A Phase 2 interventional study of Lidocaine hydrochloride, 1.0% and Bupivacaine hydrochloride, 0.5% in Procedural Pain Relief, Nephrostomy Tube (NT) and Interventional Radiology, sponsored by University of Alberta. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by University of Alberta · Phase 2, Interventional, and Supportive care
Among 17 studies in Pain, Procedural with a site in Canada — 4 open to participants now, 4 under way, none of them phase 3. Pain, Procedural · Canada.
Among the 17 studies in Pain, Procedural with a site in Canada, this one is the 13th largest by planned enrollment, is one of 4 that started in 2026, is the only one in phase 2, and was the 17th registered.
243 studies on the registry are indexed under Pain, Procedural; 66 are open to participants now.
Browse Pain, Procedural studies →4 of the 17 studies in Pain, Procedural with a site in Canada are open now. Recruiting first, the newest first:
St. Justine's Hospital · Sites in Canada
Ages 18+ · Women only
Marsha Campbell-Yeo · Sites in Canada
University of British Columbia · Sites in Canada
Ages 6–12 · Healthy volunteers
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 29 Pain, Procedural studies recruiting now, 13 (45%) set no upper age limit and 14 (48%) stop at 75 or younger; 14 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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17 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 1 · Phase 2 2 · Phase 3 1
First in 2008; this study’s year is marked. 4 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 32 is below the median of 90 across 229 interventional studies indexed under Pain, Procedural.
Median enrollment 62 across the 17 interventional studies. Of the 12 that completed or were terminated, 1 (8%) have results posted.
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None of the 17 has an industry lead sponsor. The 9 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 1 study filed under Pain, Procedural — fewer than ten, so there is no comparison to draw.
2 of the studies in Pain, Procedural with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07173231St. Justine's HospitalUse of VR for Diagnostic Hysteroscopy | 2027-05 |
| NCT07636330University of British ColumbiaVirtual Reality for Pain and Anxiety in Pediatric Dental Treatment | 2027-06-18 |
Add all 2 to your calendar (.ics) → With an account.
Among the 17 studies in Pain, Procedural with a site in Canada, from their registry updates:
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Nephrostomy tube placement involves inserting a small tube through the skin and soft tissues into the kidney's collecting system to provide external drainage of urine when flow to the bladder is obstructed. A local anesthetic is injected along the nephrostomy tract and adjacent to the renal capsule to provide pain relief during the procedure.
Published medical literature predominantly describes lidocaine as the medication of choice for perirenal local anesthesia. However, no professional society guideline mandating a specific local anesthetic as the "standard of care" for nephrostomy tube placement was identified in the literature. In clinical practice, lidocaine is predominantly used.
Bupivacaine is a longer-acting alternative to lidocaine that may provide more sustained post-procedure pain relief. Use of bupivacaine has been well established in other procedural settings such as laparoscopic trocar-site infiltration (commonly performed by general surgery and gynecology) and nephrostomy-tract infiltration during percutaneous nephrolithotomy (performed by urologists).
A small subset of interventional radiologists in the Edmonton Zone-informally estimated at 2 out of 10-use bupivacaine for perirenal local anesthesia during percutaneous nephrostomy tube placement. These interventional radiologists anecdotally report better post-procedure pain control than with lidocaine for perirenal anesthesia. However, bupivacaine use for perirenal local anesthesia during nephrostomy tube placement has not been formally studied.
Our study aims to determine whether bupivacaine, compared with lidocaine, reduces pain during early recovery when used for perinephric local anesthesia.
We propose a prospective, randomized, controlled study with single-blinded outcome assessment. Patients undergoing percutaneous nephrostomy tube insertion will be randomized to receive either lidocaine or bupivacaine for perinephric local anesthesia. Participants will rate their pain at scheduled intervals after the procedure. Pain assessments will be performed by the site's nurse coordinator, who will be blinded to the local anesthetic technique used for each patient. We will compare pain scores and additional analgesic requirements between the two groups.
We expect patients receiving bupivacaine to experience significantly better post-procedure pain control than those receiving lidocaine. The findings may guide local anesthetic selection and ultimately improve comfort during recovery from nephrostomy tube placement.
Purpose
To determine whether use of a long-acting local anesthetic (bupivacaine), compared with lidocaine, improves early post-procedure pain control when used for perinephric local anesthesia.
Hypothesis
We hypothesize that patients undergoing percutaneous nephrostomy tube placement will report lower pain scores during immediate post-procedure recovery when bupivacaine, rather than lidocaine, is used for perinephric local anesthesia.
Justification
Lidocaine alone remains the standard local anesthetic for perinephric infiltration during percutaneous nephrostomy tube placement, but its analgesic effects are relatively short-lived. Bupivacaine offers longer-lasting analgesia, with local infiltration typically providing 4-8 hours of relief compared with 0.5-2 hours for lidocaine. (1,2)
Several randomized controlled trials (RCTs) in percutaneous nephrolithotomy have evaluated infiltration of 20 mL of 0.25% bupivacaine along the nephrostomy tract, from the renal capsule to the skin. These studies reported lower postoperative pain scores and reduced analgesic requirements, including a longer time to first opioid request, lower total opioid consumption over 48 hours, and lower visual analogue scale (VAS) pain scores at multiple postoperative time points. (3,4,5)
Evidence from laparoscopic surgery also supports the analgesic benefits of local bupivacaine infiltration. A meta-analysis of 20 RCTs in gynecologic laparoscopy (n = 1,861) found reduced pain at 4 and 6 hours following port-site local anesthetic infiltration. (6) A multicenter, double-blind RCT of laparoscopic hysterectomy (n = 108) found that subcutaneous port-site infiltration with 0.5% bupivacaine reduced pain scores through 48 hours and decreased rescue analgesic use. (7) Similarly, combined cystic plate and port-site injection of 0.25% bupivacaine reduced early postoperative pain following laparoscopic cholecystectomy. (8)
In the Edmonton Zone, interventional radiologists who have used bupivacaine for perinephric infiltration during nephrostomy tube placement report improved postprocedural pain control compared with lidocaine. To our knowledge, no study has specifically evaluated perirenal bupivacaine infiltration for pain control following percutaneous nephrostomy tube insertion. A prospective, randomized controlled study with blinded outcome assessment is therefore warranted to determine whether bupivacaine provides significantly better postprocedural pain control than lidocaine. The findings may guide local anesthetic selection and ultimately improve patient comfort during recovery from nephrostomy tube placement.
Objectives
The primary objective is to determine whether perinephric infiltration of bupivacaine, compared with lidocaine, improves early post-procedure pain control in patients undergoing percutaneous nephrostomy tube placement, as measured by pain scores during immediate recovery.
Research Methods
This will be a prospective, randomized, controlled study with single-blinded outcome assessment within the Edmonton Zone Interventional Radiology service.
Patients referred to the interventional radiology service who meet the established clinical indications for percutaneous nephrostomy tube placement will be considered for enrollment. Upon arrival in the pre-procedural area, patients will first undergo the standard clinical consent process for the medically indicated nephrostomy procedure. Clinical consent will be documented in the patient's health record in accordance with local institutional policy. This clinical consent is distinct from, and does not constitute, consent to participate in research. After the clinical indication for nephrostomy placement has been established and clinical consent for the procedure has been obtained-or, where clinically appropriate, during the same pre-procedural encounter but as a clearly separate discussion-the patient will be approached about participating in this research study.
A member of the research team will review the REB-approved research informed consent form with the patient. The discussion will explain that the patient is being invited to participate in a research study comparing early post-procedure pain after clinically indicated percutaneous nephrostomy tube placement using standard lidocaine perirenal anesthesia versus bupivacaine perirenal anesthesia. It will also explain that the nephrostomy insertion remains clinically indicated; the study compares the local-anesthetic approach, and the patient will be asked to rate pain on a 0-10 Visual Analog Scale during routine recovery-room assessments over approximately four hours. The discussion will cover the possible benefit of improved immediate pain control (which is not guaranteed), potential local-anesthetic risks, including systemic toxicity, and planned dose limits and monitoring. Confidentiality, data-handling procedures, and the voluntary nature of participation will also be discussed. Patients willing to participate will be asked to provide written, signed informed consent.
All patients will be de-identified and assigned an ID code. Outcome data for each patient will be entered into a database and linked to the corresponding de-identified ID code. All de-identified data will be stored in an encrypted file on a password-protected laptop. All subsequent analyses will use the de-identified data. Participants will include adult inpatients and outpatients presenting to a tertiary hospital for percutaneous nephrostomy tube placement. Exclusion criteria will include a contraindication to bupivacaine, an inability to complete protocolized pain scoring, or evere hepatic impairment, defined as Child-Pugh Class C (total score 10-15).
After providing informed consent, each participant will be randomized in a 1:1 ratio to the lidocaine or bupivacaine group using a computer-generated allocation sequence managed by the research coordinator. For each participant, the coordinator will retrieve the next assignment and communicate it before the procedure. The interventional radiologists performing the procedure will not have access to the allocation sequence or know upcoming assignments in advance.
The comparator will be standard lidocaine peri-renal anesthesia, consistent with usual practice, including tract infiltration to the level of the renal capsule. The intervention will be infiltration of 0.5% bupivacaine hydrochloride (Sensorcaine; Aspen Pharmacare Canada Inc., Oakville, ON, Canada) along the nephrostomy tract and adjacent to the renal capsule under image guidance.
Safety measures will ensure that the amount of local anesthetic used remains below the maximum dose. Specifically, participants assigned to the bupivacaine group will receive 0.5% bupivacaine (5 mg/mL) along the nephrostomy tract and around the renal capsule. The maximum planned volume for 0.5% bupivacaine peri-renal infiltration will be 10 mL per side (50 mg per side), with a maximum of 20 mL (100 mg) for bilateral procedures. Participants assigned to the lidocaine group will receive 1.0% lidocaine (10 mg/mL) in a similar manner along the nephrostomy tract and around the renal capsule. The maximum planned volume for 1.0% lidocaine peri-renal infiltration will be 10 mL per side (100 mg per side), with a maximum of 20 mL (200 mg) for bilateral procedures. The actual volume will be adjusted for the participant's weight, clinical factors, and any lower applicable dose limit; the maximum dose permitted by the applicable product monograph and institutional guidance will not be exceeded. Patients with severe hepatic impairment, defined as Child-Pugh Class C (total score 10-15) will be excluded from the study. The administered concentrations, volumes, and total doses will be documented, and participants will receive routine clinical monitoring for adverse effects.
Outcomes and data collection will include pain scores collected in the diagnostic imaging recovery room according to the site's standard schedule (e.g., q15 min × 4, q30 min × 2, q1 h × 2 over a 4-hour recovery period) using the Visual Analog Scale (VAS). Before the procedure, patients will be educated about the importance of self-reported pain assessment and how to use the VAS, which ranges from 0 ("no pain") to 10 ("worst possible pain"). Pain assessments will be performed by the site's nurse coordinator, who will be blinded to the local anesthetic technique used for each patient. Patient and procedural variables (e.g., inpatient vs outpatient status, sedation, laterality, and procedure duration/complexity) will be captured where available to describe comparability and explore potential confounding variables.
In summary, participants will be asked to provide written informed consent and report their pain using a standardized pain scale (VAS) at routine post-procedure recovery time points over approximately four hours. No procedures beyond standard nephrostomy tube placement will be required. Clinical teams will provide local anesthetic according to the assigned protocol and record standard procedural variables. Recovery nursing staff will document pain scores and analgesic administration as part of usual care, with study-specific data extracted under a coded study ID.
Plan for Data Analysis
Sample size was estimated using a power analysis informed by a prior study evaluating bupivacaine for postoperative pain control after percutaneous nephrolithotomy. (4) In that study, the mean pain score at 4 hours was 4.4 (SD 2.3). Assuming a two-sided α of 0.05, detecting a 1.5-point reduction in pain score with 80% power requires a minimum of 16 participants per group. (9)
Primary analyses will compare post-procedure pain between groups 4-hour recovery period. Categorical variables will be compared using chi-square testing or Fisher's exact test, as appropriate. Continuous outcomes will be assessed for normality and summarized accordingly: normally distributed data will be compared using a two-sample t-test and reported as mean ± SD, whereas non-normally distributed data will be compared using the Wilcoxon rank-sum test and reported as median (range). All tests will be two-sided, and p \< 0.05 will be considered statistically significant.
References
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive 1.0% lidocaine infiltrated along the nephrostomy tract and adjacent to the renal capsule. The planned maximum is 10 mL (100 mg) per side, or 20 mL (200 mg) for bilateral procedures.
Drug: Lidocaine hydrochloride, 1.0%
Participants will receive 0.5% bupivacaine hydrochloride infiltrated along the nephrostomy tract and adjacent to the renal capsule under image guidance. The planned maximum is 10 mL (50 mg) per side, or 20 mL (100 mg) for bilateral procedures.
Drug: Bupivacaine hydrochloride, 0.5%
Lidocaine will be infiltrated along the nephrostomy tract and adjacent to the renal capsule during nephrostomy tube placement. The planned maximum is 10 mL (100 mg) per side, or 20 mL (200 mg) for bilateral procedures.
Bupivacaine will be infiltrated along the nephrostomy tract and adjacent to the renal capsule under image guidance during nephrostomy tube placement. The planned maximum is 10 mL (50 mg) per side, or 20 mL (100 mg) for bilateral procedures.
Also known as: Snsoricaine, Marcaine
Post-procedure pain during recovery
Patient-reported pain following percutaneous nephrostomy tube placement will be assessed using the validated Visual Analog Scale (VAS), ranging from 0 ("no pain") to 10 ("worst possible pain"). Scores will be collected at routine recovery-room assessments over approximately four hours and compared between the bupivacaine and lidocaine groups.
Time frame: Approximately four hours after the procedure.
Plan to share: No
Start is estimated for Dec 2026; primary completion for Dec 2027, 12 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Bupivacaine