Postoperative Pain Control Following Renal Transplant

Overview

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.

Full Title of Study: “Postoperative Pain Control With Systemic Lidocaine vs. Regional Anesthesia in Renal Transplant Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 16, 2024

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

  • 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)
  • 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)
  • 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)

Arms, Groups and Cohorts

  • Experimental: Intravenous Lidocaine
  • Active Comparator: Transversus abdominis plane (TAP) block
  • Active Comparator: Quadratus Lumborum (QL) Block

Clinical Trial Outcome Measures

Primary Measures

  • Opioid utilization (12 hour post-operative)
    • Time Frame: 12 hours after surgery
    • Measured in oral morphine equivalents
  • Opioid utilization (24 hour post-operative)
    • Time Frame: 24 hours after surgery
    • Measured in oral morphine equivalents
  • Opioid utilization (36 hour post-operative)
    • Time Frame: 36 hours after surgery
    • Measured in oral morphine equivalents
  • Opioid utilization (48 hour post-operative)
    • Time Frame: 48 hours after surgery
    • Measured in oral morphine equivalents
  • Pain level (12 hour post-operative)
    • Time Frame: 12 hours after surgery
    • Measured using visual analog scale (0-10), 0 is the best and 10 is the worst
  • Pain level (24 hour post-operative)
    • Time Frame: 24 hours after surgery
    • Measured using visual analog scale (0-10), 0 is the best and 10 is the worst
  • Pain level (36 hour post-operative)
    • Time Frame: 36 hours after surgery
    • Measured using visual analog scale (0-10), 0 is the best and 10 is the worst
  • Pain level (48 hour post-operative)
    • Time Frame: 48 hours after surgery
    • Measured using visual analog scale (0-10), 0 is the best and 10 is the worst

Secondary Measures

  • Sepsis
    • Time Frame: Through hospital discharge, approximately three days
    • Post-operative infection that requires intravenous antibiotics
  • Acute rejection of transplant
    • Time Frame: Up to one week
    • Occurs when the immune system identifies a grafted organ as foreign and attacks it
  • Local Anesthetic Systemic Toxicity (LAST)
    • Time Frame: Through hospital discharge, approximately four days
    • A life-threatening adverse reaction resulting from local anesthetic reaching significant systemic circulating levels
  • Continuous veno-venous hemodiafiltration (CVVHDF)
    • Time Frame: By time of hospital discharge, approximately four days
    • Temporary treatment for patients with acute renal failure
  • Opioid toxicity
    • Time Frame: Through hospital discharge, approximately four days
    • Opioid toxicity requiring naloxone
  • Ileus
    • Time Frame: Through hospital discharge, approximately four days
    • Painful obstruction of the ileum or other part of the intestine
  • Total length of hospital stay
    • Time Frame: Through hospital discharge, approximately four days
    • Transplant time to discharge time
  • Length of intensive care unit stay
    • Time Frame: Through hospital discharge, approximately four days
    • Number of days spent in the intensive care unit following transplant
  • Vital status
    • Time Frame: Through hospital discharge, approximately four days
    • Alive or dead at time of hospital discharge

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • George Washington University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Marian Sherman, Associate Professor of Anesthesiology and Critical Care – George Washington University
  • Overall Contact(s)
    • Marian Sherman, MD, (202) 741-2733, msherman@mfa.gwu.edu

References

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.

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. Review.

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.

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