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Comparing Rectus Sheath Catheter to Epidural Post Cystectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02572804
Recruitment Status : Unknown
Verified October 2016 by Dr. Alan I. So, Vancouver Coastal Health.
Recruitment status was:  Recruiting
First Posted : October 9, 2015
Last Update Posted : November 2, 2016
Sponsor:
Collaborators:
University of British Columbia
Vancouver Prostate Centre
Information provided by (Responsible Party):
Dr. Alan I. So, Vancouver Coastal Health

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Postoperative Pain Device: Epidural Device: Rectus Sheath Catheters Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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?
Study Start Date : September 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

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).




Primary Outcome Measures :
  1. Cumulative post-operative opioid consumption [ Time Frame: To Day 3 post-op ]

Secondary Outcome Measures :
  1. Visual Analogue Score pain score [ Time Frame: within 4 hours post-operatively and on days 1, 2 and 3 post-operatively ]
  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Time to mobilisation [ Time Frame: The day at which patient achieves mobilisation - usually at a maximum of 5 days post-operatively ]
  7. Length of Hospital Stay [ Time Frame: The day at which patient is discharged from hospital- usually on average 10 days post-operatively ]
  8. 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.

  9. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572804


Contacts
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Contact: Edmund CP Chedgy, MBBS,FRCS +1 604-875-4111 ext 69629 echedgy@prostatecentre.com
Contact: Geneveive Lowe, MBBS 604-875-4304

Locations
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Canada, British Columbia
Vancouver Prostate Centre, Dept. Urologic Sciences Recruiting
Vancouver, British Columbia, Canada, V6K 2H4
Contact: Edmund CP Chedgy, MBBS, FRCS    604-875-4111 ext 69629    echedgy@prostatecentre.com   
Contact: Genevieve Lowe, MBBS    604-875-4304      
Sponsors and Collaborators
Vancouver Coastal Health
University of British Columbia
Vancouver Prostate Centre
Investigators
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Principal Investigator: Martin E Gleave, MD University of British Columbia
Additional Information:
Publications:

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Responsible Party: Dr. Alan I. So, Urologic Surgeon, Vancouver Coastal Health
ClinicalTrials.gov Identifier: NCT02572804    
Other Study ID Numbers: V15-02041
H1502041 ( Other Identifier: UBC CREB Number )
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: October 2016
Keywords provided by Dr. Alan I. So, Vancouver Coastal Health:
bladder cancer-cystectomy
rectus sheath catheter
epidural
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases