Continuous Infusions vs Scheduled Bolus Infusions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Surgical Procedure, Unspecified Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Investigators and participants will be masked to treatment group. Care providers will be necessarily unmasked.

Study Groups

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Continuous Infusion

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

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

Patient will be given a continuous infusion of local anesthetic.

Intermittent Bolus Infusion

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

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

Patient will be given a scheduled intermittent bolus of local anesthetic.

Interventions

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Ropivacaine

Patient will be given a continuous infusion of local anesthetic.

Intervention Type DRUG

Ropivacaine

Patient will be given a scheduled intermittent bolus of local anesthetic.

Intervention Type DRUG

Other Intervention Names

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Continuous infusion Bolus Infusion

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No