Initial Local Anesthetic Dose With Continuous Interscalene Analgesia
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|ClinicalTrials.gov Identifier: NCT00672100|
Recruitment Status : Completed
First Posted : May 6, 2008
Results First Posted : May 23, 2013
Last Update Posted : March 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Post-operative Pain||Drug: Ropivacaine||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||August 2010|
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
- Pain Measurements Via Numeric Pain Rating Scales (NRS) [ Time Frame: Discharge, 24 h, 48h, 12 weeks ]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 ]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 ]
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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|