Clinical trial NCT00672100: 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
Overall status: COMPLETED
Phase: NA
Conditions: Post-operative Pain
Keywords: Peripheral Nerve Infusion,
continuous brachial plexus block,
post-operative pain
diaphragmatic paresis
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
Collaborators: name: Beaumont Foundation of America
First posted: 2008-05-06
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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 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.

Primary outcomes:
measure: Pain Measurements Via Numeric Pain Rating Scales (NRS)
timeFrame: Discharge, 24 h, 48h, 12 weeks
measure: Change in Diaphragmatic Displacement From Baseline to Post-surgery
timeFrame: Baseline, Post anesthesia care unit (PACU) - within 8 hours
Secondary outcomes:
measure: Percentage of Participants Who Considered the Analgesic Technique "Helpful" or "Extremely Helpful"
timeFrame: at 24 and 48 hours after discharge from the hospital
measure: Functional Outcome - Simple Shoulder Test (SST)
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Troy
country: United States
facility: William Beaumont Hospitals
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Craig Hartrick, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.