Recruiting

Intermittent Bolus

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT03268837

Conditions

Shoulder Arthroplasty

Shoulder Osteoarthritis

Pain Management

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Programmed Intermittent Bolus

Continuous Infusion

Study Details

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.

Conditions

Shoulder Arthroplasty

Shoulder Osteoarthritis

Pain Management

Study ID

NCT03268837

Start date

Jan 1, 2022

Status verified date

Oct, 2023

Completion date

Dec, 2024

Anticipated

Primary completion date

Jul, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: Continuous Infusion

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

Interventions

Programmed Intermittent Bolus

The Smith CADD(R)-Solis Ambulatory Infusion Pump will be used to provide programmed intermittent bolus for the interscalene block.

Continuous Infusion

The Smith CADD(R)-Solis Ambulatory Infusion Pump will be used to provide continuous infusion for the interscalene block.

Primary outcome measure

  • Pain score on 11 point (0 - 10) numeric rating scale [ Time Frame: FIrst 24 hour since the operation ]

Central Contacts and Locations

Central contacts

Bill Lin, FRCPC

+15196466000cheng.lin@lhsc.on.ca

Locations

St. Joseph's Health Care London

Recruiting

London, Ontario, Canada, N6A 4V2

Contacts

Cheng Lin, FRCPC

5196858500cheng.lin@lhsc.on.ca

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Oct 3, 2023

Last verified

Oct, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2023-10-03.