Kidney Transplant; Complications, Pain, Postoperative
Conditions
Brief 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. 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.
Interventions
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)
DRUGTransversus 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)
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)
Sponsors
George Washington University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Unilateral renal transplant
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Utilization (12 Hour Post-operative) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Postoperative Sepsis | Through hospital discharge, approximately three days | We will be assessing for a number of patients with post-operative infection that requires intravenous antibiotics |
| Vital Status | Through hospital discharge, approximately four days | Alive or dead at time of hospital discharge |
| Number of Acute Rejection of Renal Transplant | Up to one week | Occurs when the immune system identifies a grafted organ as foreign and attacks it |
| Number of Subjects With Local Anesthetic Systemic Toxicity (LAST) | Through hospital discharge, approximately four days | A life-threatening adverse reaction resulting from local anesthetic reaching significant systemic circulating levels |
| Number of Patients Who Need Continuous Veno-venous Hemodiafiltration (CVVHDF) After Renal Transplant | By time of hospital discharge, approximately four days | Temporary treatment for patients with acute renal failure |
| Number of Patients With Symptoms of Opioid Toxicity After Renal Transplant | Through hospital discharge, approximately four days | Opioid toxicity requiring naloxone |
| Number of Patients With Ileus After Renal Transplant | Through hospital discharge, approximately four days | Painful obstruction of the ileum or other part of the intestine |
| Total Length of Hospital Stay | Through hospital discharge, approximately four days | Transplant time to discharge time |
| Length of Intensive Care Unit Stay | Through hospital discharge, approximately four days | Number of days spent in the intensive care unit following transplant |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 19 |
| 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) | 7 |
| 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) | 5 |
| Total | 31 |
Baseline characteristics
| Characteristic | Intravenous Lidocaine | Transversus Abdominis Plane (TAP) Block | Quadratus Lumborum (QL) Block | Total | — |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 0 Participants | 2 Participants | — |
| Age, Categorical Between 18 and 65 years | 18 Participants | 6 Participants | 5 Participants | 29 Participants | — |
| Age, Continuous | 49.1 years | 49.8 years | 52.2 years | 49.8 years | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 2 Participants | 0 Participants | 5 Participants | — |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 4 Participants | 5 Participants | 25 Participants | — |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants | — |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants | — |
| Race (NIH/OMB) Black or African American | 16 Participants | 3 Participants | 5 Participants | 24 Participants | — |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 0 Participants | 4 Participants | — |
| Race (NIH/OMB) White | 0 Participants | 2 Participants | 0 Participants | 2 Participants | — |
| Region of Enrollment United States | — | — | — | — | — participants |
| Sex: Female, Male Female | 10 Participants | 4 Participants | 1 Participants | 15 Participants | — |
| Sex: Female, Male Male | 9 Participants | 3 Participants | 4 Participants | 16 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 7 | 0 / 5 |
| other Total, other adverse events | 0 / 19 | 0 / 7 | 0 / 5 |
| serious Total, serious adverse events | 0 / 19 | 0 / 7 | 0 / 5 |
Outcome results
Primary
Opioid Utilization (12 Hour Post-operative)
We are measuring oral morphine equivalents to assess for study intervention efficacy at 12 hours after surgery
Time frame: 12 hours after surgery
Population: trial was terminated before the outcome measure data were collected
Primary
Opioid Utilization (24 Hour Post-operative)
We are measuring oral morphine equivalents to assess for study intervention efficacy at 24 hours after surgery
Time frame: 24 hours after surgery
Population: trial was terminated before the outcome measure data were collected
Primary
Opioid Utilization (36 Hour Post-operative)
We are measuring oral morphine equivalents to assess for study intervention efficacy at 36 hours after surgery
Time frame: 36 hours after surgery
Population: trial was terminated before the outcome measure data were collected
Primary
Opioid Utilization (48 Hour Post-operative)
We are measuring oral morphine equivalents to assess for study intervention efficacy at 48 hours after surgery
Time frame: 48 hours after surgery
Population: trial was terminated before the outcome measure data were collected
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
Time frame: 12 hours after surgery
Population: trial was terminated before the outcome measure data were collected
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
Time frame: 24 hours after surgery
Population: trial was terminated before the outcome measure data were collected
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
Time frame: 36 hours after surgery
Population: trial was terminated before the outcome measure data were collected
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
Time frame: 48 hours after surgery
Population: trial was terminated before the outcome measure data were collected
Secondary
Length of Intensive Care Unit Stay
Number of days spent in the intensive care unit following transplant
Time frame: Through hospital discharge, approximately four days
Population: trial was terminated before the outcome measure data were collected
Secondary
Number of Acute Rejection of Renal Transplant
Occurs when the immune system identifies a grafted organ as foreign and attacks it
Time frame: Up to one week
Population: trial was terminated before the outcome measure data were collected
Secondary
Number of Patients Who Need Continuous Veno-venous Hemodiafiltration (CVVHDF) After Renal Transplant
Temporary treatment for patients with acute renal failure
Time frame: By time of hospital discharge, approximately four days
Population: trial was terminated before the outcome measure data were collected
Secondary
Number of Patients With Ileus After Renal Transplant
Painful obstruction of the ileum or other part of the intestine
Time frame: Through hospital discharge, approximately four days
Population: trial was terminated before the outcome measure data were collected
Secondary
Number of Patients With Symptoms of Opioid Toxicity After Renal Transplant
Opioid toxicity requiring naloxone
Time frame: Through hospital discharge, approximately four days
Population: trial was terminated before the outcome measure data were collected
Secondary
Number of Subjects With Local Anesthetic Systemic Toxicity (LAST)
A life-threatening adverse reaction resulting from local anesthetic reaching significant systemic circulating levels
Time frame: Through hospital discharge, approximately four days
Population: trial was terminated before the outcome measure data were collected
Secondary
Number of Subjects With Postoperative Sepsis
We will be assessing for a number of patients with post-operative infection that requires intravenous antibiotics
Time frame: Through hospital discharge, approximately three days
Population: trial was terminated before the outcome measure data were collected
Secondary
Total Length of Hospital Stay
Transplant time to discharge time
Time frame: Through hospital discharge, approximately four days
Population: trial was terminated before the outcome measure data were collected
Secondary
Vital Status
Alive or dead at time of hospital discharge
Time frame: Through hospital discharge, approximately four days
Population: trial was terminated before the outcome measure data were collected