Comparing Rectus Sheath Catheter to Epidural Post Cystectomy

NCT02572804 | Unknown

• 2 other identifiers: V15-02041H1502041
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Keywords

bladder cancer-cystectomy; rectus sheath catheter; epidural

Outcome Measures

Primary Outcomes (1)

• Cumulative post-operative opioid consumption

  To Day 3 post-op

Secondary Outcomes (9)

• Visual Analogue Score pain score

  within 4 hours post-operatively and on days 1, 2 and 3 post-operatively

• Patient total intraoperative Opioid requirement

  Intraoperatively

• Total patient fluid requirements throughout hospital admission

  From the start of the operation to day 3 post-operatively.

• Recorded evidence of hypotension

  Until Day 3 postoperatively

• Duration of post-operative ileus

  This will be measured during the patients' inpatient hospital stay - usually up to a maximum of 10 days.

Study Arms (2)

Rectus Sheath Catheter Group

ACTIVE COMPARATOR

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

Device: Rectus Sheath Catheters

Epidural Group

ACTIVE COMPARATOR

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

Device: Epidural

Interventions

Epidural DEVICE

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).

Epidural Group

Rectus Sheath Catheters DEVICE

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).

Rectus Sheath Catheter Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vancouver Coastal Health: lead
• University of British Columbia: collaborator
• Vancouver Prostate Centre: collaborator

Study Sites (1)

Vancouver Prostate Centre, Dept. Urologic Sciences

Vancouver, British Columbia, V6K 2H4, Canada

RECRUITING

Related Publications (7)

• 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.

  PMID: 25496767 BACKGROUND

• 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.

  PMID: 14612482 BACKGROUND

• Rigg JR, Jamrozik K, Myles PS, Silbert BS, Peyton PJ, Parsons RW, Collins KS; MASTER Anaethesia Trial Study Group. Epidural anaesthesia and analgesia and outcome of major surgery: a randomised trial. Lancet. 2002 Apr 13;359(9314):1276-82. doi: 10.1016/S0140-6736(02)08266-1.

  PMID: 11965272 BACKGROUND

• Ready LB. Acute pain: lessons learned from 25,000 patients. Reg Anesth Pain Med. 1999 Nov-Dec;24(6):499-505. doi: 10.1016/s1098-7339(99)90038-x. No abstract available.

  PMID: 10588551 BACKGROUND

• 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.

  PMID: 21242424 BACKGROUND

• 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.

  PMID: 19084856 BACKGROUND

• 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.

  PMID: 23937574 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Pain, Postoperative

Interventions

Injections, Epidural

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Martin E Gleave, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edmund CP Chedgy, MBBS,FRCS

CONTACT

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

Geneveive Lowe, MBBS

CONTACT

604-875-4304

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urologic Surgeon

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: October 9, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: June 1, 2017
• Last Updated: November 2, 2016

Record last verified: 2016-10

Locations

CA (1)