Local Anesthetic Delivery Methods for Postoperative Pain

Recruiting in Palo Alto (17 mi)

Brian M. Ilfeld, MD - Anesthesiology ...

Overseen byBrian Ilfeld, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of California, San Diego

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This will be a randomized comparison of continuous local anesthetic infusion with patient controlled boluses (PCA) to patient-titratable automated boluses with patient controlled boluses (PCA) for both infraclavicular and popliteal-sciatic perineural catheters. The overall goal is to determine the relationship between method of local anesthetic administration (continuous with PCA vs. titratable intermittent dosing with PCA) for these two perineural catheter locations and the resulting pain control. The investigators hypothesize that, compared with a traditional fixed, continuous basal infusion initiated prior to discharge, perineural local anesthetic administered with titratable automated boluses at a lower dose and a 5-hour delay following discharge will (1) provide at least noninferior analgesia during the period that both techniques are functioning; and, (2) will result in a longer overall duration of administration \[dual primary end points\].

Research Team

Brian Ilfeld, MD

Principal Investigator

University of California, San Diego

Eligibility Criteria

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.

Inclusion Criteria

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

Exclusion Criteria

You have been taking opioid pain medication every day in the last 4 weeks.

Pregnancy

You are in prison.

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Treatment Details

Interventions

ropivacaine 0.2% (Local Anesthetic)

Trial OverviewThe 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.

Participant Groups

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).