Clinical trial NCT02572804: Comparing Rectus Sheath Catheter to Epidural Post Cystectomy
Official title: A Randomised Controlled Trial of Thoracic Epidural Analgesia Versus Surgically Placed Rectus Sheath Catheters for Open Radical Cystectomy: Is There a Difference in Patient Outcomes?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bladder Cancer
Postoperative Pain
Keywords: bladder cancer-cystectomy
rectus sheath catheter
epidural
Lead sponsor: Vancouver Coastal Health
Sponsor class: OTHER_GOV
Collaborators: name: University of British Columbia
name: Vancouver Prostate Centre
First posted: 2015-10-09
Enrollment: 160
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Cumulative post-operative opioid consumption
timeFrame: To Day 3 post-op
Secondary outcomes:
measure: Visual Analogue Score pain score
timeFrame: within 4 hours post-operatively and on days 1, 2 and 3 post-operatively
measure: Patient total intraoperative Opioid requirement
timeFrame: Intraoperatively
measure: Total patient fluid requirements throughout hospital admission
timeFrame: From the start of the operation to day 3 post-operatively.
measure: Recorded evidence of hypotension
timeFrame: Until Day 3 postoperatively
measure: Duration of post-operative ileus
timeFrame: This will be measured during the patients' inpatient hospital stay - usually up to a maximum of 10 days.
measure: Time to mobilisation
timeFrame: The day at which patient achieves mobilisation - usually at a maximum of 5 days post-operatively
measure: Length of Hospital Stay
timeFrame: The day at which patient is discharged from hospital- usually on average 10 days post-operatively
measure: Patient Satisfaction with pain control
timeFrame: Day 3 post operatively
measure: Complications and side effects.
timeFrame: 30 day morbidity and mortality
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver Prostate Centre, Dept. Urologic Sciences
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Martin E Gleave, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bochner BH, Dalbagni G, Sjoberg DD, Silberstein J, Keren Paz GE, Donat SM, Coleman JA, Mathew S, Vickers A, Schnorr GC, Feuerstein MA, Rapkin B, Parra RO, Herr HW, Laudone VP. Comparing Open Radical Cystectomy and Robot-assisted Laparoscopic Radical Cystectomy: A Randomized Clinical Trial. Eur Urol. 2015 Jun;67(6):1042-1050. doi: 10.1016/j.eururo.2014.11.043. Epub 2014 Dec 8.
citation: Block BM, Liu SS, Rowlingson AJ, Cowan AR, Cowan JA Jr, Wu CL. Efficacy of postoperative epidural analgesia: a meta-analysis. JAMA. 2003 Nov 12;290(18):2455-63. doi: 10.1001/jama.290.18.2455.
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citation: Gustafsson UO, Hausel J, Thorell A, Ljungqvist O, Soop M, Nygren J; Enhanced Recovery After Surgery Study Group. Adherence to the enhanced recovery after surgery protocol and outcomes after colorectal cancer surgery. Arch Surg. 2011 May;146(5):571-7. doi: 10.1001/archsurg.2010.309. Epub 2011 Jan 17.
citation: Guillotreau J, Game X, Mouzin M, Doumerc N, Mallet R, Sallusto F, Malavaud B, Rischmann P. Radical cystectomy for bladder cancer: morbidity of laparoscopic versus open surgery. J Urol. 2009 Feb;181(2):554-9; discussion 559. doi: 10.1016/j.juro.2008.10.011. Epub 2008 Dec 13.
citation: Dutton TJ, McGrath JS, Daugherty MO. Use of rectus sheath catheters for pain relief in patients undergoing major pelvic urological surgery. BJU Int. 2014 Feb;113(2):246-53. doi: 10.1111/bju.12316. Epub 2013 Aug 13.