Continuous Infusions vs Scheduled Bolus Infusions

A Prospective Comparison of Pain and Analgesia in Patients With Continuous Peripheral Nerve Block Catheters Using Continuous Infusion or Scheduled Bolus Infusion

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Surgical Procedure, Unspecified
• Intervention / Treatment: Drug: Ropivacaine; Drug: Ropivacaine

Detailed Description

Regional anesthetic techniques are an integral part to many anesthetic approaches, providing both intraoperative and postoperative anesthesia and analgesia. Regional anesthesia peripheral nerve blocks have been shown to reduce postoperative pain and improve measures such as opioid requirements and readiness for discharge. By using a catheter technique for continuous peripheral nerve blocks, analgesia can be extended well into post-operative days 2 and 3, further extending these benefits. Historically these catheters have implemented a continuous dosing regimen of local anesthetic, but increasingly there is evidence of improved analgesic outcomes without adverse effects by using a scheduled bolus dosing regimen. Many institutions have implemented this new protocol for catheter dosing. The beneficial effect of scheduled bolus dosing has not been studied in all blocks and all surgical procedures.

The study will consist of three independent arms, each designed to evaluate a different nerve block site: interscalene, adductor canal, and infraclavicular. A total of 60 patients will be enrolled in each arm.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Aaron J Deng, BS; Phone Number: 408-914-5494; Email: adeng1@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford University
      • Contact: Archana Verma
      • Principal Investigator: Jean Louis-Horn, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Continuous Infusion; Local anesthetic medication (Ropivacaine 0.2%) is provided at a continuous basal rate.	Drug: Ropivacaine; Patient will be given a continuous infusion of local anesthetic.; Other Names: Continuous infusion; Drug: Ropivacaine; Patient will be given a scheduled intermittent bolus of local anesthetic.; Other Names: Bolus Infusion
Active Comparator: Intermittent Bolus Infusion; Local anesthetic medication (Ropivacaine 0.2%) is provided in scheduled, intermittent boluses.	Drug: Ropivacaine; Patient will be given a continuous infusion of local anesthetic.; Other Names: Continuous infusion; Drug: Ropivacaine; Patient will be given a scheduled intermittent bolus of local anesthetic.; Other Names: Bolus Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption	The amount of opioid analgesics (converted to total morphine milligram equivalents) taken by patients will be recorded.	Post-operative day 0, 1, and 2
Local anesthetic use	The amount of supplemental local anesthetic boluses self-administered by patients will be recorded (in mL).	Post-operative day 1 and 2
Quality of recovery	Quality of recovery will be assessed using a Quality of Recovery (QoR-15) questionnaire. The QoR15 scores range from 0 to 150, where 0 is poor recovery and 150 is excellent recovery.	Post-operative day 1 and 2
Evidence of diaphragmatic paralysis	Ability to breathe will be assessed as a part of QoR-15 questionnaire on 11-point scale, where 0 is never being able to breathe easily and 10 is always being able to breathe easily.	Post-operative day 1 and 2
Patient satisfaction	Patients will be asked to assess their satisfaction with pain management (Yes/No).	Post-operative day 1 and 2

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Jean Louis-Horn, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 24, 2017
• First Submitted That Met QC Criteria: July 25, 2017
• First Posted (Actual): July 26, 2017

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Ropivacaine
• Other Study ID Numbers: 41434

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No