Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05044429
Other study ID # NCR202221
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date March 16, 2021
Est. completion date November 29, 2023

Study information

Verified date March 2024
Source George Washington University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 31
Est. completion date November 29, 2023
Est. primary completion date November 29, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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)
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)
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)

Locations

Country Name City State
United States George Washington University Hospital Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
George Washington University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
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 12 hours after surgery
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 24 hours after surgery
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 36 hours after surgery
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 48 hours after surgery
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Number of Patients With Symptoms of Opioid Toxicity After Renal Transplant Opioid toxicity requiring naloxone Through hospital discharge, approximately four days
Secondary 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
Secondary Total Length of Hospital Stay Transplant time to discharge time Through hospital discharge, approximately four days
Secondary Length of Intensive Care Unit Stay Number of days spent in the intensive care unit following transplant Through hospital discharge, approximately four days
Secondary Vital Status Alive or dead at time of hospital discharge Through hospital discharge, approximately four days
See also
  Status Clinical Trial Phase
Completed NCT05480111 - The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy Phase 4
Completed NCT06129305 - Erector Spina Muscle Distance From the Skin at Different Thoracal Elevations
Completed NCT04401826 - Micro-surgical Treatment of Gummy Smile N/A
Recruiting NCT04020133 - the Role of Popliteal Plexus Block in Pain Management After Anterior Cruciate Ligament Reconstruction. N/A
Completed NCT03023462 - Efficacy of an Anterior Quadratus Lumborum Block vs. a TAP-block for Inguinal Hernia Repair N/A
Completed NCT03652103 - Efficiency of Erector Spinae Plane Block For Patients Undergoing Percutaneous Nephrolithotomy Phase 4
Completed NCT03546738 - Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery N/A
Withdrawn NCT03528343 - Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy Phase 1/Phase 2
Terminated NCT03261193 - ITM + Bupivacaine QLB vs. ITM + Sham Saline QLB for Cesarean Delivery Pain Phase 3
Completed NCT02525133 - Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty Phase 3
Completed NCT03244540 - Regional Analgesia After Cesarean Section Phase 4
Enrolling by invitation NCT05316168 - Post Operative Pain Management for ACL Reconstruction Phase 3
Recruiting NCT04130464 - Intraperitoneal Infusion of Analgesic for Postoperative Pain Management Phase 4
Enrolling by invitation NCT04574791 - Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee Arthroplasty N/A
Completed NCT04073069 - Scalp Infiltration With Diprospan Plus Ropivacaine for Postoperative Pain After Craniotomy in Adults Phase 4
Completed NCT04526236 - Influence of Aging on Perioperative Methadone Dosing Phase 4
Recruiting NCT05351229 - Intrathecal Morphine for Analgesia in Video-assisted Thoracic Surgery Phase 4
Enrolling by invitation NCT05543109 - Ultrasound Guided Psoas Compartment Block vs Suprainguinal Fascia Iliaca Compartment Block N/A
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Completed NCT04919317 - Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty Phase 2