Initial Local Anesthetic Dose With Continuous Interscalene Analgesia

NCT00672100 | Completed Results

• 1 other identifier: HIC 2007-198
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

Post-operative Pain

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

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

  at 24 and 48 hours after discharge from the hospital

• Functional Outcome - Simple Shoulder Test (SST)

  Baseline, 12 weeks

Study Arms (3)

A

ACTIVE COMPARATOR

Initial Bolus 5 ml Ropivacaine

Drug: Ropivacaine

B

ACTIVE COMPARATOR

Initial Bolus 10 ml Ropivacaine

Drug: Ropivacaine

C

ACTIVE COMPARATOR

Initial Bolus 20 ml Ropivacaine

Drug: Ropivacaine

Interventions

Ropivacaine DRUG

Initial Bolus 5 ml Ropivacaine via interscalene injection

A

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corewell Health East: lead
• Beaumont Foundation of America: collaborator

Study Sites (2)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

William Beaumont Hospitals

Troy, Michigan, 48085, United States

Location

Related 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-blind, randomized controlled trial. BMC Anesthesiol. 2012 Mar 23;12:6. doi: 10.1186/1471-2253-12-6.

  PMID: 22443231 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Craig T. Hartrick, MD
• Organization: William Beaumont Hospital

chartrick@beaumont.edu

248-964-3440

Study Officials

• Craig Hartrick, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2008
• First Posted: May 6, 2008
• Study Start: January 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: August 1, 2010
• Last Updated: March 7, 2017
• Results First Posted: May 23, 2013

Record last verified: 2013-05

Locations

US (2)