Comparing Rectus Sheath Catheter to Epidural Post Cystectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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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?

Conditions
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Postoperative Pain, Bladder Cancer

Intervention / Treatment
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* Device: Epidural
* Device: Rectus Sheath Catheters


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rectus Sheath Catheter Group<br>Patients will have rectus sheath catheters surgically inserted with infusion of 0.125% Bupivicaine at 5mls an hour. | Device: Rectus Sheath Catheters<br>* 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).<br>|
| Active Comparator: Epidural Group<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Score pain score |  | 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. | 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. | 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. | 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. | This will be measured during the patients' inpatient hospital stay - usually up to a maximum of 10 days. | 
| Time to mobilisation |  | The day at which patient achieves mobilisation - usually at a maximum of 5 days 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 | 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. | At 30 days an electronic note review will be performed to evaluate for 30 day mortality and morbidity. | 30 day morbidity and mortality | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bladder cancer-cystectomy, rectus sheath catheter, epidural