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Pain Control Methods for Post-Kidney Transplant Surgery

Phase 4

Waitlist Available

Research Sponsored by George Washington University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Unilateral renal transplant

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through hospital discharge, approximately four days

Awards & highlights

Study Summary

This trial will compare two methods of controlling pain after kidney transplant surgery - a regional anesthetic block and an IV infusion of lidocaine.

Who is the study for?

This trial is for individuals undergoing unilateral kidney transplant surgery, without chronic pain or opioid use disorders. Participants should not have heart rhythm problems, heart failure, severe liver issues, allergies to local anesthetics like lidocaine and ropivacaine, or complications during surgery.Check my eligibility

What is being tested?

The study compares two methods of controlling post-surgery pain in kidney transplant patients: regional anesthetic blocks (QL and TAP block) versus systemic IV lidocaine. It's a prospective randomized trial that assesses which method works better alongside standard PCA pumps.See study design

What are the potential side effects?

Potential side effects may include discomfort at the injection site for blocks or mild reactions to IV lidocaine such as dizziness, sleepiness, changes in blood pressure or abnormal sensations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had a kidney transplant on one side.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through hospital discharge, approximately four days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through hospital discharge, approximately four days

This trial's timeline: 3 weeks for screening, Varies for treatment, and through hospital discharge, approximately four days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Opioid Utilization (12 Hour Post-operative)

Opioid Utilization (24 Hour Post-operative)

Opioid Utilization (36 Hour Post-operative)

+5 more

Secondary outcome measures

Length of Intensive Care Unit Stay

Number of Acute Rejection of Renal Transplant

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

+6 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Intravenous LidocaineExperimental Treatment1 Intervention

Group II: Quadratus Lumborum (QL) BlockActive Control1 Intervention

Group III: Transversus abdominis plane (TAP) blockActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lidocaine

FDA approved

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

George Washington UniversityLead Sponsor

243 Previous Clinical Trials

453,743 Total Patients Enrolled

Media Library

Intravenous Lidocaine Clinical Trial Eligibility Overview. Trial Name: NCT05044429 — Phase 4

Postoperative Pain Research Study Groups: Quadratus Lumborum (QL) Block, Transversus abdominis plane (TAP) block, Intravenous Lidocaine

Postoperative Pain Clinical Trial 2023: Intravenous Lidocaine Highlights & Side Effects. Trial Name: NCT05044429 — Phase 4

Intravenous Lidocaine 2023 Treatment Timeline for Medical Study. Trial Name: NCT05044429 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what degree is Intravenous Lidocaine risky for patients?

"The safety of Intravenous Lidocaine is highly rated at a 3, since this treatment has entered its fourth phase of clinical trials and gained approval."

Answered by AI

Is the eligibility criteria for this medical trial limited to those under 20 years of age?

"According to the inclusion criteria, this clinical trial is suitable for people from 18-99 years of age. Meanwhile, there are 81 studies involving minors and 504 trials dedicated to seniors."

Answered by AI

What is the maximum capacity of participants for this trial?

"Yes, clinicaltrials.gov confirms that recruitment is still in progress for this study which was launched on March 16th 2021. The trial needs to enrol 100 patients from a single site and the information has recently been updated on November 4th 2022."

Answered by AI

Are there records of any past experiments involving Intravenous Lidocaine?

"Currently, there are 118 investigations into Intravenous Lidocaine. Of those studies, 31 have reached Phase 3 clinical trial status. While a majority of the research is located in Calgary, Alberta - 1094 sites across North America are conducting trials for this treatment option."

Answered by AI

What purpose does this investigation seek to accomplish?

"This clinical trial's primary objective is to quantify the opioid utilization within a 48-hour window post-surgery. Secondary measures of success include observing acute rejection rates, symptoms of opioid toxicity necessitating naloxone treatment, and incidences of Local Anesthetic Systemic Toxicity (LAST)."

Answered by AI

Are there any open enrolment opportunities for this research project?

"Affirmative. Clinicaltrials.gov indicates that this study is currently in search of participants, with the first posting on March 16th 2021 and last update being November 4th 2022. This trial needs to enrol 100 individuals from a single site."

Answered by AI

Are there any restrictions on who can participate in this experiment?

"To meet the eligibility criteria for this trial, volunteers must be aged 18-99 and suffer from postoperative pain. A total of 100 individuals will be recruited to participate in the study."

Answered by AI