Perineural Local Anesthetic Administration With a Continuous Infusion Versus Automatic Intermittent Boluses

NCT04458467 | Completed Results FDA Device

• 1 other identifier: Auto Intermittent Boluses
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a randomized comparison of continuous local anesthetic infusion with patient controlled boluses (PCA) to automated boluses with PCA for continuous popliteal sciatic nerve blocks. The goal will be to determine the relationship between method of local anesthetic administration (continuous with PCA initiated at discharge vs. intermittent dosing with PCA with a 5-hour delay) for continuous peripheral nerve block and the resulting pain control and duration of analgesia.

Conditions

Pain, Acute; Anesthesia, Local; Trauma Injury

Outcome Measures

Primary Outcomes (2)

• Average Pain Queried on First Postoperative Day

  Rated 0-10 on numeric rating scale the average pain from the recovery room until the data collection call. "0" represents no pain and "10" represents worst imaginable pain. Thus, a lower pain score corresponds to less pain.

  postoperative day 1

• Duration of Infusion

  Number of hours from the time the pump is initiated until local anesthetic reservoir exhaustion

  6 days postoperatively

Secondary Outcomes (7)

• Worst Pain

  Each of 6 days postoperatively

• Average Pain

  Each of 6 days postoperatively

• Least Pain

  Each of 6 days postoperatively

• Current Pain

  Each of 6 days postoperatively

• Opioid Consumption

  Each of 6 days postoperatively

Study Arms (2)

Continuous Infusion

ACTIVE COMPARATOR

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

Device: Continuous Infusion

Automated Boluses

EXPERIMENTAL

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

Device: Automated Intermittent Boluses

Interventions

Continuous Infusion DEVICE

A continuous infusion of ropivacaine 0.2% (6 mL/hr, 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room.

Continuous Infusion

Automated Intermittent Boluses DEVICE

Administration of automated intermittent boluses of ropivacaine 0.2% (8 mL every 2 hr with 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room, but with a 5-hour delay for the first bolus (can be overridden by patients if they would like to initiate their perineural infusion earlier than 5 hours).

Automated Boluses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing painful foot and/or ankle surgery with a planned popliteal sciatic perineural catheter for postoperative analgesia
• age 18 years or older.

You may not qualify if:

• Current daily opioid use within the previous 4 weeks
• Clinical neuro-muscular deficit of either the sciatic nerve and its branches and/or innervating muscles
• Morbid obesity \[weight \> 35 kg/m2\]; surgery outside of ipsilateral sciatic and saphenous nerve distributions
• Pregnancy \[as determined by a urine pregnancy test prior to any study interventions\]
• Incarceration.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Medical Center (Hillcrest and Thornton)

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Acute Pain; Accidental Injuries

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Results Point of Contact

• Title: John Finneran
• Organization: UC San Diego

jfinneran@health.ucsd.edu

(619) 543-2202

Study Officials

• Brian M Ilfeld, MD, MS

  University California San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Residence

Study Record Dates

• First Submitted: June 21, 2020
• First Posted: July 7, 2020
• Study Start: July 15, 2020
• Primary Completion: March 12, 2021
• Study Completion: March 16, 2021
• Last Updated: June 30, 2022
• Results First Posted: May 18, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)