Pain, PostoperativePhase 3NCT04786470
Transversus Abdominis Plane Catheter Following Kidney Transplantation
A Phase 3 study testing Ropivacaine and Saline in people with Pain, Postoperative and Kidney Transplant, run by Western University, Canada.
Trial summary
Continuous Infusion of Local Anesthetic After Kidney Transplantation This is a phase III, randomized, double-blinded, sham-controlled trial comparing the use of a continuous infusion of local anesthetic via transversus abdominis plane (TAP) catheter to a saline infusion (sham) via TAP catheter along with standard… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Kidney Transplant
- What is being tested?
- Ropivacaine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- May 2021to Nov 2022
- Phase
- Phase 3
- 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
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male, female, non-binary gender, aged >18 years.
- Undergoing a kidney transplant (deceased or living donor) as treatment for stage 5 chronic kidney disease (Glomerular filtration rate < 15ml/min) either on dialysis, or approaching dialysis
- No history of allergy to any local anesthetic.
- Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration
Who cannot join
- Current use of opioid pain medications prior to kidney transplantation.
- Known allergic reactions to components of any local anesthetic medication.
- Prior local anesthetic systemic toxicity.
- History of chronic pain undergoing current active treatment for the same.
- Age <18 years (this analgesic approach has not been established in this population).
- Unable or unwilling to use IV PCA pump for any reason (manual dexterity, cognitive impairment, patient choice etc.).
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- Multi-visceral transplantation.
- Incision other than standard Gibson incision.
- Unilateral or bilateral nephrectomy at time of kidney transplant.
- Advanced liver disease.
Trial locations and contacts
No sites are listed yet.
Andrew C Rasmussen, MD contact
Ephraim Tang, MD contact
About this study
Continuous Infusion of Local Anesthetic After Kidney Transplantation
This is a phase III, randomized, double-blinded, sham-controlled trial comparing the use of a continuous infusion of local anesthetic via transversus abdominis plane (TAP) catheter to a saline infusion (sham) via TAP catheter along with standard postoperative analgesia in patients undergoing kidney transplantation. Patients will have a TAP catheter placed at the time of kidney transplantation by the surgical team under direct vision. They are then randomized to a continuous infusion of local anesthetic or saline for 48 hours postoperatively. Both groups will receive a standard postoperative analgesic regimen including a Patient Controlled Analgesic (PCA) pump and multimodal analgesics including acetaminophen and gabapentin.
- Conditions
- Pain, Postoperative, Kidney Transplant
- Being tested
- Ropivacaine, Saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Ropivacaine infusion via transversus abdominis plane catheter.
SalineDrug
Saline infusion via transversus abdominis plane catheter.
| Study group | Role | What they receive |
|---|---|---|
| Local Anaesthetic Infusion | Active comparator | Not described Receives: Drug: Ropivacaine |
| Saline Infusion | Sham comparator | Not described Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral morphine equivalent (OME)
OME in mg
Measured: 48 hours post kidney transplantation
Secondary outcomes (8)
Visual Analog Scale pain rating
Series of 5 faces that depict discomfort levels ranging from severe pain (score 5) to no pain at all (score 1). The higher the score, the more pain a patient has.
Measured: 12, 24, and 48 hours post kidney transplantation
Patient quality of life score
Measured: 48 hours post kidney transplantation
Time to return of bowel function postoperatively
Measured: Duration of admission
Incidence of local anesthetic systemic toxicity
Measured: Duration of admission
Postoperative adverse events (surgical)
Measured: Duration of admission
Delayed graft function
Defined as the requirement for hemodialysis/peritoneal dialysis within the first 7 days after kidney transplantation for any reason.
Measured: Duration of admission
Creatinine (mmol/L) at time of discharge
Measured: Duration of admission
Length of stay
Measured: Duration of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study startMay 2021 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Rasmussen, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786470
- Sponsor's protocol ID
- 116618
- Status last verified
- Mar 2021
- First submitted
- 3 Mar 2021
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transversus Abdominis Plane Catheter Following Kidney Transplantation
- ClinicalTrials.gov ID
- NCT04786470
- Acronym / sponsor ID
- 116618
- Conditions
- Pain, Postoperative, Kidney Transplant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 8 Mar 2021 (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.
Continuous Infusion of Local Anesthetic After Kidney Transplantation
This is a phase III, randomized, double-blinded, sham-controlled trial comparing the use of a continuous infusion of local anesthetic via transversus abdominis plane (TAP) catheter to a saline infusion (sham) via TAP catheter along with standard postoperative analgesia in patients undergoing kidney transplantation. Patients will have a TAP catheter placed at the time of kidney transplantation by the surgical team under direct vision. They are then randomized to a continuous infusion of local anesthetic or saline for 48 hours postoperatively. Both groups will receive a standard postoperative analgesic regimen including a Patient Controlled Analgesic (PCA) pump and multimodal analgesics including acetaminophen and gabapentin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local Anaesthetic Infusion | Active comparator | Drug: Ropivacaine |
| Saline Infusion | Sham comparator | Drug: Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male, female, non-binary gender, aged >18 years.
- Undergoing a kidney transplant (deceased or living donor) as treatment for stage 5 chronic kidney disease (Glomerular filtration rate < 15ml/min) either on dialysis, or approaching dialysis
- No history of allergy to any local anesthetic.
Key exclusion criteria (10 listed)
- Current use of opioid pain medications prior to kidney transplantation.
- Known allergic reactions to components of any local anesthetic medication.
- Prior local anesthetic systemic toxicity.
- History of chronic pain undergoing current active treatment for the same.
- Age <18 years (this analgesic approach has not been established in this population).
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 |
|---|---|---|
| RopivacaineRopivacaine infusion via transversus abdominis plane catheter. | Drug | Local Anaesthetic Infusion |
| SalineSaline infusion via transversus abdominis plane catheter. | Drug | Saline Infusion |
Primary outcome
Oral morphine equivalent (OME)
Time frame: 48 hours post kidney transplantation
OME in mg
8 secondary outcomes
Visual Analog Scale pain rating
Time frame: 12, 24, and 48 hours post kidney transplantation
Patient quality of life score
Time frame: 48 hours post kidney transplantation
Time to return of bowel function postoperatively
Time frame: Duration of admission
Incidence of local anesthetic systemic toxicity
Time frame: Duration of admission
Postoperative adverse events (surgical)
Time frame: Duration of admission
Delayed graft function
Time frame: Duration of admission
Creatinine (mmol/L) at time of discharge
Time frame: Duration of admission
Length of stay
Time frame: Duration of admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Andrew C Rasmussen, MD contact
Ephraim Tang, MD contact
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ropivacaine and Saline in people with Pain, Postoperative and Kidney Transplant, run by Western University, 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 6 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: status not confirmed, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Andrew C Rasmussen, MD (arasmuss@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral morphine equivalent (OME) (time frame: 48 hours post kidney transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Mar 2021.