Shoulder Arthroplasty, Shoulder Osteoarthritis, Pain Management
Conditions
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.
Interventions
The Smith CADD(R)-Solis Ambulatory Infusion Pump will be used to provide programmed intermittent bolus for the interscalene block.
DEVICEContinuous Infusion
The Smith CADD(R)-Solis Ambulatory Infusion Pump will be used to provide continuous infusion for the interscalene block.
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score on 11 point (0 - 10) numeric rating scale | FIrst 24 hour since the operation | Postoperative pain score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local anesthetic consumption | 36 hours (or until block discontinuation) | The total dose of local anesthetic used until the block is discontinued |
| Opioid consumption | 48 hours (or until discharge) | The total amount of opioids consumed will be recorded until the patient is discharged |
| Side effect | through to patient discharge, on average 48 hours | nausea, voting, pruritus |
| patient satisfaction | through to patient discharge, on average 48 hours | 100 mm visual analogue scale |
| Block complication | through to patient discharge, on average 48 hours | persistent motor or sensory block, dyspnea, hoarseness, Horner syndrome |
Countries
Canada
Contacts
Primary ContactBill Lin, FRCPC
Outcome results
None listed