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.
Aims: 1. 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. 2. 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. 3. To compare impairment in diaphragmatic excursion at discharge from PACU following 5, 10, and 20 ml boluses. 4. To compare patients' satisfaction with analgesia at 24 and 48 hours following 5, 10, and 20 ml boluses. 5. To compare patient rating of functional outcome at baseline and at 12 weeks following 5, 10, and 20 ml boluses. 6. To compare the rate of general anesthesia required following 5, 10, and 20 ml boluses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
36
Initial Bolus 5 ml Ropivacaine via interscalene injection
Initial Bolus 10 ml Ropivacaine via interscalene injection
Initial Bolus 20 ml Ropivacaine via interscalene injection
William Beaumont Hospital
Royal Oak, Michigan, United States
William Beaumont Hospitals
Troy, Michigan, United States
Pain Measurements Via Numeric Pain Rating Scales (NRS)
Pain was reported via NRS ranging from 0 (no pain) to 10 (worst pain imaginable)
Time frame: 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.
Time frame: Baseline, Post anesthesia care unit (PACU) - within 8 hours
Percentage of Participants Who Considered the Analgesic Technique "Helpful" or "Extremely Helpful"
Participants were asked to rate the helpfulness of their infusion: 1. extremely harmful 2. harmful 3. neutral 4. not harmful, but not helpful 5. helpful 6. extremely helpful
Time frame: 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.
Time frame: Baseline, 12 weeks
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