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Effects of Thoracic Epidural Administered Ropivacaine Versus Bupivacaine on Bladder Function

NCT02414373 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2017-05-18

No results posted yet for this study

Summary

Acute urinary retention is one of the most common complications after surgery and anesthesia. Micturition depends on coordinated actions between the detrusor muscle and the external urethral sphincter. Under the influence of epidural analgesia, patients may not feel the sensation of bladder filling, which can result in urinary retention and bladder overdistension. Overfilling of the bladder can stretch and in some cases permanently damage the detrusor muscle. Because epidural anesthesia can be performed at various levels of the spinal cord, it is possible to block only a portion of the spinal cord (segmental blockade). Thoracic epidural analgesia with bupivacaine significantly inhibits the detrusor muscle during voiding, resulting in clinically relevant post void residuals which required monitoring or transurethral catheterisation. This bladder muscle inhibition is comparable to a motor blockade. The epidural administration of ropivacaine during labour results in a clinically relevant reduction of motor blocks.

The hypothesis is that thoracic epidural analgesia with the local anesthetics ropivacaine leads to less significant changes in bladder function than bupivacaine as a control group, in patients undergoing lumbotomy incision for renal surgery.

Conditions

  • Post Operative Urinary Retention

Interventions

DRUG

Ropivacaine 2mg/ml

local anesthetics, which will epidurally administered

DRUG

Bupivacaine

local anesthetics, which will epidurally administered

DEVICE

6 French transurethral dual channel catheter (Gaeltec, Dunvegan, Scotland)

DEVICE

14 French rectal balloon catheter (Gaeltec, Dunvegan, Scotland)

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Patrick Y Wuethrich, MD · Department of Anaesthesiology and Pain Therapy, University Hospital Bern Inselspital Bern, 3010 Bern

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2017-05-15
Completion
2017-05-15

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02414373 on ClinicalTrials.gov