Kidney CancerESPBNCT04085237
ESP Block for Laparoscopic Nephrectomy Surgeries
A study testing Ropivacaine injection in people with Kidney Cancer and Post-surgical Pain, run by McMaster University at 1 site in Canada.
Trial summary
Nephrectomy (kidney removal) is one of the most common surgical procedures in urologic practice. Recent advances in laparoscopic (keyhole) procedures have resulted in a significant decrease in open nephrectomies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer, Post-surgical Pain
- What is being tested?
- Ropivacaine injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jan 2020to 16 Oct 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring laparoscopic nephrectomy and partial nephrectomy for malignancy
- Patients of age 18 and over
- BMI < 40
- Patients who are expected to stay in-hospital overnight after surgery
Who cannot join
- Patient refusal
- Contraindications to paravertebral blocks: Infection at the site of needle insertion, empyema, allergy to local anesthetic drugs, and tumor occupying the thoracic paravertebral space, coagulopathy, bleeding disorder or therapeutic anticoagulation
- Known allergy to local anesthetics
- Inability to provide informed consent
- Inability to use a PCA due to languate or comprehension barriers
- BMI >= 40
Show all 10Show fewer
- Any patient on opioids for greater than or equal to 3 months duration prior to surgery
- Patients with chronic pain syndromes
- Donor nephrectomies due to incision location
- Cystic kidney because of very large incisions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Benefit of Adding Ultrasound-guided ESP Block to PCA vs. PCA Alone for Postoperative Analgesia After Laparoscopic Nephrectomy Surgeries: a Pilot, Randomized Controlled Trial
Nephrectomy (kidney removal) is one of the most common surgical procedures in urologic practice. Recent advances in laparoscopic (keyhole) procedures have resulted in a significant decrease in open nephrectomies. Most laparoscopic surgeries are performed through 3 to 4 small (1 to 1.5 cm) incisions; however, laparoscopic nephrectomies for cancer include one of the incisions being extended to 7 to 10 cm for kidney removal. Although pain after laparoscopic surgery is somewhat less than that after open surgery, it is still significant, and opioid consumption is similar. Opioids have been a mainstay for the treatment of post-operative pain, but they are associated with many adverse effects and a potential for long-term use. Thus, combining opioid analgesia with other forms of analgesia has the potential to reduce opioid use. Paravertebral nerve blocks, where local anesthetic is injected near the spinal nerves, have recently shown good pain control in patients undergoing thoracic and abdominal surgeries. However, this technique is technically challenging, time consuming, and has the risk of significant side effects. Fascial plane blocks are an alternative to paravertebral blocks. Fascial plane blocks, where local anesthetic is injected in areas further away from the spinal nerves, are easier to perform than paravertebral blocks, and have fewer associated risks. A recently described fascial plane block, the Erector Spinae Plane (ESP) block, has been shown to be effective in controlling pain in a variety of surgeries. However, currently, there is little information regarding its use in laparoscopic nephrectomy. We are proposing this pilot randomized control trial to look at the feasibility of completing a larger randomized control trial to evaluate ESP blockade in patients undergoing laparoscopic nephrectomy for cancer. We will also investigate total opioid consumption, and pain scores at rest and during movement.
Read the detailed description
While post-operative pain seems to be slightly decreased compared to open nephrectomies, pain from laparoscopic nephrectomy is still significant and opioid consumption is similar.Adequate management of post-operative pain is imperative in early post-operative mobilization. ¬Although opioids have been a mainstay for the treatment of post-operative pain, other strategies should be considered as opioids are associated with adverse effects, the potential for long-term opioid use, and even death. There have been an increasing number of opioid related deaths with 2,066 apparent opioid-related deaths in Canada over the first half of 2018. With the need to address the worsening opioid crisis, it is essential that other non-opioid strategies are explored and considered. Multimodal anesthesia has been one effort to reduce opioid use post-operatively. Increasingly, the literature shows that peripheral nerve blocks reduce post-operative opioid consumption in a vast variety of surgeries.
Traditionally patients undergoing laparoscopic nephrectomy have opioid patient controlled analgesia pumps (PCAs) for post-operative pain control. PCA is widely recognized as an effective technique after laparoscopic nephrectomy to reduce pain scores. A meta-analysis of 49 articles showed PCA had better postoperative pain control than nurse administered analgesics over most time intervals with higher patient satisfaction. Complications of a PCA include respiratory depression, confusion or sedation, nausea, pruritus, ileus, and insufficient analgesia. Paravertebral blocks (PVB) have recently showed promise and increasing clinical uptake due to a growing use of ultrasound-guided regional anesthesia. They provide good pain control in patients undergoing thoracic and abdominal surgeries. In PVB, local anesthetic is injected near the thoracic spinal nerve at its exit from the intervertebral foramina, which results in unilateral somatic and sympathetic nerve blockade in multiple continuous thoracic dermatomes above and below the site of injection. However, this technique is technically challenging, time consuming, and carries a risk of pneumothorax. Fascial plane blocks are increasingly used as an alternative regional anesthetic strategy for abdominal surgery.
Recently ultrasound-guided Erector Spinae Plane (ESP) block was described in which local anesthetic is injected around the erector spinae muscle which tends to block the dorsal and ventral rami of the thoracic spinal nerves. There is growing evidence of its use in a wide range of surgeries. The appeal of the ESP block is in providing analgesia without the potential for needle pleura interaction and the consequent risk of pneumothorax. This interfascial block involves ultrasound guided injection of local anesthetics under the erector spinae muscle and superficial to transverse process of thoracic vertebrae at appropriate level. The ESP block targets the dorsal and ventral rami of the spinal nerves as they leave the intervertebral foramen. Cadaveric examination of ESP block showed extensive cranial-caudal spread of the block, approximately four dermatomes above and below the site of injection. The fact that the site of injection is distant from the spinal cord and pleura, increases the safety of the ESP block as compared to a paravertebral block. The transverse process is easily visualized on ultrasound and acts as a backstop for the needle, preventing excessively deep placement. Of importance, a catheter can also be placed easily during the ESP block allowing continuous infusion and prolonged analgesia. Given the importance of providing adequate analgesia in patients undergoing laparoscopic nephrectomy and the lack of consensus amongst surgeons and anesthesiologists for the optimal analgesic technique, we are proposing a pilot randomized controlled trial (RCT) to determine the feasibility of a larger RCT to compare continuous ESP blockade vs a Sham blockade. Both groups will receive opioid PCA and other multimodal analgesia combined with opioid PCA versus opioid PCA alone.
Literature review: We conducted a review via Pubmed looking at all studies associated with "erector spinae block". Of the studies found, 123 relevant studies were reviewed. The studies included 92 case reports and 4 randomized control trials, with the others being anatomical reviews, editorials, or small review articles. Of these, there were only 4 patients from 1 case series article where patients received ESP blocks for laparoscopic nephrectomies. None of these patients required post-operative opioids in addition to their ESP block infusions. We also reviewed clinicaltrials.gov for ongoing and proposed trials related to the ESP block. Currently, we identified 51 studies involving the ESP block. The vast majority of these revolved around thoracic and general surgery, including some randomized controlled trials. There was only 1 proposed trial studying the use of the ESP block with nephrectomies, but this one was evaluating surgeries
- Conditions
- Kidney Cancer, Post-surgical Pain
- Being tested
- Ropivacaine injection, Sham
- Medical subject headings
- Kidney Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine injectionDrug
Also called Naropin
30ml of 0.375% ropivacaine with 5mcg/ml of epinephrine will be injected into the fascial plane on the anterior spinae muscle.
ShamOther
Also called Placebo
Saline will be used at the same amounts as the ropivacaine arm.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided continuous ESP block with opioid PCA | Experimental | A high-frequency linear ultrasound transducer will be placed in a longitudinal parasagittal orientation 3 cm lateral to the T7/T8 spinous process. The patient's skin will be anesthetized with 2% lidocaine. A Contiplex Echo ultra 360 18G needle with 20G × 55 cm Contiplex Echo catheter will be inserted using an in-plane superior-to-inferior approach to place the tip into the fascial plane on the deep (anterior) aspect of erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process. A total of 30 mL of 0.375% ropivacaine with 5mcg/mL of epinephrine will be injected in 5-mL aliquots through the needle (maximum of 3mg/kg) followed by insertion of the echo catheter system under direct vision 2-3 cm beyond the needle tip. Receives: Drug: Ropivacaine injection |
| Ultrasound-guided sham block and catheter with opioid PCA | Sham comparator | The exact same procedure as the experimental group will be followed, substituting saline for local anesthetic at the same amounts and rate. As with the ESP group, the patients will have PCA initiated postoperatively in the PACU at the same doses. Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Enrollment rate of greater than one patient per week with 100% in-hospital follow-up
Number of patients recruited per week
Measured: One week
Secondary outcomes (3)
Opioid Consumption
Total long acting opioid consumption in hydromorphone equivalents
Measured: 48 hours
Pain scores at rest and movement
Pain scores will be recorded at intervals. The Numerical Rating Scale (NRS) is an 11-point scale where 0 is no pain and 10 is the worst pain imaginable.
Measured: Day 1
Number of Adverse Events
Incidence of postoperative nausea-vomiting; respiratory depression; itching; local anesthetic toxicity; catheter leakage and catheter migration; infection at catheter site
Measured: Day 1-2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start4 Jan 2020
- Primary completion31 Dec 2020
- Study completion16 Oct 2023
Why it stopped: It was terminated because of poor recruitment rate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Kidney 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
- Model description
- Feasibility pilot study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Responsible party
- Sponsor
- Investigators
- Shahid Lambe, MD, Principal investigator, St. Joseph's Healthcare Hamilton and McMaster UniversityPeter Moisiuk, MD, Principal investigator, St. Joseph's Healthcare Hamilton and McMaster UniversityAaron Kugler, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085237
- Sponsor's protocol ID
- 7119
- Acronym
- ESPB
- Status last verified
- Feb 2024
- First submitted
- 9 Sep 2019
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alper I, Yuksel E. Comparison of Acute and Chronic Pain after Open Nephrectomy versus Laparoscopic Nephrectomy: A Prospective Clinical Trial. Medicine (Baltimore). 2016 Apr;95(16):e3433. doi: 10.1097/MD.0000000000003433.
PubMed 27100439Shah A, Rowlands M, Krishnan N, Patel A, Ott-Young A. Thoracic Intercostal Nerve Blocks Reduce Opioid Consumption and Length of Stay in Patients Undergoing Implant-Based Breast Reconstruction. Plast Reconstr Surg. 2015 Nov;136(5):584e-591e. doi: 10.1097/PRS.0000000000001717.
PubMed 26505714Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PubMed 27501016
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benefit of Adding Ultrasound-guided ESP Block to PCA vs. PCA Alone for Postoperative Analgesia After Laparoscopic Nephrectomy Surgeries: a Pilot, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04085237
- Acronym / sponsor ID
- ESPB / 7119
- Conditions
- Kidney Cancer, Post-surgical Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It was terminated because of poor recruitment rate.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Study start
- 4 Jan 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 16 Oct 2023 (actual)
- First posted
- 11 Sep 2019 (actual)
- 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.
Nephrectomy (kidney removal) is one of the most common surgical procedures in urologic practice. Recent advances in laparoscopic (keyhole) procedures have resulted in a significant decrease in open nephrectomies. Most laparoscopic surgeries are performed through 3 to 4 small (1 to 1.5 cm) incisions; however, laparoscopic nephrectomies for cancer include one of the incisions being extended to 7 to 10 cm for kidney removal. Although pain after laparoscopic surgery is somewhat less than that after open surgery, it is still significant, and opioid consumption is similar. Opioids have been a mainstay for the treatment of post-operative pain, but they are associated with many adverse effects and a potential for long-term use. Thus, combining opioid analgesia with other forms of analgesia has the potential to reduce opioid use. Paravertebral nerve blocks, where local anesthetic is injected near the spinal nerves, have recently shown good pain control in patients undergoing thoracic and abdominal surgeries. However, this technique is technically challenging, time consuming, and has the risk of significant side effects. Fascial plane blocks are an alternative to paravertebral blocks. Fascial plane blocks, where local anesthetic is injected in areas further away from the spinal nerves, are easier to perform than paravertebral blocks, and have fewer associated risks. A recently described fascial plane block, the Erector Spinae Plane (ESP) block, has been shown to be effective in controlling pain in a variety of surgeries. However, currently, there is little information regarding its use in laparoscopic nephrectomy. We are proposing this pilot randomized control trial to look at the feasibility of completing a larger randomized control trial to evaluate ESP blockade in patients undergoing laparoscopic nephrectomy for cancer. We will also investigate total opioid consumption, and pain scores at rest and during movement.
Detailed description
While post-operative pain seems to be slightly decreased compared to open nephrectomies, pain from laparoscopic nephrectomy is still significant and opioid consumption is similar.Adequate management of post-operative pain is imperative in early post-operative mobilization. ¬Although opioids have been a mainstay for the treatment of post-operative pain, other strategies should be considered as opioids are associated with adverse effects, the potential for long-term opioid use, and even death. There have been an increasing number of opioid related deaths with 2,066 apparent opioid-related deaths in Canada over the first half of 2018. With the need to address the worsening opioid crisis, it is essential that other non-opioid strategies are explored and considered. Multimodal anesthesia has been one effort to reduce opioid use post-operatively. Increasingly, the literature shows that peripheral nerve blocks reduce post-operative opioid consumption in a vast variety of surgeries.
Traditionally patients undergoing laparoscopic nephrectomy have opioid patient controlled analgesia pumps (PCAs) for post-operative pain control. PCA is widely recognized as an effective technique after laparoscopic nephrectomy to reduce pain scores. A meta-analysis of 49 articles showed PCA had better postoperative pain control than nurse administered analgesics over most time intervals with higher patient satisfaction. Complications of a PCA include respiratory depression, confusion or sedation, nausea, pruritus, ileus, and insufficient analgesia. Paravertebral blocks (PVB) have recently showed promise and increasing clinical uptake due to a growing use of ultrasound-guided regional anesthesia. They provide good pain control in patients undergoing thoracic and abdominal surgeries. In PVB, local anesthetic is injected near the thoracic spinal nerve at its exit from the intervertebral foramina, which results in unilateral somatic and sympathetic nerve blockade in multiple continuous thoracic dermatomes above and below the site of injection. However, this technique is technically challenging, time consuming, and carries a risk of pneumothorax. Fascial plane blocks are increasingly used as an alternative regional anesthetic strategy for abdominal surgery.
Recently ultrasound-guided Erector Spinae Plane (ESP) block was described in which local anesthetic is injected around the erector spinae muscle which tends to block the dorsal and ventral rami of the thoracic spinal nerves. There is growing evidence of its use in a wide range of surgeries. The appeal of the ESP block is in providing analgesia without the potential for needle pleura interaction and the consequent risk of pneumothorax. This interfascial block involves ultrasound guided injection of local anesthetics under the erector spinae muscle and superficial to transverse process of thoracic vertebrae at appropriate level. The ESP block targets the dorsal and ventral rami of the spinal nerves as they leave the intervertebral foramen. Cadaveric examination of ESP block showed extensive cranial-caudal spread of the block, approximately four dermatomes above and below the site of injection. The fact that the site of injection is distant from the spinal cord and pleura, increases the safety of the ESP block as compared to a paravertebral block. The transverse process is easily visualized on ultrasound and acts as a backstop for the needle, preventing excessively deep placement. Of importance, a catheter can also be placed easily during the ESP block allowing continuous infusion and prolonged analgesia. Given the importance of providing adequate analgesia in patients undergoing laparoscopic nephrectomy and the lack of consensus amongst surgeons and anesthesiologists for the optimal analgesic technique, we are proposing a pilot randomized controlled trial (RCT) to determine the feasibility of a larger RCT to compare continuous ESP blockade vs a Sham blockade. Both groups will receive opioid PCA and other multimodal analgesia combined with opioid PCA versus opioid PCA alone.
Literature review: We conducted a review via Pubmed looking at all studies associated with "erector spinae block". Of the studies found, 123 relevant studies were reviewed. The studies included 92 case reports and 4 randomized control trials, with the others being anatomical reviews, editorials, or small review articles. Of these, there were only 4 patients from 1 case series article where patients received ESP blocks for laparoscopic nephrectomies. None of these patients required post-operative opioids in addition to their ESP block infusions. We also reviewed clinicaltrials.gov for ongoing and proposed trials related to the ESP block. Currently, we identified 51 studies involving the ESP block. The vast majority of these revolved around thoracic and general surgery, including some randomized controlled trials. There was only 1 proposed trial studying the use of the ESP block with nephrectomies, but this one was evaluating surgeries
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Feasibility pilot study
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided continuous ESP block with opioid PCA | Experimental | Drug: Ropivacaine injectionA high-frequency linear ultrasound transducer will be placed in a longitudinal parasagittal orientation 3 cm lateral to the T7/T8 spinous process. The patient's skin will be anesthetized with 2% lidocaine. A Contiplex Echo ultra 360 18G needle with 20G × 55 cm Contiplex Echo catheter will be inserted using an in-plane superior-to-inferior approach to place the tip into the fascial plane on the deep (anterior) aspect of erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process. A total of 30 mL of 0.375% ropivacaine with 5mcg/mL of epinephrine will be injected in 5-mL aliquots through the needle (maximum of 3mg/kg) followed by insertion of the echo catheter system under direct vision 2-3 cm beyond the needle tip. |
| Ultrasound-guided sham block and catheter with opioid PCA | Sham comparator | Other: ShamThe exact same procedure as the experimental group will be followed, substituting saline for local anesthetic at the same amounts and rate. As with the ESP group, the patients will have PCA initiated postoperatively in the PACU at the same doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients requiring laparoscopic nephrectomy and partial nephrectomy for malignancy
- Patients of age 18 and over
- BMI < 40
- Patients who are expected to stay in-hospital overnight after surgery
Key exclusion criteria (10 listed)
- Patient refusal
- Contraindications to paravertebral blocks: Infection at the site of needle insertion, empyema, allergy to local anesthetic drugs, and tumor occupying the thoracic paravertebral space, coagulopathy, bleeding disorder or therapeutic anticoagulation
- Known allergy to local anesthetics
- Inability to provide informed consent
- Inability to use a PCA due to languate or comprehension barriers
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 |
|---|---|---|
| Ropivacaine injectionAlso: Naropin30ml of 0.375% ropivacaine with 5mcg/ml of epinephrine will be injected into the fascial plane on the anterior spinae muscle. | Drug | Ultrasound-guided continuous ESP block with opioid PCA |
| ShamAlso: PlaceboSaline will be used at the same amounts as the ropivacaine arm. | Other | Ultrasound-guided sham block and catheter with opioid PCA |
Primary outcome
Feasibility - Enrollment rate of greater than one patient per week with 100% in-hospital follow-up
Time frame: One week
Number of patients recruited per week
3 secondary outcomes
Opioid Consumption
Time frame: 48 hours
Pain scores at rest and movement
Time frame: Day 1
Number of Adverse Events
Time frame: Day 1-2
Results and safety
The study was stopped early (reason given: It was terminated because of poor recruitment rate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Results publication: PubMed 27100439Alper I, Yuksel E. Comparison of Acute and Chronic Pain after Open Nephrectomy versus Laparoscopic Nephrectomy: A Prospective Clinical Trial. Medicine (Baltimore). 2016 Apr;95(16):e3433. doi: 10.1097/MD.0000000000003433.
- Results publication: PubMed 26505714Shah A, Rowlands M, Krishnan N, Patel A, Ott-Young A. Thoracic Intercostal Nerve Blocks Reduce Opioid Consumption and Length of Stay in Patients Undergoing Implant-Based Breast Reconstruction. Plast Reconstr Surg. 2015 Nov;136(5):584e-591e. doi: 10.1097/PRS.0000000000001717.
- Results publication: PubMed 27501016Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
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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.
Shahid Lambe, MD principal investigator
St. Joseph's Healthcare Hamilton and McMaster University
Peter Moisiuk, MD principal investigator
St. Joseph's Healthcare Hamilton and McMaster University
Aaron Kugler, MD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine injection in people with Kidney Cancer and Post-surgical Pain, run by McMaster University 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 4 inclusion and 10 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: stopped early, as of the sponsor's last update on 4 Jun 2026. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: It was terminated because of poor recruitment rate.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - Enrollment rate of greater than one patient per week with 100% in-hospital follow-up (time frame: One week). 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 NCT04085237, which also lists 3 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 4 Jun 2026.