Programmed Intermittent Bolus During Continuous Interscalene Nerve Block for Shoulder Arthroplasty
- Conditions
- Shoulder ArthroplastyPain ManagementShoulder Osteoarthritis
- Interventions
- Device: Programmed Intermittent BolusDevice: Continuous Infusion
- Registration Number
- NCT03268837
- Lead Sponsor
- Lawson Health Research Institute
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 110
- Adult patients
- American Society of Anesthesiologists (ASA) Physical Status I to III
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Programmed Intermittent Bolus (PIB) Programmed Intermittent Bolus For the experimental group, patients will receive 5 mL of the study solution as a bolus every hour via a PIB-capable infusion pump. Continuous Infusion Continuous Infusion The control (standard care) group will receive the study solution at a rate of 5mL/h continuously via the current infusion pump.
- Primary Outcome Measures
Name Time Method Pain score on 11 point (0 - 10) numeric rating scale FIrst 24 hour since the operation Postoperative pain score
- Secondary Outcome Measures
Name Time Method Side effect through to patient discharge, on average 48 hours nausea, voting, pruritus
Local anesthetic consumption 36 hours (or until block discontinuation) The total dose of local anesthetic used until the block is discontinued
Block complication through to patient discharge, on average 48 hours persistent motor or sensory block, dyspnea, hoarseness, Horner syndrome
Opioid consumption 48 hours (or until discharge) The total amount of opioids consumed will be recorded until the patient is discharged
patient satisfaction through to patient discharge, on average 48 hours 100 mm visual analogue scale
Trial Locations
- Locations (1)
St. Joseph's Health Care London
🇨🇦London, Ontario, Canada