Programmed Intermittent Bolus During Continuous Interscalene Nerve Block for Shoulder Arthroplasty

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-12-31

Brief Summary

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A new infusion strategy named the 'programmed intermittent bolus' (PIB) technique delivers the hourly dose within minutes compared to the traditional infusion that delivers such dose over an hour. The PIB technique has demonstrated superior patient satisfaction and reduced local anesthetic consumption when utilized for pain control during labour and delivery. However, it is not known if the PIB technique gives any benefits during a continuous nerve block in other settings. The aim of this randomized controlled trial (RCT) is to elucidate if PIB is better than (traditional) continuous infusion for postoperative analgesia in patients receiving a continuous nerve block for total shoulder arthroplasty with respect to pain control.

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Detailed Description

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Local anesthetics are often given in a continuous fashion to block specific nerves after an operation for pain control. A new infusion strategy named the 'programmed intermittent bolus' (PIB) technique delivers the hourly dose within minutes compared to the traditional infusion that delivers such dose over an hour. The PIB technique has demonstrated superior patient satisfaction and reduced local anesthetic consumption when utilized for pain control during labour and delivery. However, it is not known if the PIB technique gives any benefits during a continuous nerve block in other settings. The aim of this randomized controlled trial (RCT) is to elucidate if PIB is better than (traditional) continuous infusion for postoperative analgesia in patients receiving a continuous nerve block for total shoulder arthroplasty with respect to pain control.

Conditions

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Shoulder Arthroplasty Shoulder Osteoarthritis Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Programmed Intermittent Bolus (PIB)

For the experimental group, patients will receive 5 mL of the study solution as a bolus every hour via a PIB-capable infusion pump.

Group Type EXPERIMENTAL

Programmed Intermittent Bolus

Intervention Type DEVICE

The Smith CADD(R)-Solis Ambulatory Infusion Pump will be used to provide programmed intermittent bolus for the interscalene block.

Continuous Infusion

The control (standard care) group will receive the study solution at a rate of 5mL/h continuously via the current infusion pump.

Group Type ACTIVE_COMPARATOR

Continuous Infusion

Intervention Type DEVICE

The Smith CADD(R)-Solis Ambulatory Infusion Pump will be used to provide continuous infusion for the interscalene block.

Interventions

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Programmed Intermittent Bolus

The Smith CADD(R)-Solis Ambulatory Infusion Pump will be used to provide programmed intermittent bolus for the interscalene block.

Intervention Type DEVICE

Continuous Infusion

The Smith CADD(R)-Solis Ambulatory Infusion Pump will be used to provide continuous infusion for the interscalene block.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult patients
* American Society of Anesthesiologists (ASA) Physical Status I to III

Exclusion Criteria

* Body mass index (BMI) \> 40
* Not able to communicate in ENglish
* Unable to obtain consent
* Infection over site of placement
* Severe respiratory disease
* Cognitive or psychiatric history that would make it difficult to assess pain score
* Complex regional pain syndrome
* Chronic pain condition such as fibromyalgia, neuropathic pain
* Preoperative opioid use greater than the equivalent of morphine 50 mg PO daily
* Allergy to any of the study drug
* Coagulopathy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No