0.2% ropivacaine local anesthetic continuous erector spinae plane block for Acute Pain

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
University of California, San Diego, San Diego, CA
Acute Pain+3 More
0.2% ropivacaine local anesthetic continuous erector spinae plane block - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a catheter placed in the back may help reduce pain following surgery.

See full description

Eligible Conditions

  • Acute Pain
  • Anesthesia, Local
  • Hepatic Resection
  • Anaesthesia therapy

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

This trial is evaluating whether 0.2% ropivacaine local anesthetic continuous erector spinae plane block will improve 1 primary outcome and 7 secondary outcomes in patients with Acute Pain. Measurement will happen over the course of Total number of days requiring hospitalization for surgical procedure. Up to 1 month..

Day 0
Nausea
Time to ambulation
Time to oral intake
Day 0
Pain Score at rest and with cough
Month 1
Hospital Length Of Stay
Day 4
Total opioid requirement postoperative day (POD) 0-4
Day 3
Total opioid requirement postoperative day (POD) 1-3
Day 30
Discharge opioids and refills.

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Active Treatment
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 70 total participants across 2 different treatment groups

This trial involves 2 different treatments. 0.2% Ropivacaine Local Anesthetic Continuous Erector Spinae Plane Block is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Active TreatmentThis group will receive a continuous erector spinae block catheter followed by an infusion of ropivacaine 0.2% at 10ml automatic set bolus per 120 minutes with 2ml/hr continuous infusion (14mls total every 2 hours per catheter)
PlaceboThis group will receive a superficially placed (taped to the surface) erector spinae block catheter with a ropivacaine 0.2% infusion at 0.1ml /hr

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: post-operative day 0, 1, 2, 3, 4, 14, 30
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly post-operative day 0, 1, 2, 3, 4, 14, 30 for reporting.

Who is running the study

Principal Investigator
E. T. S.
Prof. Engy T. Said, MD
University of California, San Diego

Closest Location

University of California, San Diego - San Diego, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
undergoing hepatic resection
Admitting service requests APS consult
>18 years old and able to provide consent

Patient Q&A Section

Has 0.2% ropivacaine local anesthetic continuous erector spinae plane block proven to be more effective than a placebo?

"A 0.2% local anesthetic and epinephrine continuous erector spinae plane block in routine practice in the outpatient setting provided similar short-term pain relief and quicker recovery compared with a placebo in a selected group of women with chronic nonspecific low back pain." - Anonymous Online Contributor

Unverified Answer

What causes acute pain?

"Non-cancer pain is a complex and variable problem. Although it is still not fully understood, there is a strong link between psychological factors and pain perception and pain expression. It is often difficult to identify and interpret causes of pain, particularly in those with psychiatric illness." - Anonymous Online Contributor

Unverified Answer

Can acute pain be cured?

"Almost one third of all patients in this study obtained good to fair pain relief with the use of opioids, either as adjunctive or monotherapy. Although this level is obviously low, we conclude that acute pain can be greatly ameliorated in some patients with a reasonable chance of recurrence." - Anonymous Online Contributor

Unverified Answer

What are the signs of acute pain?

"Clinical signs of acute pain are variable. Simple signs of a painful condition may be observed, but they may be lacking. An accurate clinical history is the best indicator of the condition." - Anonymous Online Contributor

Unverified Answer

What is acute pain?

"In acute pain, pain is often described as "jumping electric impulses through your body." Pain can cause anxiety, fear, and disruption in daily activities. It can cause feelings of powerlessness, helplessness, guilt, and shame, as well as a sense of dread. Acute pain is a type of pain that needs immediate treatment (e.g., with a narcotic such as morphine).\n" - Anonymous Online Contributor

Unverified Answer

What are common treatments for acute pain?

"Common treatments for acute pain are analgesics (including nonsteroidal anti-inflammatories), oral painkillers (including paracetamol and NSAIDs), muscle relaxants, antiemetics and sedatives. Of note, the nonopioid analgesics have been superseded by more versatile agents such as opioid-based medicines." - Anonymous Online Contributor

Unverified Answer

How many people get acute pain a year in the United States?

"About 25 million people in the United States are treated for acute pain a year. Acute pain affects about six million people every year. Acute pain is the second most important source of pain-related healthcare use after cancer. Improved and better documentation of clinical care is desirable in treating acute pain." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating acute pain?

"Although the research on acute pain is not new, the literature for current pharmacological treatments of acute pain is still large. Most currently accepted medications for chronic pain were developed for other uses before they were shown to be effective for acute pain. Pharmacological medications and surgical procedures, however, can potentially be used to decrease acute pain." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of 0.2% ropivacaine local anesthetic continuous erector spinae plane block?

"We have reported a high frequency of postoperative residual shivering after 0.2% ropivacaine continuous epidural analgesia in children. Therefore, meticulous attention is required in patients who have spinal surgery." - Anonymous Online Contributor

Unverified Answer

Is 0.2% ropivacaine local anesthetic continuous erector spinae plane block safe for people?

"This is the largest case series of continuous-infusion ropivacaine used in a single, continuous-infusion site during a single, painful procedure with no adverse events, complications, hemodynamic changes, or serious drug-related events. We concluded that use of 0.2% ropivacaine during a continuous-infusion erector spinae regional block in adults is safe. Future studies should evaluate longer durations of ropivacaine infusions." - Anonymous Online Contributor

Unverified Answer

How does 0.2% ropivacaine local anesthetic continuous erector spinae plane block work?

"Continuous epidural 0.20% ropivacaine is well acceptable with excellent postoperative analgesia and a small incidence of side effects. The benefit/toxicity ratio for epidural 0.20% ropivacaine is better compared to conventional lidocaine." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving 0.2% ropivacaine local anesthetic continuous erector spinae plane block?

"To our knowledge, the present report was the first to evaluate the efficacy of the 0.2% ropivacaine continuous erector spinae plane block. Findings from a recent study of this study reveal that this local anesthetic is effective and well tolerated with a rapid onset of action, leading to reduction of pain with good patient comfort; thus presenting it as a simple and easily accessible option for the treatment of acute lower-back pain and associated sciatica syndrome." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Acute Pain by sharing your contact details with the study coordinator.