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Post Operative Urinary RetentionPhase 4NCT02414373

Effects of Thoracic Epidural Administered Ropivacaine Versus Bupivacaine on Bladder Function

A Phase 4 study testing Ropivacaine 2mg/ml, Bupivacaine and 6 French transurethral dual channel catheter (Gaeltec, Dunvegan, Scotland) in people with Post Operative Urinary Retention, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Post Operative Urinary Retention
What is being tested?
Ropivacaine 2mg/ml, Bupivacaine and 6 French transurethral dual channel catheter (Gaeltec, Dunvegan, Scotland)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteSwitzerland
Study dates
Apr 2015to 15 May 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent
  • Kidney surgery
  • Thoracic epidural analgesia

Who cannot join

  • Contraindications to epidural analgesia or refusal
  • Preoperative postvoid residual urine volume > 100ml
  • International Prostate Symptom Score (IPSS) > 7
  • Pregnancy (pregnancy test in all women who are not in menopause, exclusion for surgery per se)

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Patrick Wuethrich, Department of Anaesthesiology and Pain Therapy, University Hospital Bern Inselspital Bern

    Bern, Canton of Bern, 3010

Other trials in Switzerland

About this study

Official title: Effects of Thoracic Epidural Administered Ropivacaine Versus Bupivacaine on Lower Urinary Tract Function: A Randomized, Controlled Study

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.

Read the detailed description

Background

Acute urinary retention is one of the most common complications after surgery and anesthesia. It can occur in patients of both sexes and all age groups and after all types of surgical procedures. It is linked to several factors including increased intravenous fluids, postoperative pain and type of anaesthesia.

Micturition depends on coordinated actions between the detrusor muscle and the external urethral sphincter. Motorneurons of both muscles are located in the sacral spinal cord and coordination between them occurs in the pontine tegmentum of the caudal brain stem. Motorneurons innervating the external urethral sphincter are located in the nucleus of Onuf, extending from segment S1 to S3. The detrusor smooth muscle is innervated by parasympathetic fibers, which reside in the sacral intermediolateral cell group and are located in S2-4. Sympathetic fibers innervating the bladder and urethra play an important role in promoting continence and are located in the intermediolateral cell group of the lumbar cord (L1-L4). Most afferent fibers from the bladder enter the sacral cord through the pelvic nerve at segments L4-S2 and the majority are thin myelinated or unmyelinated.

There are few studies on the urodynamic effects of various anaesthetic agents, which mainly focused on lumbar epidural anaesthesia. 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). Based on knowledge of the bladder innervations, it can be assumed that epidural analgesia within segments T4-6 to T10-12 has no or minimal influences on lower urinary tract function.

In a previous study, the investigators found, against their expectations, that thoracic epidural analgesia (TEA) with bupivacaine significantly inhibits the detrusor muscle during voiding, resulting in clinically relevant post void residuals which required monitoring or transurethral catheterisation 11. This detrusor inhibition is comparable to a motor blockade.

In addition, it is known that the epidural administration of ropivacaine during labour results in a clinically relevant reduction of motor blocks. However, the analgesic potency of ropivacaine is approximately 60% that of bupivacaine.

Objective

The main objectives of this investigator initiated trial are:

  • To analyse if a TEA with the local anesthetics ropivacaine leads to less detrusor atony and thus resulting to lower incidence of postvoid residual urine volume resulting in postoperative urinary retention.
  • To compare urodynamic parameters (storage and voiding phases) during TEA with ropivacaine versus bupivacaine.

Methods

Assessments of bladder function:

International Prostate Symptom Score (IPSS) will be used for assessment of lower urinary tract symptoms preoperatively.

Urodynamic investigations will be performed: The first investigation will be done as baseline data before attempted surgery.

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. All methods, definitions and units will be in accordance with the standards recommended by the International Continence Society.

Being tested
Ropivacaine 2mg/ml, Bupivacaine, 6 French transurethral dual channel catheter (Gaeltec, Dunvegan, Scotland), 14 French rectal balloon catheter (Gaeltec, Dunvegan, Scotland)
Keywords
urination, analgesia, epidural, local anesthetics
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ropivacaine 2mg/mlDrug

    local anesthetics, which will epidurally administered

  • BupivacaineDrug

    local anesthetics, which will epidurally administered

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

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

Study groups in NCT02414373
Study groupRoleWhat they receive
RopivacaineExperimentalRopivacaine 2mg/ml (ROPIVACAIN Sintetica 2 mg/ml ™, Sintetica-Bioren, Couvet, Schweiz)
Receives: Drug: Ropivacaine 2mg/ml; Device: 6 French transurethral dual channel catheter (Gaeltec, Dunvegan, Scotland); Device: 14 French rectal balloon catheter (Gaeltec, Dunvegan, Scotland)
BupivacaineActive comparatorBupivicaine 1.25mg/ml (BUPIVACAIN Sintetica 0.125 % ™ (Bupivacain 1,25 mg/ml), Sintetica-Bioren, Couvet, Schweiz)
Receives: Drug: Bupivacaine; Device: 6 French transurethral dual channel catheter (Gaeltec, Dunvegan, Scotland); Device: 14 French rectal balloon catheter (Gaeltec, Dunvegan, Scotland)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Post void residual urine volume: Change between postvoid residual urine volume before surgery versus during thoracic epidural analgesia for postoperative analgesia

    Measured: before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days)

Secondary outcomes (7)
  1. Bladder volume at first desire to void (mL)

    Change of the parameters of the storage and voiding phases from baseline (preoperative) to postoperative day 2 or 3, depending on patient's mobility.

    Measured: before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days)

  2. Maximum cystometric capacity (mL)

    Change of the parameters of the storage and voiding phases from baseline (preoperative) to postoperative day 2 or 3, depending on patient's mobility.

    Measured: before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days)

  3. Bladder compliance (mL/cmH2O)

    Change of the parameters of the storage and voiding phases from baseline (preoperative) to postoperative day 2 or 3, depending on patient's mobility.

    Measured: before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days)

  4. Urethral pressure profile (cmH2O)

    Change of the parameters of the storage and voiding phases from baseline (preoperative) to postoperative day 2 or 3, depending on patient's mobility.

    Measured: before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days)

  5. Maximum detrusor pressure (cmH2O)

    Change of the parameters of the storage and voiding phases from baseline (preoperative) to postoperative day 2 or 3, depending on patient's mobility.

    Measured: before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days)

  6. Detrusor pressure at maximum flow rate(cmH2O)

    Change of the parameters of the storage and voiding phases from baseline (preoperative) to postoperative day 2 or 3, depending on patient's mobility.

    Measured: before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days)

  7. Maximum flow rate (mL/sec)

    Change of the parameters of the storage and voiding phases from baseline (preoperative) to postoperative day 2 or 3, depending on patient's mobility.

    Measured: before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2015 (estimated)
  2. Study startApr 2015
  3. Primary completion15 May 2017
  4. Study completion15 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02414373
Sponsor's protocol ID
390/14
Status last verified
May 2017
First submitted
26 Mar 2015
Last updated
18 May 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ropivacaine 2mg/ml, Bupivacaine and 6 French transurethral dual channel catheter (Gaeltec, Dunvegan, Scotland) in people with Post Operative Urinary Retention, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post void residual urine volume: Change between postvoid residual urine volume before surgery versus during thoracic epidural analgesia for postoperative analgesia (time frame: before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2017.

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