Postoperative Pain Control Following Renal Transplant

Phase 4

Terminated

• Conditions: Pain, Postoperative; Kidney Transplant; Complications
• Interventions: Drug: Intravenous Lidocaine; Drug: Transversus abdominis plane (TAP) block; Drug: Quadratus Lumborum (QL) Block

• Registration Number: NCT05044429
• Lead Sponsor: George Washington University

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.

Study Timeline

• Study Start: 2021-03-16
• Study First Submitted: 2021-04-13
• Study First Submitted QC: 2021-09-10
• Study First Posted: 2021-09-14
• Primary Completion: 2023-11-29
• Study Completion: 2023-11-29
• Results First Submitted: 2024-02-08
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-15
• Last Update Submitted: 2024-03-15
• Results First Posted: 2024-03-18
• Last Update Posted: 2024-03-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Unilateral renal transplant

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous Lidocaine	Intravenous Lidocaine	-
Transversus abdominis plane (TAP) block	Transversus abdominis plane (TAP) block	-
Quadratus Lumborum (QL) Block	Quadratus Lumborum (QL) Block	-

Primary Outcome Measures

Name	Time	Method
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
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
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
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

Secondary Outcome Measures

Name	Time	Method
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 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
Vital Status	Through hospital discharge, approximately four days	Alive or dead at time of hospital discharge
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 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
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

Trial Locations

Locations (1)

George Washington University Hospital; 🇺🇸 Washington, District of Columbia, United States