NCT03268837

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2017

Completed
4.3 years until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

October 3, 2023

Status Verified

October 1, 2023

Enrollment Period

2.5 years

First QC Date

August 28, 2017

Last Update Submit

October 2, 2023

Conditions

Shoulder ArthroplastyShoulder OsteoarthritisPain Management

Outcome Measures

Primary Outcomes (1)

  • Pain score on 11 point (0 - 10) numeric rating scale

    Postoperative pain score

    FIrst 24 hour since the operation

Secondary Outcomes (5)

  • Local anesthetic consumption

    36 hours (or until block discontinuation)

  • Opioid consumption

    48 hours (or until discharge)

  • Side effect

    through to patient discharge, on average 48 hours

  • patient satisfaction

    through to patient discharge, on average 48 hours

  • Block complication

    through to patient discharge, on average 48 hours

Study Arms (2)

Programmed Intermittent Bolus (PIB)

EXPERIMENTAL

For the experimental group, patients will receive 5 mL of the study solution as a bolus every hour via a PIB-capable infusion pump.

Device: Programmed Intermittent Bolus

Continuous Infusion

ACTIVE COMPARATOR

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

Device: Continuous Infusion

Interventions

Programmed Intermittent BolusDEVICE

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

Programmed Intermittent Bolus (PIB)
Continuous InfusionDEVICE

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

Continuous Infusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients
  • American Society of Anesthesiologists (ASA) Physical Status I to III

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Health Care London

London, Ontario, N6A 4V2, Canada

RECRUITING

Related Publications (1)

  • 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.

    PMID: 28830037RESULT

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Bill Lin, FRCPC

CONTACT

+15196466000cheng.lin@lhsc.on.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 28, 2017

First Posted

August 31, 2017

Study Start

January 1, 2022

Primary Completion

July 1, 2024

Study Completion

December 1, 2024

Last Updated

October 3, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)