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Comparing Rectus Sheath Catheter to Epidural Post Cystectomy

Primary Purpose

Bladder Cancer, Postoperative Pain

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Epidural

Rectus Sheath Catheters

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring bladder cancer-cystectomy, rectus sheath catheter, epidural

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Vancouver Prostate Centre, Dept. Urologic SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Rectus Sheath Catheter Group

Epidural Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Cumulative post-operative opioid consumption

Secondary Outcome Measures

Visual Analogue Score pain score

Patient total intraoperative Opioid requirement

Opioid requirement will be measured in morphine equivalents and reported as such on a per patient basis and measured throughout the operation.

Total patient fluid requirements throughout hospital admission

Measurement of individual patient fluid balance will be performed up to and including day 3 post-operatively.

Recorded evidence of hypotension

Hypotension for the purposes of this study is defined as a systolic blood pressure of less than 95.

Duration of post-operative ileus

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

Length of Hospital Stay

Patient Satisfaction with pain control

Patient satisfaction with pain control will be measured using a 9-point Likert scale on day 3 post-operatively.

Complications and side effects.

At 30 days an electronic note review will be performed to evaluate for 30 day mortality and morbidity.

Full Information

NCT ID

NCT02572804

First Posted

October 6, 2015

Last Updated

October 31, 2016

Sponsor

Vancouver Coastal Health

Collaborators

University of British Columbia, Vancouver Prostate Centre

1. Study Identification

Unique Protocol Identification Number

NCT02572804

Brief Title

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

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Unknown status

Study Start Date

September 2015 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vancouver Coastal Health

Collaborators

University of British Columbia, Vancouver Prostate Centre

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bladder Cancer, Postoperative Pain

Keywords

bladder cancer-cystectomy, rectus sheath catheter, epidural

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Rectus Sheath Catheter Group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Epidural Group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Epidural

Intervention Description

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).

Intervention Type

Device

Intervention Name(s)

Rectus Sheath Catheters

Intervention Description

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 Information:

Title

Cumulative post-operative opioid consumption

Time Frame

To Day 3 post-op

Secondary Outcome Measure Information:

Title

Visual Analogue Score pain score

Time Frame

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

Title

Patient total intraoperative Opioid requirement

Description

Opioid requirement will be measured in morphine equivalents and reported as such on a per patient basis and measured throughout the operation.

Time Frame

Intraoperatively

Title

Total patient fluid requirements throughout hospital admission

Description

Measurement of individual patient fluid balance will be performed up to and including day 3 post-operatively.

Time Frame

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

Title

Recorded evidence of hypotension

Description

Hypotension for the purposes of this study is defined as a systolic blood pressure of less than 95.

Time Frame

Until Day 3 postoperatively

Title

Duration of post-operative ileus

Description

Time Frame

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

Title

Time to mobilisation

Time Frame

The day at which patient achieves mobilisation - usually at a maximum of 5 days post-operatively

Title

Length of Hospital Stay

Time Frame

The day at which patient is discharged from hospital- usually on average 10 days post-operatively

Title

Patient Satisfaction with pain control

Description

Patient satisfaction with pain control will be measured using a 9-point Likert scale on day 3 post-operatively.

Time Frame

Day 3 post operatively

Title

Complications and side effects.

Description

At 30 days an electronic note review will be performed to evaluate for 30 day mortality and morbidity.

Time Frame

30 day morbidity and mortality

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Edmund CP Chedgy, MBBS,FRCS

Phone

+1 604-875-4111

Ext

69629

echedgy@prostatecentre.com

First Name & Middle Initial & Last Name or Official Title & Degree

Geneveive Lowe, MBBS

Phone

604-875-4304

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin E Gleave, MD

Organizational Affiliation

University of British Columbia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vancouver Prostate Centre, Dept. Urologic Sciences

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6K 2H4

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Edmund CP Chedgy, MBBS, FRCS

Phone

604-875-4111

Ext

69629

echedgy@prostatecentre.com

First Name & Middle Initial & Last Name & Degree

Genevieve Lowe, MBBS

Phone

604-875-4304

12. IPD Sharing Statement

Citations:

PubMed Identifier

25496767

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.

Results Reference

background

PubMed Identifier

14612482

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.

Results Reference

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PubMed Identifier

11965272

Citation

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.

Results Reference

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PubMed Identifier

10588551

Citation

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.

Results Reference

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PubMed Identifier

21242424

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.

Results Reference

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PubMed Identifier

19084856

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.

Results Reference

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PubMed Identifier

23937574

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.

Results Reference

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Comparing Rectus Sheath Catheter to Epidural Post Cystectomy

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