Programmed Intermittent Bolus During Continuous Interscalene Nerve Block for Shoulder Arthroplasty

Pain Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03268837
• Other study ID #: 109624
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Lawson Health Research Institute
• Contact: Bill Lin, FRCPC
• Phone: +15196466000
• Email: cheng.lin[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Pain Management
• Shoulder Arthroplasty
• Shoulder Osteoarthritis

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Canada	St. Joseph's Health Care London	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

References & 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.jclina — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score on 11 point (0 - 10) numeric rating scale	Postoperative pain score	FIrst 24 hour since the operation
Secondary	Local anesthetic consumption	The total dose of local anesthetic used until the block is discontinued	36 hours (or until block discontinuation)
Secondary	Opioid consumption	The total amount of opioids consumed will be recorded until the patient is discharged	48 hours (or until discharge)
Secondary	Side effect	nausea, voting, pruritus	through to patient discharge, on average 48 hours
Secondary	patient satisfaction	100 mm visual analogue scale	through to patient discharge, on average 48 hours
Secondary	Block complication	persistent motor or sensory block, dyspnea, hoarseness, Horner syndrome	through to patient discharge, on average 48 hours