Effects of Thoracic Epidural Administered Ropivacaine Versus Bupivacaine on Bladder Function

NCT02414373 | Completed Phase 4

• 1 other identifier: 390/14
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Urinary Retention

Keywords

urination; analgesia, epidural; local anesthetics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Bladder volume at first desire to void (mL)

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

• Maximum cystometric capacity (mL)

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

• Bladder compliance (mL/cmH2O)

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

• Urethral pressure profile (cmH2O)

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

• Maximum detrusor pressure (cmH2O)

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

Study Arms (2)

Ropivacaine

EXPERIMENTAL

Ropivacaine 2mg/ml (ROPIVACAIN Sintetica 2 mg/ml ™, Sintetica-Bioren, Couvet, Schweiz)

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)

Drug: Bupivacaine; Device: 6 French transurethral dual channel catheter (Gaeltec, Dunvegan, Scotland); Device: 14 French rectal balloon catheter (Gaeltec, Dunvegan, Scotland)

Interventions

Ropivacaine 2mg/ml DRUG

local anesthetics, which will epidurally administered

Ropivacaine

Bupivacaine DRUG

local anesthetics, which will epidurally administered

Bupivacaine

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

Bupivacaine; Ropivacaine

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

Bupivacaine; Ropivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Kidney surgery
• Thoracic epidural analgesia

You may not qualify if:

• Contraindications to epidural analgesia or refusal
• Preoperative postvoid residual urine volume \> 100ml
• International Prostate Symptom Score (IPSS) \> 7

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

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

Bern, Canton of Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Agnosia

Interventions

Ropivacaine; Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Patrick Y Wuethrich, MD

  Department of Anaesthesiology and Pain Therapy, University Hospital Bern Inselspital Bern, 3010 Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2015
• First Posted: April 10, 2015
• Study Start: April 1, 2015
• Primary Completion: May 15, 2017
• Study Completion: May 15, 2017
• Last Updated: May 18, 2017

Record last verified: 2017-05

Locations

CH (1)