Programmed Intermittent Bolus During Continuous Interscalene Nerve Block for Shoulder Arthroplasty
Primary Purpose
Shoulder Arthroplasty, Shoulder Osteoarthritis, Pain Management
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Programmed Intermittent Bolus
Continuous Infusion
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Arthroplasty
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
Sites / Locations
- St. Joseph's Health Care LondonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Programmed Intermittent Bolus (PIB)
Continuous Infusion
Arm Description
For the experimental group, patients will receive 5 mL of the study solution as a bolus every hour via a PIB-capable infusion pump.
The control (standard care) group will receive the study solution at a rate of 5mL/h continuously via the current infusion pump.
Outcomes
Primary Outcome Measures
Pain score on 11 point (0 - 10) numeric rating scale
Postoperative pain score
Secondary Outcome Measures
Local anesthetic consumption
The total dose of local anesthetic used until the block is discontinued
Opioid consumption
The total amount of opioids consumed will be recorded until the patient is discharged
Side effect
nausea, voting, pruritus
patient satisfaction
100 mm visual analogue scale
Block complication
persistent motor or sensory block, dyspnea, hoarseness, Horner syndrome
Full Information
NCT ID
NCT03268837
First Posted
August 28, 2017
Last Updated
October 2, 2023
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03268837
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Arthroplasty, Shoulder Osteoarthritis, Pain Management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Programmed Intermittent Bolus (PIB)
Arm Type
Experimental
Arm Description
For the experimental group, patients will receive 5 mL of the study solution as a bolus every hour via a PIB-capable infusion pump.
Arm Title
Continuous Infusion
Arm Type
Active Comparator
Arm Description
The control (standard care) group will receive the study solution at a rate of 5mL/h continuously via the current infusion pump.
Intervention Type
Device
Intervention Name(s)
Programmed Intermittent Bolus
Intervention Description
The Smith CADD(R)-Solis Ambulatory Infusion Pump will be used to provide programmed intermittent bolus for the interscalene block.
Intervention Type
Device
Intervention Name(s)
Continuous Infusion
Intervention Description
The Smith CADD(R)-Solis Ambulatory Infusion Pump will be used to provide continuous infusion for the interscalene block.
Primary Outcome Measure Information:
Title
Pain score on 11 point (0 - 10) numeric rating scale
Description
Postoperative pain score
Time Frame
FIrst 24 hour since the operation
Secondary Outcome Measure Information:
Title
Local anesthetic consumption
Description
The total dose of local anesthetic used until the block is discontinued
Time Frame
36 hours (or until block discontinuation)
Title
Opioid consumption
Description
The total amount of opioids consumed will be recorded until the patient is discharged
Time Frame
48 hours (or until discharge)
Title
Side effect
Description
nausea, voting, pruritus
Time Frame
through to patient discharge, on average 48 hours
Title
patient satisfaction
Description
100 mm visual analogue scale
Time Frame
through to patient discharge, on average 48 hours
Title
Block complication
Description
persistent motor or sensory block, dyspnea, hoarseness, Horner syndrome
Time Frame
through to patient discharge, on average 48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bill Lin, FRCPC
Phone
+15196466000
Ext
64219
Email
cheng.lin@lhsc.on.ca
Facility Information:
Facility Name
St. Joseph's Health Care London
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheng Lin, FRCPC
Phone
5196858500
Ext
15896
Email
cheng.lin@lhsc.on.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28830037
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.
Results Reference
result
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Programmed Intermittent Bolus During Continuous Interscalene Nerve Block for Shoulder Arthroplasty
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