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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
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).
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).
Vancouver Prostate Centre, Dept. Urologic Sciences
Vancouver, British Columbia, Canada
RECRUITINGCumulative 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
Opioid requirement will be measured in morphine equivalents and reported as such on a per patient basis and measured throughout the operation.
Time frame: Intraoperatively
Total patient fluid requirements throughout hospital admission
Measurement of individual patient fluid balance will be performed up to and including day 3 post-operatively.
Time frame: From the start of the operation to day 3 post-operatively.
Recorded evidence of hypotension
Hypotension for the purposes of this study is defined as a systolic blood pressure of less than 95.
Time frame: Until Day 3 postoperatively
Duration of post-operative ileus
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 frame: 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
Length of Hospital Stay
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Time frame: The day at which patient is discharged from hospital- usually on average 10 days post-operatively
Patient Satisfaction with pain control
Patient satisfaction with pain control will be measured using a 9-point Likert scale on day 3 post-operatively.
Time frame: Day 3 post operatively
Complications and side effects.
At 30 days an electronic note review will be performed to evaluate for 30 day mortality and morbidity.
Time frame: 30 day morbidity and mortality