Bladder Cancer, Postoperative Pain
Conditions
Keywords
bladder cancer-cystectomy, rectus sheath catheter, epidural
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.
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.
Interventions
DEVICEEpidural
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).
DEVICERectus 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).
Sponsors
University of British Columbia
Vancouver Prostate Centre
Vancouver Coastal Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative post-operative opioid consumption | To Day 3 post-op |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient total intraoperative Opioid requirement | 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 | 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 | 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 | 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. |
| Visual Analogue Score pain score | within 4 hours post-operatively and on days 1, 2 and 3 post-operatively | — |
| Length of Hospital Stay | The day at which patient is discharged from hospital- usually on average 10 days post-operatively | — |
| Patient Satisfaction with pain control | 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. | 30 day morbidity and mortality | At 30 days an electronic note review will be performed to evaluate for 30 day mortality and morbidity. |
| Time to mobilisation | The day at which patient achieves mobilisation - usually at a maximum of 5 days post-operatively | — |
Countries
Canada
Contacts
Primary ContactEdmund CP Chedgy, MBBS,FRCS
Backup ContactGeneveive Lowe, MBBS
Outcome results
None listed