Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT02572804
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT02572804
Study Brief:
Protocol Section:
NCT02572804