Programmed Intermittent Bolus During Continuous Interscalene Nerve Block for Shoulder Arthroplasty

Programmed Intermittent Bolus for Infusion of Local Anesthetic During Continuous Interscalene Nerve Blockade for Total Shoulder Arthroplasty: a Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Pain Management; Shoulder Arthroplasty; Shoulder Osteoarthritis
• Intervention / Treatment: Device: Programmed Intermittent Bolus; Device: Continuous Infusion

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.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bill Lin, FRCPC; Phone Number: 64219 +15196466000; Email: cheng.lin@lhsc.on.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • Recruiting
      • St. Joseph's Health Care London
      • Contact: Cheng Lin, FRCPC; Phone Number: 15896 5196858500; Email: cheng.lin@lhsc.on.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Programmed Intermittent Bolus; The Smith CADD(R)-Solis Ambulatory Infusion Pump will be used to provide programmed intermittent bolus for the interscalene block.
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.	Device: Continuous Infusion; The Smith CADD(R)-Solis Ambulatory Infusion Pump will be used to provide continuous infusion for the interscalene block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score on 11 point (0 - 10) numeric rating scale	Postoperative pain score	FIrst 24 hour since the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local anesthetic consumption	The total dose of local anesthetic used until the block is discontinued	36 hours (or until block discontinuation)
Opioid consumption	The total amount of opioids consumed will be recorded until the patient is discharged	48 hours (or until discharge)
Side effect	nausea, voting, pruritus	through to patient discharge, on average 48 hours
patient satisfaction	100 mm visual analogue scale	through to patient discharge, on average 48 hours
Block complication	persistent motor or sensory block, dyspnea, hoarseness, Horner syndrome	through to patient discharge, on average 48 hours

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 28, 2017
• First Submitted That Met QC Criteria: August 29, 2017
• First Posted (Actual): August 31, 2017

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 109624 (GSK)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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