Your session is about to expire
← Back to Search
IV Lidocaine for Hernia Repair (PEH Trial)
Phase 4
Recruiting
Led By Paul D Colavita, MD
Research Sponsored by Atrium Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
American Association of Anesthesiologists (ASA) scores of I-III
Undergoing elective laparoscopic paraesophageal hernia repair including robotic assisted laparoscopic cases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
PEH Trial Summary
This trial will study the effects of IV lidocaine on post-operative pain control and outcomes in patients undergoing paraesophageal hernia repair, compared to the current standard of care.
Who is the study for?
This trial is for adults over 18 undergoing elective laparoscopic paraesophageal hernia repair. Candidates must have an ASA score of I-III and not be on opioid pain medication or daily chronic pain medication. Exclusions include those with seizure disorders, certain heart conditions, severe kidney disease, recent opioid use, planned additional surgeries, extreme obesity (BMI >40), lidocaine allergies, or contraindications to sodium channel blockers.Check my eligibility
What is being tested?
The study tests if IV lidocaine improves postoperative pain control in patients having paraesophageal hernia repairs compared to a placebo. It will assess the effect on recovery outcomes like hospital stay length, complications rates, and quality of life within an Enhanced Recovery After Surgery (ERAS) protocol.See study design
What are the potential side effects?
Potential side effects from IV lidocaine may include symptoms such as dizziness, sleepiness, confusion or clear thinking problems; vision changes; ringing in the ears; numbness around the mouth; tremors; seizures if levels get too high; and allergic reactions.
PEH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My health is good to moderate, as rated by an anesthesiologist.
Select...
I am scheduled for a laparoscopic surgery to repair a hernia near my esophagus.
Select...
I am 18 years old or older.
PEH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Day to toleration of diet
Length of Stay
Post-Op Morphine Equivalents
+2 moreSide effects data
From 2019 Phase 4 trial • 86 Patients • NCT035400303%
Hospitalization for ileus
3%
mesenteric artery stenosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Non-Opioid Intervention
Observational
PEH Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: IV LidocaineExperimental Treatment1 Intervention
100 mg Lidocaine bolus on induction, then an infusion of 1.5 mg/kg/hr to begin prior to incision, run throughout the operation and continues into PACU for 1 hour OR until one 2gm/250mL D5W bag has been infused, whichever occurs first. The Patient will be monitored by nursing staff with the aid of continuous cardiac monitoring in the PACU for at least 30 minutes after the discontinuation of the lidocaine drip.
Group II: PlaceboPlacebo Group1 Intervention
Patients will receive D5W solution at the same volume and rate as the IV lidocaine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IV lidocaine
2016
Completed Phase 4
~90
Find a Location
Who is running the clinical trial?
Atrium HealthLead Sponsor
121 Previous Clinical Trials
34,804 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,242 Previous Clinical Trials
1,004,217 Total Patients Enrolled
Paul D Colavita, MDPrincipal InvestigatorWake Forest University Health Sciences
1 Previous Clinical Trials
50 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a paraesophageal hernia and meet the study's requirements.My surgery was changed to an open procedure or assisted with hands.My health is good to moderate, as rated by an anesthesiologist.I have been taking opioid pain medication or daily medication for chronic pain in the last week.I cannot take medications that block sodium channels due to health reasons.You are allergic to lidocaine or other numbing medications called amide local anesthetics.I am scheduled for a laparoscopic surgery to repair a hernia near my esophagus.I have end stage kidney disease.I am 18 years old or older.I have had surgery complications that required more treatment.I have a condition that causes seizures.I am planning to have surgery other than PEH repair.You have difficulty with movement and coordination.You have a very high body weight for your height.I have heart rhythm problems or heart failure.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: IV Lidocaine
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How is intravenous lidocaine typically applied to treat ailments?
"Intravenous lidocaine can be utilized to alleviate the symptoms of cervical syndrome, attend to minor burns, and aid in transplantation surgeries."
Answered by AI
Is enrollment in the trial currently available for participants?
"Affirmative, the study's availability is confirmed by clinicaltrials.gov. This investigation was initially posted on June 21st 2018 and received a most recent update on June 9th 2022. 50 patients are being sought after at 1 medical centre."
Answered by AI
What is the current recruitment rate for this research project?
"Affirmative. Information available on clinicaltrials.gov confirms that this experiment, which was published on June 21st 2018, is currently seeking participants. About 50 individuals will be required to take part in the study at one of its locations."
Answered by AI
Is intravenous lidocaine certified by the Food and Drug Administration?
"The safety rating for IV lidocaine is a 3, as the drug has been approved by authorities and is in Phase 4 of testing."
Answered by AI
Could you provide a comprehensive overview of previous clinical investigations related to IV lidocaine?
"At present, 31 Phase 3 trials are running for IV lidocaine and there are 118 live studies in total. Calgary is home to the majority of these clinical investigations; however, 1,094 sites worldwide have some involvement with research into this drug."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger