Programmed Intermittent Bolus During Continuous Interscalene Nerve Block for Shoulder Arthroplasty

Lawson Health Research Institute

Status: Enrolling

Conditions: Shoulder Osteoarthritis; Pain Management; Shoulder Arthroplasty

Treatments: Device: Continuous Infusion; Device: Programmed Intermittent Bolus

Study type: Interventional

Funder types: Other

Identifiers

NCT03268837

109624 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 2 patient groups

Programmed Intermittent Bolus (PIB)

Experimental group

Description:

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

Treatment:

Device: Programmed Intermittent Bolus

Continuous Infusion

Active Comparator group

Description:

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

Treatment:

Device: Continuous Infusion