Programmed Intermittent Bolus for Infusion of Local Anesthetic During Continuous Interscalene Nerve Blockade for Total Shoulder Arthroplasty: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Pain score on 11 point (0 - 10) numeric rating scale
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Programmed Intermittent Bolus (Device)
Continuous Infusion
The control (standard care) group will receive the study solution at a rate of 5mL/h continuously via the current infusion pump.
Intervention: Continuous Infusion (Device)
Outcomes
Primary Outcomes
Pain score on 11 point (0 - 10) numeric rating scale
Time Frame: FIrst 24 hour since the operation
Postoperative pain score
Secondary Outcomes
- Side effect(through to patient discharge, on average 48 hours)
- Local anesthetic consumption(36 hours (or until block discontinuation))
- Block complication(through to patient discharge, on average 48 hours)
- Opioid consumption(48 hours (or until discharge))
- patient satisfaction(through to patient discharge, on average 48 hours)
Investigators
Shalini Dhir
Associate Professor
Lawson Health Research Institute