Recruiting

Rectus Sheath Catheter vs. EpiduralComparing Rectus Sheath Catheter to Epidural Post Cystectomy

Sponsor:

Vancouver Coastal Health

Code:

NCT02572804

Conditions

Bladder Cancer

Postoperative Pain

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Epidural

Rectus Sheath Catheters

Study Details

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.

Conditions

Bladder Cancer

Postoperative Pain

Study ID

NCT02572804

Start date

Sep, 2015

Status verified date

Oct, 2016

Completion date

Jun, 2017

Anticipated

Primary completion date

Dec, 2016

Anticipated

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Rectus Sheath Catheter Group

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

active comparator: Epidural Group

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

Interventions

Epidural

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).

Rectus Sheath Catheters

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).

Primary outcome measure

Cumulative post-operative opioid consumption [ Time Frame: To Day 3 post-op ]

Central Contacts and Locations

Central contacts

Edmund CP Chedgy, MBBS,FRCS

+1 604-875-4111 echedgy@prostatecentre.com

Geneveive Lowe, MBBS

604-875-4304

Locations

Vancouver Prostate Centre, Dept. Urologic Sciences

Recruiting

Vancouver, British Columbia, Canada, V6K 2H4

Contacts

Edmund CP Chedgy, MBBS, FRCS

604-875-4111 echedgy@prostatecentre.com

Genevieve Lowe, MBBS

604-875-4304

More Information

Sponsor

Vancouver Coastal Health

Last update posted

Nov 2, 2016

Last verified

Oct, 2016

Keywords

bladder cancer-cystectomy
rectus sheath catheter
epidural

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vancouver Coastal Health on 2016-11-02.