- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00672100
Initial Local Anesthetic Dose With Continuous Interscalene Analgesia
January 23, 2017 updated by: William Beaumont Hospitals
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
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
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Royal Oak, Michigan, United States, 48073
- William Beaumont Hospital
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Troy, Michigan, United States, 48085
- William Beaumont Hospitals
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: A
Initial Bolus 5 ml Ropivacaine
|
Initial Bolus 5 ml Ropivacaine via interscalene injection
Initial Bolus 10 ml Ropivacaine via interscalene injection
Initial Bolus 20 ml Ropivacaine via interscalene injection
|
ACTIVE_COMPARATOR: B
Initial Bolus 10 ml Ropivacaine
|
Initial Bolus 5 ml Ropivacaine via interscalene injection
Initial Bolus 10 ml Ropivacaine via interscalene injection
Initial Bolus 20 ml Ropivacaine via interscalene injection
|
ACTIVE_COMPARATOR: C
Initial Bolus 20 ml Ropivacaine
|
Initial Bolus 5 ml Ropivacaine via interscalene injection
Initial Bolus 10 ml Ropivacaine via interscalene injection
Initial Bolus 20 ml Ropivacaine via interscalene injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Discharge, 24 h, 48h, 12 weeks
|
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.
|
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"
Time Frame: at 24 and 48 hours after discharge from the hospital
|
Participants were asked to rate the helpfulness of their infusion:
|
at 24 and 48 hours after discharge from the hospital
|
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.
|
Baseline, 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (ACTUAL)
February 1, 2010
Study Completion (ACTUAL)
August 1, 2010
Study Registration Dates
First Submitted
May 2, 2008
First Submitted That Met QC Criteria
May 2, 2008
First Posted (ESTIMATE)
May 6, 2008
Study Record Updates
Last Update Posted (ACTUAL)
March 7, 2017
Last Update Submitted That Met QC Criteria
January 23, 2017
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HIC 2007-198
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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