Effects of Thoracic Epidural Administered Ropivacaine Versus Bupivacaine on Bladder Function
Primary Purpose
Post Operative Urinary Retention
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Ropivacaine 2mg/ml
Bupivacaine
6 French transurethral dual channel catheter (Gaeltec, Dunvegan, Scotland)
14 French rectal balloon catheter (Gaeltec, Dunvegan, Scotland)
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Urinary Retention focused on measuring urination, analgesia, epidural, local anesthetics
Eligibility Criteria
Inclusion Criteria:
- Written informed consent
- Kidney surgery
- Thoracic epidural analgesia
Exclusion Criteria
- 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)
Sites / Locations
- Patrick Wuethrich, Department of Anaesthesiology and Pain Therapy, University Hospital Bern Inselspital Bern
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ropivacaine
Bupivacaine
Arm Description
Ropivacaine 2mg/ml (ROPIVACAIN Sintetica 2 mg/ml ™, Sintetica-Bioren, Couvet, Schweiz)
Bupivicaine 1.25mg/ml (BUPIVACAIN Sintetica 0.125 % ™ (Bupivacain 1,25 mg/ml), Sintetica-Bioren, Couvet, Schweiz)
Outcomes
Primary Outcome Measures
Post void residual urine volume: Change between postvoid residual urine volume before surgery versus during thoracic epidural analgesia for postoperative analgesia
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT02414373
First Posted
March 26, 2015
Last Updated
May 17, 2017
Sponsor
Insel Gruppe AG, University Hospital Bern
1. Study Identification
Unique Protocol Identification Number
NCT02414373
Brief Title
Effects of Thoracic Epidural Administered Ropivacaine Versus Bupivacaine on Bladder Function
Official Title
Effects of Thoracic Epidural Administered Ropivacaine Versus Bupivacaine on Lower Urinary Tract Function: A Randomized, Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
May 15, 2017 (Actual)
Study Completion Date
May 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Urinary Retention
Keywords
urination, analgesia, epidural, local anesthetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ropivacaine
Arm Type
Experimental
Arm Description
Ropivacaine 2mg/ml (ROPIVACAIN Sintetica 2 mg/ml ™, Sintetica-Bioren, Couvet, Schweiz)
Arm Title
Bupivacaine
Arm Type
Active Comparator
Arm Description
Bupivicaine 1.25mg/ml (BUPIVACAIN Sintetica 0.125 % ™ (Bupivacain 1,25 mg/ml), Sintetica-Bioren, Couvet, Schweiz)
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 2mg/ml
Intervention Description
local anesthetics, which will epidurally administered
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
local anesthetics, which will epidurally administered
Intervention Type
Device
Intervention Name(s)
6 French transurethral dual channel catheter (Gaeltec, Dunvegan, Scotland)
Intervention Type
Device
Intervention Name(s)
14 French rectal balloon catheter (Gaeltec, Dunvegan, Scotland)
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
Bladder volume at first desire to void (mL)
Description
Change of the parameters of the storage and voiding phases from baseline (preoperative) to postoperative day 2 or 3, depending on patient's mobility.
Time Frame
before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days)
Title
Maximum cystometric capacity (mL)
Description
Change of the parameters of the storage and voiding phases from baseline (preoperative) to postoperative day 2 or 3, depending on patient's mobility.
Time Frame
before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days)
Title
Bladder compliance (mL/cmH2O)
Description
Change of the parameters of the storage and voiding phases from baseline (preoperative) to postoperative day 2 or 3, depending on patient's mobility.
Time Frame
before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days)
Title
Urethral pressure profile (cmH2O)
Description
Change of the parameters of the storage and voiding phases from baseline (preoperative) to postoperative day 2 or 3, depending on patient's mobility.
Time Frame
before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days)
Title
Maximum detrusor pressure (cmH2O)
Description
Change of the parameters of the storage and voiding phases from baseline (preoperative) to postoperative day 2 or 3, depending on patient's mobility.
Time Frame
before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days)
Title
Detrusor pressure at maximum flow rate(cmH2O)
Description
Change of the parameters of the storage and voiding phases from baseline (preoperative) to postoperative day 2 or 3, depending on patient's mobility.
Time Frame
before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days)
Title
Maximum flow rate (mL/sec)
Description
Change of the parameters of the storage and voiding phases from baseline (preoperative) to postoperative day 2 or 3, depending on patient's mobility.
Time Frame
before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written informed consent
Kidney surgery
Thoracic epidural analgesia
Exclusion Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Y Wuethrich, MD
Organizational Affiliation
Department of Anaesthesiology and Pain Therapy, University Hospital Bern Inselspital Bern, 3010 Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Patrick Wuethrich, Department of Anaesthesiology and Pain Therapy, University Hospital Bern Inselspital Bern
City
Bern
State/Province
BE
ZIP/Postal Code
3010
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Effects of Thoracic Epidural Administered Ropivacaine Versus Bupivacaine on Bladder Function
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