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ESPB with Ropivacaine for Incision Site Pain

Phase 4
Waitlist Available
Led By Alireza Aminsharifi, M.D.
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Planned to be hospitalized for at least 24 hours post-op
American Society of Anesthesiologists (ASA) Physical Status classification I to III
Must not have
Patients with allergies to local anesthetics or opiates (hydromorphone or oxycodone)
Patient refusal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 14 days postoperatively.
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
All Individual Drugs Already Approved
Approved for 5 Other Conditions

Summary

This trial will compare the use of ESPB to IV and oral opiates in managing pain for those undergoing surgery through a flank incision.

Who is the study for?
This trial is for consenting adults aged 18-85 with an ASA Physical Status classification I to III, who can stay in the hospital for at least a day after surgery and use a pain scale. It's not for those with chronic pain or on long-term neurologic meds, having multiple surgeries, allergic to local anesthetics/opiates, or with scoliosis.
What is being tested?
The study tests if Erector Spinae Plane block (ESPB) using Ropivacaine is better than standard IV and oral opiates for managing post-op pain in patients undergoing flank or anterior subcostal incisions. Participants are randomly assigned to receive either ESPB or saline as control.
What are the potential side effects?
Ropivacaine may cause side effects like low blood pressure, nausea, vomiting, dizziness, numbness around the injection site. Normal saline has minimal risk but might cause irritation at the infusion site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I will be in the hospital for at least a day after my surgery.
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My health is good to moderately impaired according to the ASA classification.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am allergic to certain pain medications or local anesthetics.
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I have chosen not to participate in certain treatments or procedures.
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I am not planning any other surgeries that require cuts on my body.
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I have been on pain or neurological medication for more than 3 months or use a neuromodulator.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 14 days postoperatively.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through 14 days postoperatively. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain scores using the Visual Analogue Pain Scale from zero pain to level ten pain
Secondary study objectives
Patient Satisfaction Survey of Pain Control Over Time
Other study objectives
Total amount of opiates

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RopivicaineExperimental Treatment1 Intervention
Erector Spinae Block of 20ml 0.5% ropivicaine bolus, connected to a pump containing 0.2% ropivicaine receiving 15ml every 3 hrs.
Group II: Normal SalinePlacebo Group1 Intervention
Erector Spinae Block of 20ml normal saline placebo bolus, then connected to pump of normal saline receiving 15ml every 3 hrs.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ropivacaine
FDA approved

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor
508 Previous Clinical Trials
2,796,324 Total Patients Enrolled
Alireza Aminsharifi, M.D.Principal InvestigatorMilton S. Hershey Medical Center
Sanjib Adhikary, M.D.Principal InvestigatorMilton S. Hershey Medical Center

Media Library

Erector Spinae Plane Block Clinical Trial Eligibility Overview. Trial Name: NCT03691935 — Phase 4
Nephrectomy Research Study Groups: Ropivicaine, Normal Saline
Nephrectomy Clinical Trial 2023: Erector Spinae Plane Block Highlights & Side Effects. Trial Name: NCT03691935 — Phase 4
Erector Spinae Plane Block 2023 Treatment Timeline for Medical Study. Trial Name: NCT03691935 — Phase 4
~2 spots leftby Feb 2025
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