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Continuous Infusions vs Scheduled Bolus Infusions

Primary Purpose

Surgical Procedure, Unspecified, Pain, Postoperative

Status
Enrolling by invitation
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine
Ropivacaine
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Procedure, Unspecified

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Enrollment will be offered to adult patients with ASA physical status I, II, or III, presenting for nerve block catheters for post-operative analgesia.

-

Exclusion Criteria: Exclusion criteria will include: pregnancy, incarceration, age <18, BMI >35, pre-operative opioid use >30 mg morphine equivalents per day, inability to communicate with investigators by telephone, and pre-existing neuropathy of the operative extremity.

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Continuous Infusion

Intermittent Bolus Infusion

Arm Description

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

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

Outcomes

Primary Outcome Measures

Post-surgical pain
Patients will rate their pain on a 0-10 scale

Secondary Outcome Measures

Opioid Consumption
Pain medications consumed by patients will be collected

Full Information

First Posted
July 24, 2017
Last Updated
July 21, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT03230565
Brief Title
Continuous Infusions vs Scheduled Bolus Infusions
Official Title
A Prospective Comparison of Pain and Analgesia in Patients With Continuous Peripheral Nerve Block Catheters Using Continuous Infusion or Scheduled Bolus Infusion
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To compare continuous infusions to bolus infusions and there affect on post-surgical pain.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Procedure, Unspecified, Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Comparison of two groups: 1) Continuous infusion group 2) Bolus Infusion group
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Investigators and participants will be masked to treatment group. Care providers will be necessarily unmasked.
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Continuous Infusion
Arm Type
Active Comparator
Arm Description
Local anesthetic medication (Ropivacaine 0.2%) is provided at a continuous basal rate.
Arm Title
Intermittent Bolus Infusion
Arm Type
Active Comparator
Arm Description
Local anesthetic medication (Ropivacaine 0.2%) is provided in scheduled, intermittent boluses.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Continuous infusion
Intervention Description
Patient will be given a continuous infusion of local anesthetic.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Bolus Infusion
Intervention Description
Patient will be given a scheduled intermittent bolus of local anesthetic.
Primary Outcome Measure Information:
Title
Post-surgical pain
Description
Patients will rate their pain on a 0-10 scale
Time Frame
2-3 days after surgery
Secondary Outcome Measure Information:
Title
Opioid Consumption
Description
Pain medications consumed by patients will be collected
Time Frame
2-3 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Enrollment will be offered to adult patients with ASA physical status I, II, or III, presenting for nerve block catheters for post-operative analgesia. - Exclusion Criteria: Exclusion criteria will include: pregnancy, incarceration, age <18, BMI >35, pre-operative opioid use >30 mg morphine equivalents per day, inability to communicate with investigators by telephone, and pre-existing neuropathy of the operative extremity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Louis-Horn, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Continuous Infusions vs Scheduled Bolus Infusions

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