Comparing Rectus Sheath Catheter to Epidural Post Cystectomy

Not Applicable

• Conditions: Bladder Cancer; Postoperative Pain
• Interventions: Device: Rectus Sheath Catheters; Device: Epidural

• Registration Number: NCT02572804
• Lead Sponsor: Vancouver Coastal Health

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-10-06
• Study First Submitted QC: 2015-10-08
• Study First Posted: 2015-10-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-31
• Last Update Posted: 2016-11-02
• Primary Completion: 2016-12
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rectus Sheath Catheter Group	Rectus Sheath Catheters	Patients will have rectus sheath catheters surgically inserted with infusion of 0.125% Bupivicaine at 5mls an hour.
Epidural Group	Epidural	Patients will have a standard epidural placement with infusion of 0.125% Bupivicaine at an initial rate of 5mls/hour, titrated to response

Primary Outcome Measures

Name	Time	Method
Cumulative post-operative opioid consumption	To Day 3 post-op

Secondary Outcome Measures

Name	Time	Method
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.
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.
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
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.
Visual Analogue Score pain score	within 4 hours post-operatively and on days 1, 2 and 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.
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.
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.

Trial Locations

Locations (1)

Vancouver Prostate Centre, Dept. Urologic Sciences; 🇨🇦 Vancouver, British Columbia, Canada