Comparing Rectus Sheath Catheter to Epidural Post Cystectomy
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|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
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer Postoperative Pain||Device: Epidural Device: Rectus Sheath Catheters||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
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).
- Cumulative post-operative opioid consumption [ Time Frame: To Day 3 post-op ]
- Visual Analogue Score pain score [ Time Frame: 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.
- 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.
- 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.
- 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.
- Time to mobilisation [ Time Frame: 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 ]
- 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.
- 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.
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
|Contact: Edmund CP Chedgy, MBBS,FRCS||+1 604-875-4111 ext firstname.lastname@example.org|
|Contact: Geneveive Lowe, MBBS||604-875-4304|
|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 email@example.com|
|Contact: Genevieve Lowe, MBBS 604-875-4304|
|Principal Investigator:||Martin E Gleave, MD||University of British Columbia|