 after surgery

Study Arms (2)

Group 1

OTHER

Bupivacaine 0.125%

Drug: Bupivacain 0.125%

Group 2

OTHER

Bupivacaine 0.125%/Fentanyl 2mcg/ml

Drug: Bupivacain 0.125%/Fentanyl 2mcg/ml

Interventions

Bupivacain 0.125% DRUG

Bupivacain 0.125%

Group 1

Bupivacain 0.125%/Fentanyl 2mcg/ml DRUG

Bupivacain 0.125%/Fentanyl 2mcg/ml

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Contraindications to epidural analgesia or refusal
• Preoperative residual urine volume \> 100ml
• International Prostate Symptom Score (IPSS) \> 7
• Pregnancy

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Dep. of Anesthesiology and Pain Therapy, University Hospital Bern, 3010 Bern,Switzerland

Bern, Canton of Bern, 3010, Switzerland

Location

Related Publications (2)

• Baldini G, Bagry H, Aprikian A, Carli F. Postoperative urinary retention: anesthetic and perioperative considerations. Anesthesiology. 2009 May;110(5):1139-57. doi: 10.1097/ALN.0b013e31819f7aea.

  PMID: 19352147 BACKGROUND

• Wuethrich PY, Kessler TM, Panicker JN, Curatolo M, Burkhard FC. Detrusor activity is impaired during thoracic epidural analgesia after open renal surgery. Anesthesiology. 2010 Jun;112(6):1345-9. doi: 10.1097/ALN.0b013e3181d4f4fe.

  PMID: 20461004 RESULT

MeSH Terms

Conditions

Agnosia; Urinary Retention

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Fiona C Burkhard, Prof

  Dep. of urology, University Hospital Bern, 3010 Bern, Switzerland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 11, 2010
• First Posted: October 13, 2010
• Study Start: October 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: December 15, 2011

Record last verified: 2011-12

Locations

CH (1)