Comparing Rectus Sheath Catheter to Epidural Post Cystectomy

October 31, 2016 updated by: Dr. Alan I. So, Vancouver Coastal Health

A Randomised Controlled Trial of Thoracic Epidural Analgesia Versus Surgically Placed Rectus Sheath Catheters for Open Radical Cystectomy: Is There a Difference in Patient Outcomes?

This is a prospective randomised controlled trial that will compare the outcomes of rectus sheath catheters to epidurals in patients who have undergone a cystectomy, via a lower midline abdominal incision for bladder cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will compare the outcomes of two different pain control techniques, used as standard of care, following major abdominal surgery for bladder removal. Rectus sheath catheters are small tubes that are positioned into a specific area of the cut abdominal wall at the end of surgery; whereas an epidural is a tube that is positioned into the back. Both allow administration of local anaesthetic for pain control. The current gold standard is an epidural. This study will aim to evaluate this and show the comparative efficacy of the rectus sheath catheter, which anecdotally the investigators have found superior in practice.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Geneveive Lowe, MBBS
  • Phone Number: 604-875-4304

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6K 2H4
        • Recruiting
        • Vancouver Prostate Centre, Dept. Urologic Sciences
        • Contact:
        • Contact:
          • Genevieve Lowe, MBBS
          • Phone Number: 604-875-4304

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients over or equal to the age of 19 years old who can understand the study protocol and are able to give consent
  • Patients with an American Society of Anaesthesiology (ASA) classification 1 to 3
  • Patients must have a preoperative oral 24 hour opioid consumption of less than or equal to 30mg morphine equivalents
  • Patients must be able to understand and be able to use patient controlled analgesia
  • Patients must be undergoing a cystectomy with an infra-umbilical midline incision

Exclusion Criteria:

  • Patients with BMI greater than 40
  • Patients with an allergy to local anaesthetics
  • Patients who are contraindicated to having an epidural (e.g. coagulopathic, distorted anatomy, patient refusal, infection at the site of proposed insertion)
  • Patients with previous spinal surgery at the proposed site of epidural
  • Patients with neurodegenerative disorders or spinal cord injury
  • Patients with known anatomy that would not permit placement of the rectus sheath catheters e.g. Prune Belly Syndrome
  • Patients undergoing another complex abdominal procedure in addition to cystectomy and reconstruction requiring extension of the abdominal incision above the umbilicus.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Rectus Sheath Catheter Group
Patients will have rectus sheath catheters surgically inserted with infusion of 0.125% Bupivicaine at 5mls an hour.
Device: Rectus Sheath Catheters
Patients in this group will have surgically inserted rectus sheath catheters (bilaterally), immediately prior to closure of the anterior abdominal wall. These will be infused with 0.125% Bupivicaine at 5mls an hour at a standard rate.Patients will also receive a patient controlled analgesia with hydromorphone 0.2mg/ml, bolus of 200 micrograms with 6 minute lock out (variable in accordance with anesthetic preference).
Active Comparator: Epidural Group
Patients will have a standard epidural placement with infusion of 0.125% Bupivicaine at an initial rate of 5mls/hour, titrated to response
Device: Epidural
Patients in this group will have an epidural inserted in a standard fashion, prior to the induction of anesthesia. These will be infused with 0.125% Bupivicaine at an initial rate of 5mls/hour, titrated to response. Patients will also receive a patient controlled analgesia with hydromorphone 0.2mg/ml, bolus of 200 micrograms with 6 minute lock out (variable in accordance with anesthetic preference).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Cumulative post-operative opioid consumption
Time Frame: To Day 3 post-op
To Day 3 post-op

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visual Analogue Score pain score
Time Frame: within 4 hours post-operatively and on days 1, 2 and 3 post-operatively
within 4 hours post-operatively and on days 1, 2 and 3 post-operatively
Patient total intraoperative Opioid requirement
Time Frame: Intraoperatively
Opioid requirement will be measured in morphine equivalents and reported as such on a per patient basis and measured throughout the operation.
Intraoperatively
Total patient fluid requirements throughout hospital admission
Time Frame: From the start of the operation to day 3 post-operatively.
Measurement of individual patient fluid balance will be performed up to and including day 3 post-operatively.
From the start of the operation to day 3 post-operatively.
Recorded evidence of hypotension
Time Frame: Until Day 3 postoperatively
Hypotension for the purposes of this study is defined as a systolic blood pressure of less than 95.
Until Day 3 postoperatively
Duration of post-operative ileus
Time Frame: This will be measured during the patients' inpatient hospital stay - usually up to a maximum of 10 days.
Ileus will be measured by a 3 separate variables - bowel sounds, passing of flatus and opening of bowels. The post-operative day on which each of these targets is achieved for each patient will be recorded.
This will be measured during the patients' inpatient hospital stay - usually up to a maximum of 10 days.
Time to mobilisation
Time Frame: The day at which patient achieves mobilisation - usually at a maximum of 5 days post-operatively
The day at which patient achieves mobilisation - usually at a maximum of 5 days post-operatively
Length of Hospital Stay
Time Frame: The day at which patient is discharged from hospital- usually on average 10 days post-operatively
The day at which patient is discharged from hospital- usually on average 10 days post-operatively
Patient Satisfaction with pain control
Time Frame: Day 3 post operatively
Patient satisfaction with pain control will be measured using a 9-point Likert scale on day 3 post-operatively.
Day 3 post operatively
Complications and side effects.
Time Frame: 30 day morbidity and mortality
At 30 days an electronic note review will be performed to evaluate for 30 day mortality and morbidity.
30 day morbidity and mortality

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vancouver Coastal Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of British Columbia
Vancouver Prostate Centre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Martin E Gleave, MD, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 6, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 9, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • V15-02041
  • H1502041 (Other Identifier: UBC CREB Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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