Comparing Rectus Sheath Catheter to Epidural Post Cystectomy (NCT02572804) | Clinical Trial Compass
UnknownNot Applicable
Comparing Rectus Sheath Catheter to Epidural Post Cystectomy
Canada160 participantsStarted 2015-09
Plain-language 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.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.