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.
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
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.
- Conditions
- Post Operative Urinary Retention
- 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 group | Role | What they receive |
|---|---|---|
| Ropivacaine | Experimental | Ropivacaine 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) |
| Bupivacaine | Active comparator | Bupivicaine 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.
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)
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)
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)
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)
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)
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)
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)
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.
- First posted10 Apr 2015 (estimated)
- Study startApr 2015
- Primary completion15 May 2017
- Study completion15 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Urinary RetentionStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Y Wuethrich, MD, Principal investigator, Department of Anaesthesiology and Pain Therapy, University Hospital Bern Inselspital Bern, 3010 Bern
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
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Thoracic Epidural Administered Ropivacaine Versus Bupivacaine on Lower Urinary Tract Function: A Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT02414373
- Acronym / sponsor ID
- 390/14
- Conditions
- Post Operative Urinary Retention
- Keywords
- urination, analgesia, epidural, local anesthetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- 15 May 2017 (actual)
- Study completion
- 15 May 2017 (actual)
- First posted
- 10 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine | Experimental | Drug: Ropivacaine 2mg/ml, Device: 6 French transurethral dual channel catheter (Gaeltec, Dunvegan, Scotland), Device: 14 French rectal balloon catheter (Gaeltec, Dunvegan, Scotland)Ropivacaine 2mg/ml (ROPIVACAIN Sintetica 2 mg/ml ™, Sintetica-Bioren, Couvet, Schweiz) |
| Bupivacaine | Active comparator | Drug: Bupivacaine, Device: 6 French transurethral dual channel catheter (Gaeltec, Dunvegan, Scotland), Device: 14 French rectal balloon catheter (Gaeltec, Dunvegan, Scotland)Bupivicaine 1.25mg/ml (BUPIVACAIN Sintetica 0.125 % ™ (Bupivacain 1,25 mg/ml), Sintetica-Bioren, Couvet, Schweiz) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent
- Kidney surgery
- Thoracic epidural analgesia
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine 2mg/mllocal anesthetics, which will epidurally administered | Drug | Ropivacaine |
| Bupivacainelocal anesthetics, which will epidurally administered | Drug | Bupivacaine |
| 6 French transurethral dual channel catheter (Gaeltec, Dunvegan, Scotland) | Device | Bupivacaine, Ropivacaine |
| 14 French rectal balloon catheter (Gaeltec, Dunvegan, Scotland) | Device | Bupivacaine, Ropivacaine |
Primary outcome
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)
7 secondary outcomes
Bladder volume at first desire to void (mL)
Time frame: before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days)
Maximum cystometric capacity (mL)
Time frame: before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days)
Bladder compliance (mL/cmH2O)
Time frame: before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days)
Urethral pressure profile (cmH2O)
Time frame: before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days)
Maximum detrusor pressure (cmH2O)
Time frame: before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days)
Detrusor pressure at maximum flow rate(cmH2O)
Time frame: before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days)
Maximum flow rate (mL/sec)
Time frame: before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Y Wuethrich, MD principal investigator
Department of Anaesthesiology and Pain Therapy, University Hospital Bern Inselspital Bern, 3010 Bern
1 site in 1 country: see every site and its status.
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.