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

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

160

Phase

  • 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 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

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
Intervention / Treatment
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

Outcome Measure
Time Frame
Cumulative post-operative opioid consumption
Time Frame: To Day 3 post-op
To Day 3 post-op

Secondary Outcome Measures

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

Vancouver Coastal Health

Collaborators

University of British Columbia
Vancouver Prostate Centre

Investigators

  • 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

September 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

October 6, 2015

First Submitted That Met QC Criteria

October 8, 2015

First Posted (Estimate)

October 9, 2015

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

October 31, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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