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Postoperative Pain Control Following Renal Transplant

Primary Purpose

Kidney Transplant; Complications, Pain, Postoperative

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Intravenous Lidocaine
Transversus abdominis plane (TAP) block
Quadratus Lumborum (QL) Block
Sponsored by
George Washington University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Kidney Transplant; Complications

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • George Washington University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Intravenous Lidocaine

Transversus abdominis plane (TAP) block

Quadratus Lumborum (QL) Block

Arm Description

Outcomes

Primary Outcome Measures

Opioid utilization (12 hour post-operative)
We are measuring oral morphine equivalents to assess for study intervention efficacy at 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
Opioid utilization (36 hour post-operative)
We are measuring oral morphine equivalents to assess for study intervention efficacy at 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
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
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
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
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

Secondary Outcome Measures

Number of subjects with postoperative sepsis
We will be assessing for a number of patients with post-operative infection that requires intravenous antibiotics
Number of acute rejection of renal transplant
Occurs when the immune system identifies a grafted organ as foreign and attacks it
Number of subjects with Local Anesthetic Systemic Toxicity (LAST)
A life-threatening adverse reaction resulting from local anesthetic reaching significant systemic circulating levels
Number of patients who need continuous veno-venous hemodiafiltration (CVVHDF) after renal transplant
Temporary treatment for patients with acute renal failure
Number of patients with symptoms of opioid toxicity after renal transplant
Opioid toxicity requiring naloxone
Number of patients with ileus after renal transplant
Painful obstruction of the ileum or other part of the intestine
Total length of hospital stay
Transplant time to discharge time
Length of intensive care unit stay
Number of days spent in the intensive care unit following transplant
Vital status
Alive or dead at time of hospital discharge

Full Information

First Posted
April 13, 2021
Last Updated
November 4, 2022
Sponsor
George Washington University
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1. Study Identification

Unique Protocol Identification Number
NCT05044429
Brief Title
Postoperative Pain Control Following Renal Transplant
Official Title
Postoperative Pain Control With Systemic Lidocaine vs. Regional Anesthesia in Renal Transplant Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2021 (Actual)
Primary Completion Date
March 16, 2024 (Anticipated)
Study Completion Date
March 16, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
George Washington University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplant; Complications, Pain, Postoperative

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intravenous Lidocaine
Arm Type
Experimental
Arm Title
Transversus abdominis plane (TAP) block
Arm Type
Active Comparator
Arm Title
Quadratus Lumborum (QL) Block
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Intravenous Lidocaine
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Transversus abdominis plane (TAP) block
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Quadratus Lumborum (QL) Block
Intervention Description
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)
Primary Outcome Measure Information:
Title
Opioid utilization (12 hour post-operative)
Description
We are measuring oral morphine equivalents to assess for study intervention efficacy at 12 hours after surgery
Time Frame
12 hours after surgery
Title
Opioid utilization (24 hour post-operative)
Description
We are measuring oral morphine equivalents to assess for study intervention efficacy at 24 hours after surgery
Time Frame
24 hours after surgery
Title
Opioid utilization (36 hour post-operative)
Description
We are measuring oral morphine equivalents to assess for study intervention efficacy at 36 hours after surgery
Time Frame
36 hours after surgery
Title
Opioid utilization (48 hour post-operative)
Description
We are measuring oral morphine equivalents to assess for study intervention efficacy at 48 hours after surgery
Time Frame
48 hours after surgery
Title
Pain level (12 hour post-operative)
Description
Measured using visual analog scale (0-10), 0 is the best and 10 is the worst score at 12 hours after surgery
Time Frame
12 hours after surgery
Title
Pain level (24 hour post-operative)
Description
Measured using visual analog scale (0-10), 0 is the best and 10 is the worst score at 24 hours after surgery
Time Frame
24 hours after surgery
Title
Pain level (36 hour post-operative)
Description
Measured using visual analog scale (0-10), 0 is the best and 10 is the worst score at 36 hours after surgery
Time Frame
36 hours after surgery
Title
Pain level (48 hour post-operative)
Description
Measured using visual analog scale (0-10), 0 is the best and 10 is the worst score at 48 hours after surgery
Time Frame
48 hours after surgery
Secondary Outcome Measure Information:
Title
Number of subjects with postoperative sepsis
Description
We will be assessing for a number of patients with post-operative infection that requires intravenous antibiotics
Time Frame
Through hospital discharge, approximately three days
Title
Number of acute rejection of renal transplant
Description
Occurs when the immune system identifies a grafted organ as foreign and attacks it
Time Frame
Up to one week
Title
Number of subjects with Local Anesthetic Systemic Toxicity (LAST)
Description
A life-threatening adverse reaction resulting from local anesthetic reaching significant systemic circulating levels
Time Frame
Through hospital discharge, approximately four days
Title
Number of patients who need continuous veno-venous hemodiafiltration (CVVHDF) after renal transplant
Description
Temporary treatment for patients with acute renal failure
Time Frame
By time of hospital discharge, approximately four days
Title
Number of patients with symptoms of opioid toxicity after renal transplant
Description
Opioid toxicity requiring naloxone
Time Frame
Through hospital discharge, approximately four days
Title
Number of patients with ileus after renal transplant
Description
Painful obstruction of the ileum or other part of the intestine
Time Frame
Through hospital discharge, approximately four days
Title
Total length of hospital stay
Description
Transplant time to discharge time
Time Frame
Through hospital discharge, approximately four days
Title
Length of intensive care unit stay
Description
Number of days spent in the intensive care unit following transplant
Time Frame
Through hospital discharge, approximately four days
Title
Vital status
Description
Alive or dead at time of hospital discharge
Time Frame
Through hospital discharge, approximately four days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Heinz, MD
Phone
(202) 741-2733
Email
eheinz@mfa.gwu.edu
Facility Information:
Facility Name
George Washington University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Heinz
Email
eheinz@mfa.gwu.edu
First Name & Middle Initial & Last Name & Degree
Eduard Shaykhinurov
Phone
2028234259
Email
eshaykhinurov@mfa.gwu.edu
First Name & Middle Initial & Last Name & Degree
Eric Heinz, MD
First Name & Middle Initial & Last Name & Degree
Keith Melancon, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24898186
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.
Results Reference
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PubMed Identifier
30117019
Citation
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.
Results Reference
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PubMed Identifier
31341831
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.
Results Reference
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Postoperative Pain Control Following Renal Transplant

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