Clinical trial NCT03268837: Programmed Intermittent Bolus During Continuous Interscalene Nerve Block for Shoulder Arthroplasty
Official title: Programmed Intermittent Bolus for Infusion of Local Anesthetic During Continuous Interscalene Nerve Blockade for Total Shoulder Arthroplasty: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shoulder Arthroplasty
Shoulder Osteoarthritis
Pain Management
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2017-08-31
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain score on 11 point (0 - 10) numeric rating scale
timeFrame: FIrst 24 hour since the operation
Secondary outcomes:
measure: Local anesthetic consumption
timeFrame: 36 hours (or until block discontinuation)
measure: Opioid consumption
timeFrame: 48 hours (or until discharge)
measure: Side effect
timeFrame: through to patient discharge, on average 48 hours
measure: patient satisfaction
timeFrame: through to patient discharge, on average 48 hours
measure: Block complication
timeFrame: through to patient discharge, on average 48 hours
Other outcomes:
Locations:
city: London
country: Canada
facility: St. Joseph's Health Care London
state: Ontario
Study officials:
References:
citation: Chong MA, Wang Y, Dhir S, Lin C. Programmed intermittent peripheral nerve local anesthetic bolus compared with continuous infusions for postoperative analgesia: A systematic review and meta-analysis. J Clin Anesth. 2017 Nov;42:69-76. doi: 10.1016/j.jclinane.2017.08.018. Epub 2017 Aug 19.