Postoperative Pain Control Following Renal Transplant

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: George Washington University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2021
• Primary Completion (Actual): November 29, 2023
• Study Completion (Actual): November 29, 2023

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: September 10, 2021
• First Posted (Actual): September 14, 2021

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: NCR202221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes