An interventional study of Rectus sheath block and Bilateral rectus sheath catheter in Bladder Neoplasm, Prostate Neoplasm and Pelvic Neoplasm, sponsored by University of Alberta. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-28.
Sponsored by University of Alberta · Not applicable, Interventional, and Treatment
Among 154 studies in Urinary Bladder Neoplasms with a site in Canada — 33 open to participants now, 60 under way, 21 of them phase 3. Urinary Bladder Neoplasms · Canada.
Among the 154 studies in Urinary Bladder Neoplasms with a site in Canada, this one is the 103rd largest by enrollment of the 136 interventional ones that give a count, is one of 12 that started in 2018, is one of 13 with no phase, and was the 70th registered.
1,800 studies on the registry are indexed under Urinary Bladder Neoplasms; 446 are open to participants now.
Browse Urinary Bladder Neoplasms studies →33 of the 154 studies in Urinary Bladder Neoplasms with a site in Canada are open now. Recruiting first, the newest first:
AstraZeneca · Sites in Canada, United States, Australia and 13 more countries
Ages 18+
Novartis Pharmaceuticals · Sites in Canada, United States, Australia and 1 more country
Ages 18+
Astellas Pharma Global Development, Inc. · Sites in Canada, United States, Korea, Republic of and 1 more country
Ages 18+
Merck Sharp & Dohme LLC · Sites in Canada, United States, Argentina and 14 more countries
Ages 18+
Photocure · Sites in Canada, United States, Belgium and 2 more countries
Ages 18+
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 336 Urinary Bladder Neoplasms studies recruiting now, 256 (76%) set no upper age limit and 22 (7%) stop at 75 or younger; 22 take children under 18; 21 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
154 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 37 · Phase 2 66 · Phase 3 46
First in 1996; this study’s year is marked. 12 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 49 is below the median of 60 across 1,296 interventional studies indexed under Urinary Bladder Neoplasms.
Median enrollment 155 across the 136 interventional studies, 209 across the 16 observational. Of the 84 that completed or were terminated, 34 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
92 of 154 have an industry lead sponsor. The 10 most frequent:
University of Alberta is the lead sponsor of 824 studies on the registry; 170 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
University of Alberta has 2 studies filed under Urinary Bladder Neoplasms — fewer than ten, so there is no comparison to draw.
18 of the studies in Urinary Bladder Neoplasms with a site in Canada that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06111235Phase 3CG Oncology, Inc.A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT | 2026-11 |
| NCT04658862Phase 3Janssen Research & Development, LLCA Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder | 2026-12-30 |
| NCT05911295Phase 3Seagen, a wholly owned subsidiary of PfizerDisitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2 | 2027-01-29 |
| NCT02869217University Health Network, TorontoStudy of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors | 2026-11 |
| NCT04963153National Cancer Institute (NCI)Testing Combination Erdafitinib and Enfortumab Vedotin in Metastatic Bladder Cancer After Treatment With Chemotherapy and Immunotherapy | 2026-12-01 |
Add all 18 to your calendar (.ics) → With an account.
Among the 154 studies in Urinary Bladder Neoplasms with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Objectives The primary objective is to demonstrate that in patients undergoing major urologic surgery, Patient Controlled Analgesia (PCA) opioid consumption in the first 24 hours after surgery will be significantly less in patients who have had a single shot rectus sheath block pre-operatively in addition to a post-operative rectus sheath continuous block via surgically placed catheter versus those who only have post-operative rectus sheath continuous block. Secondary outcomes will be opioid requirement intra-operatively, Numerical Rating Scale (NRS) pain scores including maximum pain score in Post Anesthesia Care Unit (PACU) and score at 24 and 48 hours, incidence and severity of nausea, number of vomiting episodes, sedation score, time to first bowel movement, time to first mobilization and duration of hospital stay.
Purpose: To improve analgesia and reduce opioid consumption in patients undergoing major urologic surgery.
Hypothesis: Patients receiving pre-operative single shot rectus sheath blockade in addition to continuous rectus sheath catheters will use less PCA opioid in the first 24 hours post-operatively compared to patients receiving continuous rectus sheath blockade for major urologic surgery.
Justification:
The sensorimotor innervation of the anterior abdominal wall is supplied by the ventral rami of the thoracolumbar spinal (T7-L1) segmental nerves. The thoracolumbar nerves course along the anterolateral wall within the transversus abdominis plane (TAP), and continue anteromedially, before entering the lateral aspect of the posterior rectus sheath. The nerves provide both muscular and cutaneous branches to innervate the muscle fibers and overlying skin with innervation from both left and right nerves supplying the midline. Regional anesthesia techniques for the anterior abdominal wall include both TAP and rectus sheath blocks.
The TAP block has been investigated extensively and shown to reduce opioid analgesia requirements post-operatively. The main difference between TAP block and rectus sheath block is that the rectus sheath block targets the nerves at a more anterior location. Bilateral rectus sheath nerve blocks are required to provide cover for midline incision and the investigators have previously described rectus sheath block with nerve catheter insertion under ultrasound guidance for midline laparotomy. A recent retrospective review from Dutton et al on the use of rectus sheath catheters for major urologic surgery reported that they offer an effective and safe method of peri-operative analgesia in patients undergoing major open urological pelvic surgery. Tudor et al demonstrated that rectus sheath catheters provide analgesia equivalent to that provided by epidurals following laparotomy for colorectal surgery.
At the University of Alberta Hospital, patients having major urologic surgery e.g. cystectomy have surgically placed rectus sheath catheters sited at the end of the procedure as a standard of analgesia care. This is combined with patient-controlled analgesia (PCA) opioid as part of a multimodal approach to post-operative pain control.
One disadvantage of surgically placed TAP and rectus sheath catheters is that they are inserted at the end of surgery. Therefore, the patient does not benefit from them intra-operatively and other methods of analgesia including opiates are required to reduce the sympathetic response to surgical stimulation and to prevent excessive immediate and early post-operative pain. The surgically placed rectus sheath catheters are sited during wound closure and then bolused with local anesthetic just prior to emergence so often the block is not fully established in the early post-operative period resulting in further opiate analgesia requirement.
The primary objective is to demonstrate that in patients undergoing major urologic surgery PCA opioid consumption in the first 24 hours after surgery will be significantly less in patients who have had an ultrasound-guided single shot rectus sheath block pre-operatively in addition to a post-operative rectus sheath continuous block via surgically placed catheter versus those who only have post-operative rectus sheath continuous block.
Secondary outcomes will be opiate requirement intra-operatively, Numerical Rating Scale (NRS) pain scores including pain score in PACU and score at 24 and 48 hours, incidence and severity of nausea, number of vomiting episodes, sedation scores, time to first bowel movement, time to first mobilization and duration of hospital stay.
Research Methods: A randomized, double-blinded controlled trial.
Subjects who meet eligibility criteria will be invited to participate in the study by the clinical care team or research assistant in the Preadmission Clinic. Informed consent will be obtained by the research assistant. Next, all eligible participants will be randomized to the treatment group i.e. pre-operative single shot bilateral rectus sheath blocks + post-operative catheters or the control group i.e. post-operative catheters.
Randomization will be conducted through stratified-blocked randomization with varying blocks of 4 to 6 according to a schedule not known to the investigators using a computerized algorithm. The patient, intra-operative anesthetist, the surgeon and the assessor will be blinded to the randomization assignment.
The treatment group will have pre-operative single shot bilateral rectus blocks with 20 ml of a ropivacaine / bupivacaine mixture per side. The control group will have a pre-operative sham subcutaneous injection of 1ml saline per side. Both groups will have bilateral rectus sheath catheters placed surgically at the end of the procedure. Under direct visualization, the surgeon will insert a standard nerve block catheter between the rectus abdominis muscle and the posterior rectus sheath lateral to the incision on both sides. The catheter will be fixed to skin via a specialized taping system. An infusion of 0.2% ropivacaine will be administered through the rectus sheath catheter (1ml / hour continuous infusion with 15 ml /hour bolus every 4 hours). All patients will receive an IV morphine or dilaudid PCA and adjunctive post-operative medication. Intra-operative morphine / dilaudid administered intra-operatively will be recorded as well as total morphine / dilaudid used in the first 24 hours. Anesthesia technique will be standardized for short-acting opioid use i.e. fentanyl. Peri-operative multimodal analgesia adjuncts will include ketamine 0.2mg/kg and dexamethasone 6mg. All patients will be pre-medicated with acetaminophen 1g and gabapentin 300mg pre-operatively.
Primary and secondary outcomes will be collected by the study team from the patient chart and accompanying records and through patient interview. Continuous variables will be analyzed using t-tests and categorical variables will be analyzed using chi-squared test.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The treatment group will have pre-operative ultrasound-guided single shot bilateral rectus sheath blocks with 20 ml of a ropivacaine / bupivacaine mixture per side.
Procedure: Rectus sheath block · Procedure: Bilateral rectus sheath catheter · Drug: Patient controlled opioid analgesia (PCA)
The control group will have a pre-operative sham ultrasound-guided subcutaneous injection of 1ml saline per side.
Procedure: Bilateral rectus sheath catheter · Drug: Patient controlled opioid analgesia (PCA) · Procedure: Subcutaneous injection saline placebo
Rectus sheath block under ultrasound
A nerve block catheter known as a continuous rectus sheath block is inserted by the surgeon at the end of the operation. An infusion of 0.2% ropivacaine is delivered through this for up to 48 hours post-operatively.
Patients in both groups will have PCA dilaudid or morphine prescribed for the post-operative period.
Subcutaneous injection of 1ml of normal saline under ultrasound guidance at the same site bilaterally as rectus sheath blockade is performed
Opioid requirement in first 24 hours after surgery
Opioid requirement in first 24 hours after surgery
Time frame: 24 hours
Intra-operative opioid requirement
Surgery times vary but on average the procedure being investigated takes 3 - 6 hours. Opioid administered during this time by the intra-operative anesthesiologist will be recorded for the study.
Time frame: 3 - 6 hours
(Numerical Rating Scale) NRS pain score at 24 and 48 hours
The NRS pain scale is a used to measure pain intensity. Patients are asked to rate their pain between 0 (no pain) and 10 (worst pain possible)
Time frame: 48 hours
Severity of Nausea
Rated as mild, moderate or severe by the patient
Time frame: 48 hours
Number of vomiting episodes
Number of discrete vomiting episodes per 24 hour period
Time frame: 48 hours
Use of anti-emetics
Name and total dose of anti-emetic per 24 hour period
Time frame: 48 hours
Sedation score
Patients will be rated as alert, drowsy, light sedation i.e. awakens with eye contact), moderate sedation (wakens to voice), deep sedation (wakes to physical stimulation but not to voice) and unrousable (no response to voice or physical stimulation).
Time frame: 48 hours
Time to first bowel movement
Time from end of surgery to first bowel movement.
Time frame: Up to 7 days
Time to first mobilization
Time from end of surgery to sitting on chair by bed
Time frame: 48 hours
Duration of hospital stay
Time from end of surgery to ready for discharge
Time frame: 7 - 14 days
Plan to share: No
Ran from Feb 2018 to primary completion in Feb 2019, 11 months.
Of 235 non-industry interventional studies with no phase under Urinary Bladder Neoplasms, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 70. This study's 11 months is below that.
Counting every sponsor, half of 244 studies reached it within 39 months; a quarter within 20 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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