Initial Local Anesthetic Dose With Continuous Interscalene Analgesia

Study Overview
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Brief Summary
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Objective: To determine a minimally effective initial local anesthetic bolus required to provide satisfactory analgesia using continuous brachial plexus infusion following arthroscopic shoulder surgery using a double-blind, randomized, study comparing 3 initial doses.

Detailed Description
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Aims: To compare pain ratings and supplemental analgesic requirements at discharge from PACU, 24 hours, and 48 hours and 12 weeks following 5, 10, and 20 ml boluses. To compare adverse events including clinical dysphonia, Horner's syndrome, dyspnea, unexpected hospitalization, evidence of local anesthetic toxicity, and hand weakness at discharge from PACU following 5, 10, and 20 ml boluses. To compare impairment in diaphragmatic excursion at discharge from PACU following 5, 10, and 20 ml boluses. To compare patients' satisfaction with analgesia at 24 and 48 hours following 5, 10, and 20 ml boluses. To compare patient rating of functional outcome at baseline and at 12 weeks following 5, 10, and 20 ml boluses. To compare the rate of general anesthesia required following 5, 10, and 20 ml boluses.

Official Title
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The Effect Of Initial Local Anesthetic Dose With Continuous Interscalene Analgesia On Postoperative Pain And Diaphragmatic Function In Arthroscopic Shoulder Surgery Patients: A Double-Blind, Randomized, Parallel Group, Dose-Ranging Study

Conditions
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Post-operative Pain

Intervention / Treatment
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* Drug: Ropivacaine
* Drug: Ropivacaine
* Drug: Ropivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide written informed consent prior to participation in the study. Is scheduled to undergo Arthroscopic Rotator Cuff Repair, defined as arthroscopically assisted repair of any of the muscles or tendons comprising the rotator cuff. If subject is a female of childbearing potential, have a negative pregnancy test on the day of surgery per standard of care Be at least 18, but not more than 80 years of age Have an ASA risk class of I, II, or III according to the American Society of Anesthesiologists (ASA). Have the ability to read and understand the study procedures and the use of the pain scales. Must have the ability to communicate meaningfully with the Study Investigator and staff. Be free of other physical, mental, or medical conditions, which in the opinion of the Investigator, makes study participation inadvisable. Exclusion Criteria: Subjects requiring daily opioids equivalent to greater than 40 mg oxycodone for over 2 weeks prior to the study. Has significant preexisting pulmonary (respiratory/breathing) disease, diaphragmatic paralysis or history of phrenic nerve injury (problems with the diaphragm causing breathing difficulties). Has significant medical disease(s), laboratory abnormalities or condition(s) that in the Investigator's judgment could compromise the subject's welfare, ability to communicate with the study staff, complete study activities, or would otherwise contraindicate study participation. Has known significant hypersensitivity to opioids, Ropivacaine, or the inactive ingredients (excipients) of the study medications. Has known or suspected history of alcohol or drug abuse or dependence within the previous 2 years. Has clinically significant liver disease, or other condition (e.g., alcoholism, cirrhosis, or hepatitis) based on medical history and examination. Has participated in another clinical Study (investigational or marketed product within 30 days of surgery.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Initial Bolus 5 ml Ropivacaine | Drug: Ropivacaine<br>* Initial Bolus 5 ml Ropivacaine via interscalene injection<br>|
| Active Comparator: B<br>Initial Bolus 10 ml Ropivacaine | Drug: Ropivacaine<br>* Initial Bolus 10 ml Ropivacaine via interscalene injection<br>|
| Active Comparator: C<br>Initial Bolus 20 ml Ropivacaine | Drug: Ropivacaine<br>* Initial Bolus 20 ml Ropivacaine via interscalene injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Measurements Via Numeric Pain Rating Scales (NRS) | Pain was reported via NRS ranging from 0 (no pain) to 10 (worst pain imaginable) | Discharge, 24 h, 48h, 12 weeks | 
| Change in Diaphragmatic Displacement From Baseline to Post-surgery | Diaphragm displacement from exhale to inhale. The baseline diaphragm measurement was obtained pre-operatively before the block was administered prior to surgery. This was again measured post-operatively before the patient's discharge from the Post-anesthesia Care Unit. | Baseline, Post anesthesia care unit (PACU) - within 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Considered the Analgesic Technique Helpful or Extremely Helpful | Participants were asked to rate the helpfulness of their infusion: extremely harmful harmful neutral not harmful, but not helpful helpful extremely helpful | at 24 and 48 hours after discharge from the hospital | 
| Functional Outcome - Simple Shoulder Test (SST) | At baseline and again at 12 weeks subjects completed the Simple Shoulder Test. This test is a series of 12 (yes/no) questions. Participants get 1 point if they answer yes (they can perform the task) and 0 if they answer no. Total possible range is from 0-12. This has been shown to be a valid, reliable and consistent for subjects up to and including 60 years of age when similar injuries (rotator cuff dysfunction) are assessed. | Baseline, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral Nerve Infusion,, continuous brachial plexus block,, post-operative pain, diaphragmatic paresis