Initial Local Anesthetic Dose With Continuous Interscalene Analgesia

NCT ID: NCT00672100

Last Updated: 2017-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-08-31

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.

Conditions

Post-operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

A

Initial Bolus 5 ml Ropivacaine

Group Type: ACTIVE_COMPARATOR

Ropivacaine

Intervention Type: DRUG

Initial Bolus 5 ml Ropivacaine via interscalene injection

B

Initial Bolus 10 ml Ropivacaine

Group Type: ACTIVE_COMPARATOR

Ropivacaine

Intervention Type: DRUG

Initial Bolus 10 ml Ropivacaine via interscalene injection

C

Initial Bolus 20 ml Ropivacaine

Group Type: ACTIVE_COMPARATOR

Ropivacaine

Intervention Type: DRUG

Initial Bolus 20 ml Ropivacaine via interscalene injection

Interventions

Ropivacaine

Initial Bolus 5 ml Ropivacaine via interscalene injection

Intervention Type: DRUG

Ropivacaine

Initial Bolus 10 ml Ropivacaine via interscalene injection

Intervention Type: DRUG

Ropivacaine

Initial Bolus 20 ml Ropivacaine via interscalene injection

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beaumont Foundation of America

OTHER

Sponsor Role: collaborator

William Beaumont Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Craig Hartrick, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Locations

William Beaumont Hospital

Royal Oak, Michigan, United States

William Beaumont Hospitals

Troy, Michigan, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 22443231 (View on PubMed)

Other Identifiers

HIC 2007-198

Identifier Type: -

Identifier Source: org_study_id