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Initial Local Anesthetic Dose With Continuous Interscalene Analgesia

Primary Purpose

Post-operative Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Ropivacaine

About this trial

This is an interventional treatment trial for Post-operative Pain focused on measuring Peripheral Nerve Infusion,, continuous brachial plexus block,, post-operative pain, diaphragmatic paresis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

William Beaumont Hospital
William Beaumont Hospitals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Arm Description

Initial Bolus 5 ml Ropivacaine

Initial Bolus 10 ml Ropivacaine

Initial Bolus 20 ml Ropivacaine

Outcomes

Primary Outcome Measures

Pain Measurements Via Numeric Pain Rating Scales (NRS)

Pain was reported via NRS ranging from 0 (no pain) to 10 (worst pain imaginable)

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.

Secondary Outcome Measures

Percentage of Participants Who Considered the Analgesic Technique "Helpful" or "Extremely Helpful"

Participants were asked to rate the helpfulness of their infusion: extremely harmful harmful neutral not harmful, but not helpful helpful extremely helpful

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.

Full Information

NCT ID

NCT00672100

First Posted

May 2, 2008

Last Updated

January 23, 2017

Sponsor

William Beaumont Hospitals

Collaborators

Beaumont Foundation of America

1. Study Identification

Unique Protocol Identification Number

NCT00672100

Brief Title

Initial Local Anesthetic Dose With Continuous Interscalene Analgesia

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 Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

February 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

William Beaumont Hospitals

Collaborators

Beaumont Foundation of America

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-operative Pain

Keywords

Peripheral Nerve Infusion,, continuous brachial plexus block,, post-operative pain, diaphragmatic paresis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Initial Bolus 5 ml Ropivacaine

Arm Title

Arm Type

Active Comparator

Arm Description

Initial Bolus 10 ml Ropivacaine

Arm Title

Arm Type

Active Comparator

Arm Description

Initial Bolus 20 ml Ropivacaine

Intervention Type

Drug

Intervention Name(s)

Ropivacaine

Intervention Description

Initial Bolus 5 ml Ropivacaine via interscalene injection

Intervention Type

Drug

Intervention Name(s)

Ropivacaine

Intervention Description

Initial Bolus 10 ml Ropivacaine via interscalene injection

Intervention Type

Drug

Intervention Name(s)

Ropivacaine

Intervention Description

Initial Bolus 20 ml Ropivacaine via interscalene injection

Primary Outcome Measure Information:

Title

Pain Measurements Via Numeric Pain Rating Scales (NRS)

Description

Pain was reported via NRS ranging from 0 (no pain) to 10 (worst pain imaginable)

Time Frame

Discharge, 24 h, 48h, 12 weeks

Title

Change in Diaphragmatic Displacement From Baseline to Post-surgery

Description

Time Frame

Baseline, Post anesthesia care unit (PACU) - within 8 hours

Secondary Outcome Measure Information:

Title

Percentage of Participants Who Considered the Analgesic Technique "Helpful" or "Extremely Helpful"

Description

Participants were asked to rate the helpfulness of their infusion: extremely harmful harmful neutral not harmful, but not helpful helpful extremely helpful

Time Frame

at 24 and 48 hours after discharge from the hospital

Title

Functional Outcome - Simple Shoulder Test (SST)

Description

Time Frame

Baseline, 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Craig Hartrick, MD

Organizational Affiliation

William Beaumont Hospitals

Official's Role

Principal Investigator

Facility Information:

Facility Name

William Beaumont Hospital

City

Royal Oak

State/Province

Michigan

ZIP/Postal Code

48073

Country

United States

Facility Name

William Beaumont Hospitals

City

Troy

State/Province

Michigan

ZIP/Postal Code

48085

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22443231

Citation

Hartrick CT, Tang YS, Siwek D, Murray R, Hunstad D, Smith G. The effect of initial local anesthetic dose with continuous interscalene analgesia on postoperative pain and diaphragmatic function in patients undergoing arthroscopic shoulder surgery: a double-blind, randomized controlled trial. BMC Anesthesiol. 2012 Mar 23;12:6. doi: 10.1186/1471-2253-12-6.

Results Reference

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Initial Local Anesthetic Dose With Continuous Interscalene Analgesia

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