Kidney Transplant; ComplicationsPhase 4NCT05044429
Postoperative Pain Control Following Renal Transplant
A Phase 4 study testing Intravenous Lidocaine, Transversus abdominis plane (TAP) block and Quadratus Lumborum (QL) Block in people with Kidney Transplant; Complications and Pain, Postoperative, run by George Washington University at 1 site in United States.
Trial summary
This study aims to compare the effectiveness of a regional anesthetic block vs systemic intravenous (IV) lidocaine in controlling post-operative pain in kidney transplantation patients. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Kidney Transplant; Complications, Pain, Postoperative
- What is being tested?
- Intravenous Lidocaine, Transversus abdominis plane (TAP) block and Quadratus Lumborum (QL) Block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2021to 29 Nov 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral renal transplant
Who cannot join
- History of chronic pain, chronic opioid use, or opioid use disorder
- Cardiac arrythmia, cardiac failure
- Hepatic Failure
- Local anesthetic allergy (allergy to lidocaine and ropivacaine)
- Complicated surgical course including intraoperative damage to other organs (bowel)
- Return to operating room within 72hours
Trial locations and contacts
1 site in 1 country.
United States1 site
George Washington University Hospital
Washington D.C., District of Columbia, 20037
About this study
Official title: Postoperative Pain Control With Systemic Lidocaine vs. Regional Anesthesia in Renal Transplant Patients
This study aims to compare the effectiveness of a regional anesthetic block vs systemic intravenous (IV) lidocaine in controlling post-operative pain in kidney transplantation patients. Regional anesthetic blocks and lidocaine infusions are effective alternatives to opioid medications and are already in use at many institutions. However, there has been no prospective study comparing their effectiveness when used in conjunction with the current standard of care patient controlled analgesia (PCA) pumps. This study is a prospective, randomized evaluation of both treatment methods.
Read the detailed description
Adequate postoperative pain control is an important part of the patients' recovery. Renal transplant patients often have multiple comorbidities, that when combined with poorly controlled postoperative pain, can lead to tachycardia, hypertension, and increased risk of respiratory complications, which can in turn affect overall recovery and graft survival.
The use of patient-controlled analgesia (PCA) pumps is currently considered the standard of care in treating surgical pain in the immediate postoperative period. Although a traditional mainstay of therapy, opioids have an unfavorable side effect profile that includes respiratory depression, nausea, postoperative ileus, sedation, and pruritus. Additionally, long-term opioid use is linked with opioid tolerance, addiction, and patient death. Patients that have high-level opioid use in the first year posttransplant have been found to have high rates of death and all-cause graft failure.
Recently, there has been a shift in post-operative pain management to utilize a multimodal approach of both non-pharmacologic and pharmacologic therapies. As a result, the use of other non-opioid therapies, such as lidocaine infusions and regional anesthetic techniques, like transverse abdominis plane blocks, have recently increased in popularity in perioperative pain management of renal transplant patients.
Intravenous lidocaine has an off label indication as analgesic and has good evidence for use in other areas such as colorectal surgery, trauma and orthopedics. Lidocaine infusions have a strong record of safety with relatively benign adverse side effects. Although data is promising, there is little established evidence of perioperative lidocaine infusions in renal transplant populations.
Transverse abdominis plane (TAP) blocks and quadratus lumborum (QL) blocks have emerged as a significant regional technique in the application of multimodal analgesia for abdominal surgeries. Historically, TAP and QL catheters are avoided due to concern about infection near the operative site in immunosuppressed transplant patients. Establishing intravenous lidocaine as an effective treatment option will allow physicians to avoid the side effects of opioids and the infection risks of TAP and QL catheter blocks.
- Being tested
- Intravenous Lidocaine, Transversus abdominis plane (TAP) block, Quadratus Lumborum (QL) Block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous LidocaineDrug
Patient will receive intravenous lidocaine 1.0-1.5 mg/kg/hour for 48 hours post-operatively in addition to standard of care (patient-controlled analgesia (PCA) pump)
Transversus abdominis plane (TAP) blockDrug
Subject will receive 0.2% Ropivacaine at 6-10ml/hour through transversus abdominis plane (TAP) block for up to five days post-operatively in addition to standard of care (patient-controlled analgesia (PCA) pump)
Quadratus Lumborum (QL) BlockDrug
Subject will receive 0.2% Ropivacaine at 6-10ml/hour through quadratus lumborum (QL) block for up to five days post-operatively in addition to standard of care (patient-controlled analgesia (PCA) pump)
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Lidocaine | Experimental | Not described Receives: Drug: Intravenous Lidocaine |
| Transversus abdominis plane (TAP) block | Active comparator | Not described Receives: Drug: Transversus abdominis plane (TAP) block |
| Quadratus Lumborum (QL) Block | Active comparator | Not described Receives: Drug: Quadratus Lumborum (QL) Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Utilization (12 Hour Post-operative)
We are measuring oral morphine equivalents to assess for study intervention efficacy at 12 hours after surgery
Measured: 12 hours after surgery
Opioid Utilization (24 Hour Post-operative)
We are measuring oral morphine equivalents to assess for study intervention efficacy at 24 hours after surgery
Measured: 24 hours after surgery
Opioid Utilization (36 Hour Post-operative)
We are measuring oral morphine equivalents to assess for study intervention efficacy at 36 hours after surgery
Measured: 36 hours after surgery
Opioid Utilization (48 Hour Post-operative)
We are measuring oral morphine equivalents to assess for study intervention efficacy at 48 hours after surgery
Measured: 48 hours after surgery
Pain Level (12 Hour Post-operative)
Measured using visual analog scale (0-10), 0 is the best and 10 is the worst score at 12 hours after surgery
Measured: 12 hours after surgery
Pain Level (24 Hour Post-operative)
Measured using visual analog scale (0-10), 0 is the best and 10 is the worst score at 24 hours after surgery
Measured: 24 hours after surgery
Pain Level (36 Hour Post-operative)
Measured using visual analog scale (0-10), 0 is the best and 10 is the worst score at 36 hours after surgery
Measured: 36 hours after surgery
Pain Level (48 Hour Post-operative)
Measured using visual analog scale (0-10), 0 is the best and 10 is the worst score at 48 hours after surgery
Measured: 48 hours after surgery
Secondary outcomes (9)
Number of Subjects With Postoperative Sepsis
We will be assessing for a number of patients with post-operative infection that requires intravenous antibiotics
Measured: Through hospital discharge, approximately three days
Number of Acute Rejection of Renal Transplant
Occurs when the immune system identifies a grafted organ as foreign and attacks it
Measured: Up to one week
Number of Subjects With Local Anesthetic Systemic Toxicity (LAST)
A life-threatening adverse reaction resulting from local anesthetic reaching significant systemic circulating levels
Measured: Through hospital discharge, approximately four days
Number of Patients Who Need Continuous Veno-venous Hemodiafiltration (CVVHDF) After Renal Transplant
Temporary treatment for patients with acute renal failure
Measured: By time of hospital discharge, approximately four days
Number of Patients With Symptoms of Opioid Toxicity After Renal Transplant
Opioid toxicity requiring naloxone
Measured: Through hospital discharge, approximately four days
Number of Patients With Ileus After Renal Transplant
Painful obstruction of the ileum or other part of the intestine
Measured: Through hospital discharge, approximately four days
Total Length of Hospital Stay
Transplant time to discharge time
Measured: Through hospital discharge, approximately four days
Length of Intensive Care Unit Stay
Number of days spent in the intensive care unit following transplant
Measured: Through hospital discharge, approximately four days
Vital Status
Alive or dead at time of hospital discharge
Measured: Through hospital discharge, approximately four days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start16 Mar 2021
- Primary completion29 Nov 2023
- Study completion29 Nov 2023
Why it stopped: Lack of interest for continuing on by PI and issues with IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Heinz, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044429
- Sponsor's protocol ID
- NCR202221
- Status last verified
- Mar 2024
- First submitted
- 13 Apr 2021
- Last updated
- 18 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Farag E, Guirguis MN, Helou M, Dalton JE, Ngo F, Ghobrial M, O'Hara J, Seif J, Krishnamurthi V, Goldfarb D. Continuous transversus abdominis plane block catheter analgesia for postoperative pain control in renal transplant. J Anesth. 2015 Feb;29(1):4-8. doi: 10.1007/s00540-014-1855-1. Epub 2014 Jun 5.
PubMed 24898186Beaussier M, Delbos A, Maurice-Szamburski A, Ecoffey C, Mercadal L. Perioperative Use of Intravenous Lidocaine. Drugs. 2018 Aug;78(12):1229-1246. doi: 10.1007/s40265-018-0955-x.
PubMed 30117019Rahendra R, Pryambodho P, Aditianingsih D, Sukmono RB, Tantri A, Melati AC. Comparison of IL-6 and CRP Concentration Between Quadratus Lumborum and Epidural Blockade Among Living Kidney Donors: A Randomized Controlled Trial. Anesth Pain Med. 2019 Apr 28;9(2):e91527. doi: 10.5812/aapm.91527. eCollection 2019 Apr.
PubMed 31341831
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain Control With Systemic Lidocaine vs. Regional Anesthesia in Renal Transplant Patients
- ClinicalTrials.gov ID
- NCT05044429
- Acronym / sponsor ID
- NCR202221
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of interest for continuing on by PI and issues with IRB
- Enrolment
- 31 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 14 Sep 2021 (actual)
- Results
- Posted 18 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare the effectiveness of a regional anesthetic block vs systemic intravenous (IV) lidocaine in controlling post-operative pain in kidney transplantation patients. Regional anesthetic blocks and lidocaine infusions are effective alternatives to opioid medications and are already in use at many institutions. However, there has been no prospective study comparing their effectiveness when used in conjunction with the current standard of care patient controlled analgesia (PCA) pumps. This study is a prospective, randomized evaluation of both treatment methods.
Detailed description
Adequate postoperative pain control is an important part of the patients' recovery. Renal transplant patients often have multiple comorbidities, that when combined with poorly controlled postoperative pain, can lead to tachycardia, hypertension, and increased risk of respiratory complications, which can in turn affect overall recovery and graft survival.
The use of patient-controlled analgesia (PCA) pumps is currently considered the standard of care in treating surgical pain in the immediate postoperative period. Although a traditional mainstay of therapy, opioids have an unfavorable side effect profile that includes respiratory depression, nausea, postoperative ileus, sedation, and pruritus. Additionally, long-term opioid use is linked with opioid tolerance, addiction, and patient death. Patients that have high-level opioid use in the first year posttransplant have been found to have high rates of death and all-cause graft failure.
Recently, there has been a shift in post-operative pain management to utilize a multimodal approach of both non-pharmacologic and pharmacologic therapies. As a result, the use of other non-opioid therapies, such as lidocaine infusions and regional anesthetic techniques, like transverse abdominis plane blocks, have recently increased in popularity in perioperative pain management of renal transplant patients.
Intravenous lidocaine has an off label indication as analgesic and has good evidence for use in other areas such as colorectal surgery, trauma and orthopedics. Lidocaine infusions have a strong record of safety with relatively benign adverse side effects. Although data is promising, there is little established evidence of perioperative lidocaine infusions in renal transplant populations.
Transverse abdominis plane (TAP) blocks and quadratus lumborum (QL) blocks have emerged as a significant regional technique in the application of multimodal analgesia for abdominal surgeries. Historically, TAP and QL catheters are avoided due to concern about infection near the operative site in immunosuppressed transplant patients. Establishing intravenous lidocaine as an effective treatment option will allow physicians to avoid the side effects of opioids and the infection risks of TAP and QL catheter blocks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intravenous Lidocaine | Experimental | Drug: Intravenous Lidocaine |
| Transversus abdominis plane (TAP) block | Active comparator | Drug: Transversus abdominis plane (TAP) block |
| Quadratus Lumborum (QL) Block | Active comparator | Drug: Quadratus Lumborum (QL) Block |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Unilateral renal transplant
Key exclusion criteria (6 listed)
- History of chronic pain, chronic opioid use, or opioid use disorder
- Cardiac arrythmia, cardiac failure
- Hepatic Failure
- Local anesthetic allergy (allergy to lidocaine and ropivacaine)
- Complicated surgical course including intraoperative damage to other organs (bowel)
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 |
|---|---|---|
| Intravenous LidocainePatient will receive intravenous lidocaine 1.0-1.5 mg/kg/hour for 48 hours post-operatively in addition to standard of care (patient-controlled analgesia (PCA) pump) | Drug | Intravenous Lidocaine |
| Transversus abdominis plane (TAP) blockSubject will receive 0.2% Ropivacaine at 6-10ml/hour through transversus abdominis plane (TAP) block for up to five days post-operatively in addition to standard of care (patient-controlled analgesia (PCA) pump) | Drug | Transversus abdominis plane (TAP) block |
| Quadratus Lumborum (QL) BlockSubject will receive 0.2% Ropivacaine at 6-10ml/hour through quadratus lumborum (QL) block for up to five days post-operatively in addition to standard of care (patient-controlled analgesia (PCA) pump) | Drug | Quadratus Lumborum (QL) Block |
Primary outcome
Opioid Utilization (12 Hour Post-operative)
Time frame: 12 hours after surgery
We are measuring oral morphine equivalents to assess for study intervention efficacy at 12 hours after surgery
Opioid Utilization (24 Hour Post-operative)
Time frame: 24 hours after surgery
We are measuring oral morphine equivalents to assess for study intervention efficacy at 24 hours after surgery
Opioid Utilization (36 Hour Post-operative)
Time frame: 36 hours after surgery
We are measuring oral morphine equivalents to assess for study intervention efficacy at 36 hours after surgery
Opioid Utilization (48 Hour Post-operative)
Time frame: 48 hours after surgery
We are measuring oral morphine equivalents to assess for study intervention efficacy at 48 hours after surgery
Pain Level (12 Hour Post-operative)
Time frame: 12 hours after surgery
Measured using visual analog scale (0-10), 0 is the best and 10 is the worst score at 12 hours after surgery
Pain Level (24 Hour Post-operative)
Time frame: 24 hours after surgery
Measured using visual analog scale (0-10), 0 is the best and 10 is the worst score at 24 hours after surgery
Pain Level (36 Hour Post-operative)
Time frame: 36 hours after surgery
Measured using visual analog scale (0-10), 0 is the best and 10 is the worst score at 36 hours after surgery
Pain Level (48 Hour Post-operative)
Time frame: 48 hours after surgery
Measured using visual analog scale (0-10), 0 is the best and 10 is the worst score at 48 hours after surgery
9 secondary outcomes
Number of Subjects With Postoperative Sepsis
Time frame: Through hospital discharge, approximately three days
Number of Acute Rejection of Renal Transplant
Time frame: Up to one week
Number of Subjects With Local Anesthetic Systemic Toxicity (LAST)
Time frame: Through hospital discharge, approximately four days
Number of Patients Who Need Continuous Veno-venous Hemodiafiltration (CVVHDF) After Renal Transplant
Time frame: By time of hospital discharge, approximately four days
Number of Patients With Symptoms of Opioid Toxicity After Renal Transplant
Time frame: Through hospital discharge, approximately four days
Number of Patients With Ileus After Renal Transplant
Time frame: Through hospital discharge, approximately four days
Total Length of Hospital Stay
Time frame: Through hospital discharge, approximately four days
Length of Intensive Care Unit Stay
Time frame: Through hospital discharge, approximately four days
Vital Status
Time frame: Through hospital discharge, approximately four days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24898186Farag E, Guirguis MN, Helou M, Dalton JE, Ngo F, Ghobrial M, O'Hara J, Seif J, Krishnamurthi V, Goldfarb D. Continuous transversus abdominis plane block catheter analgesia for postoperative pain control in renal transplant. J Anesth. 2015 Feb;29(1):4-8. doi: 10.1007/s00540-014-1855-1. Epub 2014 Jun 5.
- Background: PubMed 30117019Beaussier M, Delbos A, Maurice-Szamburski A, Ecoffey C, Mercadal L. Perioperative Use of Intravenous Lidocaine. Drugs. 2018 Aug;78(12):1229-1246. doi: 10.1007/s40265-018-0955-x.
- Background: PubMed 31341831Rahendra R, Pryambodho P, Aditianingsih D, Sukmono RB, Tantri A, Melati AC. Comparison of IL-6 and CRP Concentration Between Quadratus Lumborum and Epidural Blockade Among Living Kidney Donors: A Randomized Controlled Trial. Anesth Pain Med. 2019 Apr 28;9(2):e91527. doi: 10.5812/aapm.91527. eCollection 2019 Apr.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous Lidocaine, Transversus abdominis plane (TAP) block and Quadratus Lumborum (QL) Block in people with Kidney Transplant; Complications and Pain, Postoperative, run by George Washington University at 1 site in United States.
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 1 inclusion and 6 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 18 Mar 2024. 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 United States. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Opioid Utilization (12 Hour Post-operative) (time frame: 12 hours after surgery). The study lists 8 primary outcomes in all. 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 NCT05044429, 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 18 Mar 2024.