Initial Local Anesthetic Dose With Continuous Interscalene Analgesia
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- Pain Measurements Via Numeric Pain Rating Scales (NRS) [ Time Frame: Discharge, 24 h, 48h, 12 weeks ] [ Designated as safety issue: No ]Pain was reported via NRS ranging from 0 (no pain) to 10 (worst pain imaginable)
- Change in Diaphragmatic Displacement From Baseline to Post-surgery [ Time Frame: Baseline, Post anesthesia care unit (PACU) - within 8 hours ] [ Designated as safety issue: Yes ]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.
- Percentage of Participants Who Considered the Analgesic Technique "Helpful" or "Extremely Helpful" [ Time Frame: at 24 and 48 hours after discharge from the hospital ] [ Designated as safety issue: No ]
Participants were asked to rate the helpfulness of their infusion:
- extremely harmful
- not harmful, but not helpful
- extremely helpful
- Functional Outcome - Simple Shoulder Test (SST) [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]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.
|Study Start Date:||January 2009|
|Study Completion Date:||August 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Active Comparator: A
Initial Bolus 5 ml Ropivacaine
Initial Bolus 5 ml Ropivacaine via interscalene injection
Active Comparator: B
Initial Bolus 10 ml Ropivacaine
Initial Bolus 10 ml Ropivacaine via interscalene injection
Active Comparator: C
Initial Bolus 20 ml Ropivacaine
Initial Bolus 20 ml Ropivacaine via interscalene injection
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00672100
|United States, Michigan|
|William Beaumont Hospital|
|Royal Oak, Michigan, United States, 48073|
|William Beaumont Hospitals|
|Troy, Michigan, United States, 48085|
|Principal Investigator:||Craig Hartrick, MD||William Beaumont Hospitals|