Continuous Infusions vs Scheduled Bolus Infusions

NCT03230565 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 41434
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the study is to compare continuous infusions and scheduled bolus infusions for peripheral nerve blocks and their effect on post-surgical pain.

Conditions

Surgical Procedure, Unspecified; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Post-surgical pain

  Pain scores will be collected using a Numeric Rating Scale (NRS) from 0-10, where 0 is the lowest and 10 is the highest pain level.

  Post-operative day 0, 1, and 2

Secondary Outcomes (5)

• Opioid consumption

  Post-operative day 0, 1, and 2

• Local anesthetic use

  Post-operative day 1 and 2

• Quality of recovery

  Post-operative day 1 and 2

• Evidence of diaphragmatic paralysis

  Post-operative day 1 and 2

• Patient satisfaction

  Post-operative day 1 and 2

Study Arms (2)

Continuous Infusion

ACTIVE COMPARATOR

Local anesthetic medication (Ropivacaine 0.2%) is provided at a continuous basal rate.

Drug: Ropivacaine

Intermittent Bolus Infusion

ACTIVE COMPARATOR

Local anesthetic medication (Ropivacaine 0.2%) is provided in scheduled, intermittent boluses.

Drug: Ropivacaine

Interventions

Ropivacaine DRUG

Patient will be given a continuous infusion of local anesthetic.

Also known as: Continuous infusion

Continuous Infusion

Eligibility Criteria

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

You may qualify if:

• Adult patients presenting for nerve block catheters for post-operative analgesia
• ASA physical status I, II, or III.

You may not qualify if:

• Pregnancy
• Incarceration
• Age \<18
• BMI \>35
• Pre-operative opioid use \>30 mg morphine equivalents per day
• Inability to communicate with investigators by telephone
• Pre-existing neuropathy of the operative extremity.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Jean Louis-Horn, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aaron J Deng, BS

CONTACT

408-914-5494; adeng1@stanford.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators and participants will be masked to treatment group. Care providers will be necessarily unmasked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Model Details: Comparison of two groups: 1) Continuous infusion group 2) Bolus infusion group

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: July 26, 2017
• Study Start: June 1, 2018
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)