Bladder CancerNCT02572804
Comparing Rectus Sheath Catheter to Epidural Post Cystectomy
A study testing Epidural and Rectus Sheath Catheters in people with Bladder Cancer and Postoperative Pain, run by Vancouver Coastal Health at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Bladder Cancer, Postoperative Pain
- What is being tested?
- Epidural and Rectus Sheath Catheters
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2015to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Geneveive Lowe, MBBS contact
Canada1 site, 1 recruiting
- Recruiting
Vancouver Prostate Centre, Dept. Urologic Sciences
Vancouver, British Columbia, V6K 2H4
Edmund CP Chedgy, MBBS, FRCS, 604-875-4111 ext. 69629, echedgy@prostatecentre.com
Genevieve Lowe, MBBS, 604-875-4304
About this study
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?
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.
Read the 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.
- Conditions
- Bladder Cancer, Postoperative Pain
- Being tested
- Epidural, Rectus Sheath Catheters
- Keywords
- bladder cancer-cystectomy, rectus sheath catheter, epidural
- Medical subject headings
- Urinary Bladder Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpiduralDevice
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 CathetersDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Rectus Sheath Catheter Group | Active comparator | Patients will have rectus sheath catheters surgically inserted with infusion of 0.125% Bupivicaine at 5mls an hour. Receives: 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 Receives: Device: Epidural |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative post-operative opioid consumption
Measured: To Day 3 post-op
Secondary outcomes (9)
Visual Analogue Score pain score
Measured: within 4 hours post-operatively and on days 1, 2 and 3 post-operatively
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.
Measured: Intraoperatively
Total patient fluid requirements throughout hospital admission
Measurement of individual patient fluid balance will be performed up to and including day 3 post-operatively.
Measured: From the start of the operation to 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.
Measured: Until Day 3 postoperatively
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.
Measured: This will be measured during the patients' inpatient hospital stay - usually up to a maximum of 10 days.
Time to mobilisation
Measured: The day at which patient achieves mobilisation - usually at a maximum of 5 days post-operatively
Length of Hospital Stay
Measured: The day at which patient is discharged from hospital- usually on average 10 days post-operatively
Patient Satisfaction with pain control
Patient satisfaction with pain control will be measured using a 9-point Likert scale on day 3 post-operatively.
Measured: 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.
Measured: 30 day morbidity and mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2016 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vancouver Coastal Health
- Sponsor type
- Other government
- Collaborators
- University of British Columbia, Vancouver Prostate Centre
- Responsible party
- Principal investigator, Dr. Alan I. So, Vancouver Coastal Health
- Investigators
- Martin E Gleave, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572804
- Sponsor's protocol ID
- V15-02041
- Other IDs
- H1502041
- Status last verified
- Oct 2016
- First submitted
- 6 Oct 2015
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25496767Block 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.
PubMed 14612482Rigg 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.
PubMed 11965272Ready 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.
PubMed 10588551Gustafsson 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.
PubMed 21242424Guillotreau 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.
PubMed 19084856Dutton 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.
PubMed 23937574
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT02572804
- Acronym / sponsor ID
- V15-02041
- Conditions
- Bladder Cancer, Postoperative Pain
- Keywords
- bladder cancer-cystectomy, rectus sheath catheter, epidural
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Vancouver Coastal HealthOther government
- Collaborators
- University of British Columbia, Vancouver Prostate Centre
- Study start
- Sep 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 9 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rectus Sheath Catheter Group | Active comparator | Device: Rectus Sheath CathetersPatients will have rectus sheath catheters surgically inserted with infusion of 0.125% Bupivicaine at 5mls an hour. |
| Epidural Group | Active comparator | Device: EpiduralPatients will have a standard epidural placement with infusion of 0.125% Bupivicaine at an initial rate of 5mls/hour, titrated to response |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpiduralPatients 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). | Device | Epidural Group |
| Rectus Sheath CathetersPatients 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). | Device | Rectus Sheath Catheter Group |
Primary outcome
Cumulative post-operative opioid consumption
Time frame: To Day 3 post-op
9 secondary outcomes
Visual Analogue Score pain score
Time frame: within 4 hours post-operatively and on days 1, 2 and 3 post-operatively
Patient total intraoperative Opioid requirement
Time frame: Intraoperatively
Total patient fluid requirements throughout hospital admission
Time frame: From the start of the operation to day 3 post-operatively.
Recorded evidence of hypotension
Time frame: Until Day 3 postoperatively
Duration of post-operative ileus
Time frame: This will be measured during the patients' inpatient hospital stay - usually up to a maximum of 10 days.
Time to mobilisation
Time frame: The day at which patient achieves mobilisation - usually at a maximum of 5 days post-operatively
Length of Hospital Stay
Time frame: The day at which patient is discharged from hospital- usually on average 10 days post-operatively
Patient Satisfaction with pain control
Time frame: Day 3 post operatively
Complications and side effects.
Time frame: 30 day morbidity and mortality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Background: PubMed 25496767Bochner 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.
- Background: PubMed 14612482Block 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.
- Background: PubMed 11965272Rigg 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.
- Background: PubMed 10588551Ready 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.
- Background: PubMed 21242424Gustafsson 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.
- Background: PubMed 19084856Guillotreau 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.
- Background: PubMed 23937574Dutton 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.
- European Association of Urology guidelines on reporting post-operative complicationsLink provided by the sponsor.
Related trials for Bladder Cancer
RecruitingPhase 2
Tetra-modality Bladder Preservation Strategies in Muscle-invasive Bladder Cancer: TURBT+ Chemo/Immunotherapy+ Radiation Therapy+ Maintenance Immunotherapy vs. W&W
Muscle-invasive Bladder Cancer
RecruitingObservational study
En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device
Bladder Cancer
Not yet recruiting
Radical CystEctomy or RaDio-chEMotherapy as Preferred Treatment for invasivE blaDder Cancer
Muscle Invasive Bladder Cancer
RecruitingPhase 1/2
A Clinical Study of MK-3120 in People With Bladder Cancer (MK-3120-003)
Bladder Cancer, Urinary Bladder Neoplasms
Active, not recruitingPhase 2
Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)
Metastatic Urothelial Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geneveive Lowe, MBBS contact
Martin E Gleave, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural and Rectus Sheath Catheters in people with Bladder Cancer and Postoperative Pain, run by Vancouver Coastal Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edmund CP Chedgy, MBBS,FRCS (+1 604-875-4111 ext. 69629, echedgy@prostatecentre.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative post-operative opioid consumption (time frame: To Day 3 post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02572804, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.