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Local Anesthetic

Local Anesthetic Delivery Methods for Postoperative Pain

Phase 4

Waitlist Available

Led By Brian M Ilfeld, MD, MS

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients undergoing ulnar and/or radial fracture open reduction internal fixation or painful foot and/or ankle surgery with a planned infraclavicular or popliteal sciatic perineural catheter, respectively, for postoperative analgesia

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up each of 9 postoperative days

Awards & highlights

Study Summary

This trial will compare two ways of giving local anesthesia to see which results in better pain control for patients with infraclavicular and popliteal-sciatic perineural catheters.

Who is the study for?

This trial is for patients having certain arm or foot/ankle surgeries who will receive a catheter for pain relief after surgery. It's not for those who've used opioids daily in the past month, are pregnant, have nerve/muscle issues in the affected limbs, are incarcerated, had additional surgeries outside of specific areas, or are morbidly obese.Check my eligibility

What is being tested?

The study compares two ways to manage pain with ropivacaine after surgery: one group gets a steady drip through a catheter and another gets doses they can control when needed. The goal is to see which method provides better pain control and lasts longer post-discharge.See study design

What are the potential side effects?

Ropivacaine may cause side effects like numbness around the area it's given, weakness in the limb where it's applied, low blood pressure, nausea or vomiting. Rare but serious effects include seizures or heart problems if absorbed into the bloodstream.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am having surgery on my arm or leg and will get a nerve block for pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ each of 9 postoperative days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~each of 9 postoperative days

This trial's timeline: 3 weeks for screening, Varies for treatment, and each of 9 postoperative days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Average Pain queried on First postoperative day

Duration of local anesthetic administration

Secondary outcome measures

Average pain

Pain

Cumulative opioid consumption

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Titratable Automated BolusesExperimental Treatment1 Intervention

Patients will receive patient-titratable intermittent boluses of Ropivacaine 0.2% (8 mL popliteal-sciatic or 11 mL infraclavicular automated bolus every 120 minutes, 4 mL patient controlled bolus with 30-minute lockout).

Group II: Continuous InfusionActive Control1 Intervention

Patients will receive a continuous infusion of Ropivacaine 0.2% (6 mL/hr popliteal-sciatic and 8 mL/hr infraclavicular, 4 mL patient controlled bolus with 30-minute lockout).

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor

1,126 Previous Clinical Trials

1,552,851 Total Patients Enrolled

6 Trials studying Postoperative Pain

401 Patients Enrolled for Postoperative Pain

Brian M Ilfeld, MD, MSPrincipal InvestigatorUniversity of California, San Diego

19 Previous Clinical Trials

1,401 Total Patients Enrolled

1 Trials studying Postoperative Pain

7 Patients Enrolled for Postoperative Pain

Media Library

ropivacaine 0.2% (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT05091905 — Phase 4

Postoperative Pain Research Study Groups: Continuous Infusion, Titratable Automated Boluses

Postoperative Pain Clinical Trial 2023: ropivacaine 0.2% Highlights & Side Effects. Trial Name: NCT05091905 — Phase 4

ropivacaine 0.2% (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05091905 — Phase 4

Frequently Asked Questions

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

Are enrollment slots still available for this clinical trial?

"At present, no participants are being recruited for this medical trial. It was initially posted on February 14th 2022 and the latest update came out April 19th of the same year. If you're looking to join other trials, 600 studies assessing acute pain and 67 trials concerning titratable automated intermittent boluses of ropivacaine 0.2% are currently recruiting patients."

Answered by AI

What potential risks should be considered when administering Titratable Automated Intermittent Boluses of ropivacaine 0.2%?

"Our team rated the safety of Titratable Automated Intermittent Boluses of ropivacaine 0.2% with a score 3, as it is an FDA-approved Phase 4 trial."

Answered by AI

What goals have been outlined to be achieved with this research?

"This research seeks to evaluate the Average Pain queried on First postoperative day over 8 days. Secondary metrics of measurement include Sleep disturbances due to pain, Numbness in foot and ankle, and Current pain which will be rated from 0-10 respectively."

Answered by AI

How many participants are enrolled in this experimental protocol?

"This clinical trial has closed its recruitment phase, having first been posted on February 14th and last edited on April 19th. Alternatives include 600 studies focusing on acute pain and 67 trails examining Titratable Automated Intermittent Boluses of ropivacaine 0.2%."

Answered by AI

What conditions typically warrant Titratable Automated Intermittent Boluses of ropivacaine 0.2%?

"Ropivacaine 0.2% administered through Titratable Automated Intermittent Boluses can help to manage anesthesia, labour-related pain and postoperative discomfort."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Patient-Titrated Automated Intermittent Boluses of Local Anesthetic vs. a Continuous Infusion Via a Perineural Catheter for Postoperative Analgesia

Brian M. Ilfeld, MD, MS 2022. "Patient-Titrated Automated Intermittent Boluses of Local Anesthetic vs. a Continuous Infusion Via a Perineural Catheter for Postoperative Analgesia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05091905.

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