NCT05044429

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2021

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2021

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 14, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2023

Completed
4 months until next milestone

Results Posted

Study results publicly available

March 18, 2024

Completed
Last Updated

March 18, 2024

Status Verified

March 1, 2024

Enrollment Period

2.7 years

First QC Date

April 13, 2021

Results QC Date

February 8, 2024

Last Update Submit

March 15, 2024

Conditions

Kidney Transplant; ComplicationsPain, Postoperative

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (9)

  • Number of Subjects With Postoperative Sepsis

    Through hospital discharge, approximately three days

  • Number of Acute Rejection of Renal Transplant

    Up to one week

  • Number of Subjects With Local Anesthetic Systemic Toxicity (LAST)

    Through hospital discharge, approximately four days

  • Number of Patients Who Need Continuous Veno-venous Hemodiafiltration (CVVHDF) After Renal Transplant

    By time of hospital discharge, approximately four days

  • Number of Patients With Symptoms of Opioid Toxicity After Renal Transplant

    Through hospital discharge, approximately four days

  • +4 more secondary outcomes

Study Arms (3)

Intravenous Lidocaine

EXPERIMENTAL
Drug: Intravenous Lidocaine

Transversus abdominis plane (TAP) block

ACTIVE COMPARATOR
Drug: Transversus abdominis plane (TAP) block

Quadratus Lumborum (QL) Block

ACTIVE COMPARATOR
Drug: Quadratus Lumborum (QL) Block

Interventions

Intravenous LidocaineDRUG

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)

Intravenous Lidocaine
Transversus abdominis plane (TAP) blockDRUG

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)

Transversus abdominis plane (TAP) block
Quadratus Lumborum (QL) BlockDRUG

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)

Quadratus Lumborum (QL) Block

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral renal transplant

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States

Location

Related Publications (3)

  • 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.

    PMID: 24898186BACKGROUND

  • 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.

    PMID: 30117019BACKGROUND

  • 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.

    PMID: 31341831BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Results Point of Contact

Title
Principal Investigator
Organization
GWUniversity
eheinz@mfa.gwu.edu
202-823-4259

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anesthesiology and Critical Care

Study Record Dates

First Submitted

April 13, 2021

First Posted

September 14, 2021

Study Start

March 16, 2021

Primary Completion

November 29, 2023

Study Completion

November 29, 2023

Last Updated

March 18, 2024

Results First Posted

March 18, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)