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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

Must not have

Severe hepatic disease

Patients with impaired coagulation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months post procedure.

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe liver disease.

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My blood does not clot properly.

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I have had a surgery to fuse my lung lining using a camera-assisted technique.

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I have long-term chronic pain.

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I am tolerant to opioids.

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My BMI is over 40.

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I am unable to understand or sign the consent form.

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I do not speak English.

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I have an infectious disease.

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I have chronic pain conditions like fibromyalgia or nerve pain in my chest area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months post procedure.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measure post-operative acute pain scores

Measure post-operative opioid usage

Secondary study objectives

Calculate length of hospital stay

Measure lung function

Measure post-operative opioid consumption following discharge from the hospital

+2 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 12Eligibility criteria met