Effects of Thoracic Epidural Administered Ropivacaine Versus Bupivacaine on Bladder Function

Post Operative Urinary Retention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02414373
• Other study ID #: 390/14
• Status: Completed
• Phase: Phase 4
• First received: March 26, 2015
• Last updated: May 17, 2017
• Start date: April 2015
• Est. completion date: May 15, 2017

Study information

• Verified date: May 2017
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 15, 2017
• Est. primary completion date: May 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Post Operative Urinary Retention
• Urinary Retention

Intervention

Drug:
• Ropivacaine 2mg/ml
local anesthetics, which will epidurally administered
• Bupivacaine
local anesthetics, which will epidurally administered

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

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

Locations

Country	Name	City	State
Switzerland	Patrick Wuethrich, Department of Anaesthesiology and Pain Therapy, University Hospital Bern Inselspital Bern	Bern	BE

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post void residual urine volume: Change between postvoid residual urine volume before surgery versus during thoracic epidural analgesia for postoperative analgesia		before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days)
Secondary	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.	before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days)
Secondary	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.	before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days)
Secondary	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.	before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days)
Secondary	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.	before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days)
Secondary	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.	before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days)
Secondary	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.	before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days)
Secondary	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.	before surgery/TEA (baseline), during TEA (expected to be on average ca. 5 days)