Comparing Rectus Sheath Catheter to Epidural Post Cystectomy

Vancouver Coastal Health

Status: Unknown

Conditions: Postoperative Pain; Bladder Cancer

Treatments: Device: Rectus Sheath Catheters; Device: Epidural

Study type: Interventional

Funder types: Other

Identifiers

NCT02572804

V15-02041

H1502041 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Rectus Sheath Catheter Group

Active Comparator group

Description:

Patients will have rectus sheath catheters surgically inserted with infusion of 0.125% Bupivicaine at 5mls an hour.

Treatment:

Device: Rectus Sheath Catheters

Epidural Group

Active Comparator group

Description:

Patients will have a standard epidural placement with infusion of 0.125% Bupivicaine at an initial rate of 5mls/hour, titrated to response

Treatment:

Device: Epidural