Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| H1502041 | Other Identifier | UBC CREB Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of British Columbia | OTHER |
| Vancouver Prostate Centre | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rectus Sheath Catheter Group | Active Comparator | Patients will have rectus sheath catheters surgically inserted with infusion of 0.125% Bupivicaine at 5mls an hour. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative post-operative opioid consumption | To Day 3 post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Score pain score | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Edmund CP Chedgy, MBBS,FRCS | Contact | +1 604-875-4111 | 69629 | echedgy@prostatecentre.com |
| Geneveive Lowe, MBBS | Contact | 604-875-4304 |
| Name | Affiliation | Role |
|---|---|---|
| Martin E Gleave, MD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver Prostate Centre, Dept. Urologic Sciences | Recruiting | Vancouver | British Columbia | V6K 2H4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25496767 | Background | 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. | |
| 14612482 |
| Label | URL |
|---|---|
| European Association of Urology guidelines on reporting post-operative complications | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D007268 | Injections, Epidural |
| ID | Term |
|---|---|
| D007278 | Injections, Spinal |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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). |
|
| 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. | 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. | 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. | This will be measured during the patients' inpatient hospital stay - usually up to a maximum of 10 days. |
| Time to mobilisation | The day at which patient achieves mobilisation - usually at a maximum of 5 days post-operatively |
| Length of Hospital Stay | 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. | 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. | 30 day morbidity and mortality |
| 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. |
| 11965272 | 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. |
| 10588551 | 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. |
| 21242424 | 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. |
| 19084856 | 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. |
| 23937574 | 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. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013812 |
| Therapeutics |