Postoperative Pain Control Following Renal Transplant

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05044429
• Other study ID #: NCR202221
• Status: Terminated
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Kidney Transplant; Complications
• Pain, Postoperative

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