Initial Local Anesthetic Dose With Continuous Interscalene Analgesia

Post-operative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00672100
• Other study ID #: HIC 2007-198
• Status: Completed
• Phase: N/A
• First received: May 2, 2008
• Last updated: May 22, 2013
• Start date: January 2009
• Est. completion date: August 2010

Study information

• Verified date: May 2013
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: William Beaumont Research Institute Human Investigation Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain

Intervention

Drug:
• Ropivacaine
Initial Bolus 5 ml Ropivacaine via interscalene injection
• Ropivacaine
Initial Bolus 10 ml Ropivacaine via interscalene injection
• Ropivacaine
Initial Bolus 20 ml Ropivacaine via interscalene injection

Locations

Country	Name	City	State
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	William Beaumont Hospitals	Troy	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
William Beaumont Hospitals	Beaumont Foundation of America

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Measurements Via Numeric Pain Rating Scales (NRS)	Pain was reported via NRS ranging from 0 (no pain) to 10 (worst pain imaginable)	Discharge, 24 h, 48h, 12 weeks	No
Primary	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.	Baseline, Post anesthesia care unit (PACU) - within 8 hours	Yes
Secondary	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	at 24 and 48 hours after discharge from the hospital	No
Secondary	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.	Baseline, 12 weeks	No