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Pain Management After VATS for Postoperative Pain

Phase 2
Recruiting
Led By Yatish Ranganath, MD
Research Sponsored by YATISH SIDDAPURA RANGANATH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age over 18 years and less than 80 years
Undergoing video-assisted thoracoscopic surgery (VATS) procedure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months post procedure.
Awards & highlights

Study Summary

This trial is looking for the best way to manage pain after VATS surgery, which is a minimally-invasive surgery for lung conditions.

Who is the study for?
This trial is for adults aged 18-80 undergoing VATS who are not pregnant, have a BMI under 40, and can consent. It excludes those with chronic pain conditions, opioid tolerance, allergies to study drugs, infectious diseases, coagulation issues, severe liver disease or incarceration.Check my eligibility
What is being tested?
The study tests two types of pain management medications after VATS: Bupivacaine and Liposomal bupivacaine. The aim is to determine which provides better post-surgical pain relief without causing respiratory problems.See study design
What are the potential side effects?
Possible side effects include nausea, vomiting, constipation from the opioids typically used for surgery-related pain; local reactions at the injection site; and rare but serious side effects like nerve damage or heart complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 79 years old.
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I am scheduled for a minimally invasive chest surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months post procedure.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months post procedure. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Measure post-operative acute pain scores
Measure post-operative opioid usage
Secondary outcome measures
Calculate length of hospital stay
Measure lung function
Measure post-operative opioid consumption following discharge from the hospital
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Liposomal bupivacaineExperimental Treatment1 Intervention
The patient will receive an intercostal nerve block by the surgeon in the operating room after anesthetic has been administered. The surgeon will use thoracoscopic guidance to administer the intercostal nerve block. The medication used in this block will liposomal bupivacaine (Exparel).
Group II: BupivacaineActive Control1 Intervention
The patient will receive a paravertebral block by the anesthesiologist staffing the pain service area within the hospital prior to surgery. This regional anesthesia will be done using ultrasound guidance. The medication used in this block will be plain bupivacaine with epinephrine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine
FDA approved

Find a Location

Who is running the clinical trial?

YATISH SIDDAPURA RANGANATHLead Sponsor
1 Previous Clinical Trials
120 Total Patients Enrolled
Rakesh Sondekoppam VijayashankarLead Sponsor
1 Previous Clinical Trials
140 Total Patients Enrolled
American Society of Regional AnesthesiaOTHER
4 Previous Clinical Trials
135 Total Patients Enrolled

Media Library

Liposomal bupivacaine Clinical Trial Eligibility Overview. Trial Name: NCT04864210 — Phase 2
Postoperative Pain Research Study Groups: Liposomal bupivacaine, Bupivacaine
Postoperative Pain Clinical Trial 2023: Liposomal bupivacaine Highlights & Side Effects. Trial Name: NCT04864210 — Phase 2
Liposomal bupivacaine 2023 Treatment Timeline for Medical Study. Trial Name: NCT04864210 — Phase 2

Frequently Asked Questions

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

Is the current research project open to enrollment of individuals over 55 years old?

"The participant requirements for this trial necessitate that patients must be over 18 yet under 80 years of age."

Answered by AI

How many participants are currently participating in this clinical trial?

"Affirmative, according to clinicaltrials.gov this medical study is currently recruiting participants. It was initially posted on February 2nd 2021 and recently updated on September 19th 2022, with a total of 128 patients being sought from one single site."

Answered by AI

What aims is this medical experiment hoping to achieve?

"The primary outcome of this research is to assess post-operative acute pain scores up to 72 hours after the procedure. Secondary objectives include measuring lung function using an incentive spirometer device, tracking opioid consumption following hospital discharge, and determining total length of hospital stay. The air volume inhaled will be graded on a scale from 0 - 2500 milliliters with higher values indicating greater respiratory function compared to baseline measurements before surgery."

Answered by AI

To what extent am I eligible to join in this research experiment?

"This clinical trial is seeking 128 individuals with postoperative pain aged between 18 and 80. Notably, prospective participants must be over the age of consent, possess a body mass index below 40, and undergo video-assisted thoracoscopic surgery (VATS)."

Answered by AI

Have any other studies been conducted involving Liposomal bupivacaine?

"Currently, 108 studies are evaluating the efficacy of Liposomal bupivacaine. 18 trials have reached Phase 3 status and they are being conducted in 143 locations primarily based around Philadelphia, Pennsylvania."

Answered by AI

Has the Federal Drug Administration given their stamp of approval to Liposomal bupivacaine?

"Liposomal bupivacaine is rated a 2 on the safety scale, as clinical data supports its safety but there is no evidence of efficacy yet."

Answered by AI

Are there any available vacancies for potential participants in this experiment?

"That is correct. According to clinicaltrials.gov, this medical trial has been recruiting patients since February 2nd 2021 and the listing was recently updated on September 19th 2022. 128 participants are being sought from a single site for this experiment."

Answered by AI

For what conditions has Liposomal bupivacaine been prescribed?

"Liposomal bupivacaine is a commonly-prescribed treatment for permphigus, as well as acute nonspecific tenosynovitis, general anesthesia, and lupus erythematosus cell."

Answered by AI
Recent research and studies
~22 spots leftby Dec 2024