Continuous Infusions vs Scheduled Bolus Infusions
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University
About this trial
The goal of the study is to compare continuous infusions and scheduled bolus infusions for peripheral nerve blocks and their effect on post-surgical pain.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients presenting for nerve block catheters for post-operative analgesia
ASA physical status I, II, or III.
Disqualifiers
Pregnancy
Incarceration
Age <18
BMI >35
Trial design
Design model
Parallel
Treatments tested in this trial
Ropivacaine
DrugPatient will be given a continuous infusion of local anesthetic.
Ropivacaine
DrugPatient will be given a scheduled intermittent bolus of local anesthetic.
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: Continuous InfusionActive comparator 1 intervention
Group B: Intermittent Bolus InfusionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Post-surgical pain
Pain scores will be collected using a Numeric Rating Scale (NRS) from 0-10, where 0 is the lowest and 10 is the highest pain level.
Time frame
Post-operative day 0, 1, and 2Secondary outcomes
1
Opioid consumption
The amount of opioid analgesics (converted to total morphine milligram equivalents) taken by patients will be recorded.
Time frame
Post-operative day 0, 1, and 22
Local anesthetic use
The amount of supplemental local anesthetic boluses self-administered by patients will be recorded (in mL).
Time frame
Post-operative day 1 and 23
Quality of recovery
Quality of recovery will be assessed using a Quality of Recovery (QoR-15) questionnaire. The QoR15 scores range from 0 to 150, where 0 is poor recovery and 150 is excellent recovery.
Time frame
Post-operative day 1 and 24
Evidence of diaphragmatic paralysis
Ability to breathe will be assessed as a part of QoR-15 questionnaire on 11-point scale, where 0 is never being able to breathe easily and 10 is always being able to breathe easily.
Time frame
Post-operative day 1 and 2Sponsors and contacts
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Source ClinicalTrials.gov