Postoperative Pain Control Following Renal Transplant

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Postoperative Pain Control With Systemic Lidocaine vs. Regional Anesthesia in Renal Transplant Patients

Conditions
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Kidney Transplant; Complications, Pain, Postoperative

Intervention / Treatment
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* Drug: Intravenous Lidocaine
* Drug: Transversus abdominis plane (TAP) block
* Drug: Quadratus Lumborum (QL) Block


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravenous Lidocaine<br> | Drug: Intravenous Lidocaine<br>* 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)<br>|
| Active Comparator: Transversus abdominis plane (TAP) block<br> | Drug: Transversus abdominis plane (TAP) block<br>* 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)<br>|
| Active Comparator: Quadratus Lumborum (QL) Block<br> | Drug: Quadratus Lumborum (QL) Block<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |