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Lack of interest for continuing on by PI and issues with IRB
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Lidocaine | Experimental |
| |
| Transversus abdominis plane (TAP) block | Active Comparator |
| |
| Quadratus Lumborum (QL) Block | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Lidocaine | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Utilization (12 Hour Post-operative) | We are measuring oral morphine equivalents to assess for study intervention efficacy at 12 hours after surgery | 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 | 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 | 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 | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Postoperative Sepsis | We will be assessing for a number of patients with post-operative infection that requires intravenous antibiotics | Through hospital discharge, approximately three days |
| Number of Acute Rejection of Renal Transplant |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Washington University Hospital | Washington D.C. | District of Columbia | 20037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24898186 | Background | 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. | |
| 30117019 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intravenous Lidocaine | Intravenous Lidocaine: 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) |
| FG001 | Transversus Abdominis Plane (TAP) Block | Transversus abdominis plane (TAP) block: 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) |
| FG002 | Quadratus Lumborum (QL) Block | Quadratus Lumborum (QL) Block: 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intravenous Lidocaine | Intravenous Lidocaine: 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) |
| BG001 | Transversus Abdominis Plane (TAP) Block |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Opioid Utilization (12 Hour Post-operative) | We are measuring oral morphine equivalents to assess for study intervention efficacy at 12 hours after surgery | trial was terminated before the outcome measure data were collected | Posted | 12 hours after surgery |
|
7.5 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intravenous Lidocaine | Intravenous Lidocaine: 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) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | GWUniversity | 202-823-4259 | eheinz@mfa.gwu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 28, 2021 | Jan 25, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 18, 2021 | Jan 25, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D003766 | Dental Occlusion |
| ID | Term |
|---|---|
| D003813 | Dentistry |
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
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| Transversus abdominis plane (TAP) block | Drug | 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) Block | Drug | 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) |
|
| 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 | 48 hours after surgery |
Occurs when the immune system identifies a grafted organ as foreign and attacks it |
| 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 | 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 | By time of hospital discharge, approximately four days |
| Number of Patients With Symptoms of Opioid Toxicity After Renal Transplant | Opioid toxicity requiring naloxone | 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 | Through hospital discharge, approximately four days |
| Total Length of Hospital Stay | Transplant time to discharge time | Through hospital discharge, approximately four days |
| Length of Intensive Care Unit Stay | Number of days spent in the intensive care unit following transplant | Through hospital discharge, approximately four days |
| Vital Status | Alive or dead at time of hospital discharge | Through hospital discharge, approximately four days |
| Beaussier 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. |
| 31341831 | Background | Rahendra 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. |
Transversus abdominis plane (TAP) block: 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) |
| BG002 | Quadratus Lumborum (QL) Block | Quadratus Lumborum (QL) Block: 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) |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | trial was terminated before analysis of data | Number | participants |
|
| OG002 | Quadratus Lumborum (QL) Block | Quadratus Lumborum (QL) Block: 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) |
|
| Primary | Opioid Utilization (24 Hour Post-operative) | We are measuring oral morphine equivalents to assess for study intervention efficacy at 24 hours after surgery | trial was terminated before the outcome measure data were collected | Posted | 24 hours after surgery |
|
|
| Primary | Opioid Utilization (36 Hour Post-operative) | We are measuring oral morphine equivalents to assess for study intervention efficacy at 36 hours after surgery | trial was terminated before the outcome measure data were collected | Posted | 36 hours after surgery |
|
|
| Primary | Opioid Utilization (48 Hour Post-operative) | We are measuring oral morphine equivalents to assess for study intervention efficacy at 48 hours after surgery | trial was terminated before the outcome measure data were collected | Posted | 48 hours after surgery |
|
|
| Primary | 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 | trial was terminated before the outcome measure data were collected | Posted | 12 hours after surgery |
|
|
| Primary | 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 | trial was terminated before the outcome measure data were collected | Posted | 24 hours after surgery |
|
|
| Primary | 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 | trial was terminated before the outcome measure data were collected | Posted | 36 hours after surgery |
|
|
| Primary | 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 | trial was terminated before the outcome measure data were collected | Posted | 48 hours after surgery |
|
|
| Secondary | Number of Subjects With Postoperative Sepsis | We will be assessing for a number of patients with post-operative infection that requires intravenous antibiotics | trial was terminated before the outcome measure data were collected | Posted | Through hospital discharge, approximately three days |
|
|
| Secondary | Number of Acute Rejection of Renal Transplant | Occurs when the immune system identifies a grafted organ as foreign and attacks it | trial was terminated before the outcome measure data were collected | Posted | Up to one week |
|
|
| Secondary | Number of Subjects With Local Anesthetic Systemic Toxicity (LAST) | A life-threatening adverse reaction resulting from local anesthetic reaching significant systemic circulating levels | trial was terminated before the outcome measure data were collected | Posted | Through hospital discharge, approximately four days |
|
|
| Secondary | Number of Patients Who Need Continuous Veno-venous Hemodiafiltration (CVVHDF) After Renal Transplant | Temporary treatment for patients with acute renal failure | trial was terminated before the outcome measure data were collected | Posted | By time of hospital discharge, approximately four days |
|
|
| Secondary | Number of Patients With Symptoms of Opioid Toxicity After Renal Transplant | Opioid toxicity requiring naloxone | trial was terminated before the outcome measure data were collected | Posted | Through hospital discharge, approximately four days |
|
|
| Secondary | Number of Patients With Ileus After Renal Transplant | Painful obstruction of the ileum or other part of the intestine | trial was terminated before the outcome measure data were collected | Posted | Through hospital discharge, approximately four days |
|
|
| Secondary | Total Length of Hospital Stay | Transplant time to discharge time | trial was terminated before the outcome measure data were collected | Posted | Through hospital discharge, approximately four days |
|
|
| Secondary | Length of Intensive Care Unit Stay | Number of days spent in the intensive care unit following transplant | trial was terminated before the outcome measure data were collected | Posted | Through hospital discharge, approximately four days |
|
|
| Secondary | Vital Status | Alive or dead at time of hospital discharge | trial was terminated before the outcome measure data were collected | Posted | Through hospital discharge, approximately four days |
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Transversus Abdominis Plane (TAP) Block | Transversus abdominis plane (TAP) block: 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) | 0 | 7 | 0 | 7 | 0 | 7 |
| EG002 | Quadratus Lumborum (QL) Block | Quadratus Lumborum (QL) Block: 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) | 0 | 5 | 0 | 5 | 0 | 5 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|