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Initial Local Anesthetic Dose With Continuous Interscalene Analgesia

This study has been completed.
Sponsor:
Collaborator:
Beaumont Foundation of America
Information provided by (Responsible Party):
Craig Hartrick, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00672100
First received: May 2, 2008
Last updated: May 22, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention
Post-operative Pain
 Drug: Ropivacaine

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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:

    1. extremely harmful
    2. harmful
    3. neutral
    4. not harmful, but not helpful
    5. helpful
    6. 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.


Enrollment: 36
Study Start Date: January 2009
Study Completion Date: August 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Initial Bolus 5 ml Ropivacaine
 Drug: Ropivacaine
Initial Bolus 5 ml Ropivacaine via interscalene injection
Active Comparator: B
Initial Bolus 10 ml Ropivacaine
 Drug: Ropivacaine
Initial Bolus 10 ml Ropivacaine via interscalene injection
Active Comparator: C
Initial Bolus 20 ml Ropivacaine
 Drug: Ropivacaine
Initial Bolus 20 ml Ropivacaine via interscalene injection

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00672100

Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
William Beaumont Hospitals
Troy, Michigan, United States, 48085
Sponsors and Collaborators
William Beaumont Hospitals
Beaumont Foundation of America
Investigators
Principal Investigator: Craig Hartrick, MD William Beaumont Hospitals
  More Information

Publications:

Responsible Party: Craig Hartrick, MD, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00672100     History of Changes
Other Study ID Numbers: HIC 2007-198
Study First Received: May 2, 2008
Results First Received: July 12, 2011
Last Updated: May 22, 2013
Health Authority: United States: William Beaumont Research Institute Human Investigation Committee

Keywords provided by William Beaumont Hospitals:
Peripheral Nerve Infusion,
continuous brachial plexus block,
post-operative pain
diaphragmatic paresis

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Anesthetics, Local
Ropivacaine
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013