The Effect of Interscalene Peripheral Nerve Block With 0.25% Bupivacaine vs 0.125% Bupivacaine on Lung Function

NCT01429584 | Completed Results

• 1 other identifier: 00026846
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Peripheral nerve blocks are used to provide post-operative pain relief. Nerve blocks in the neck, in the interscalene area, provide pain relief after shoulder surgery but can cause temporary weakness or paralysis of the diaphragm. The investigators hypothesized that a lower concentration of bupivacaine would cause less weakness of the diaphragm but still provide good pain relief. Lung function and pain control was studied after interscalene peripheral nerve block with 20 milliliters of 0.25% bupivacaine or 0.125% bupivacaine.

Conditions

Diaphragm Paralysis

Keywords

bupivacaine concentration; interscalene nerve block; diaphragm function; diaphragm weakness

Outcome Measures

Primary Outcomes (1)

• Abnormal Lung Function

  Lung function was evaluated by examining diaphragm movement using ultrasound imaging and change in room air oxygen saturation (SpO2). Diaphragm movement was assessed using ultrasound as Normal (diaphragm moves caudad with inspiration), Abnormal (diaphragm does not move caudad with inspiration), and Paradoxical (diaphragm moves cephalad with inspiration). Both diaphragm function and room air SpO2 were assessed prior to any intervention to establish a baseline, and again on discharge from the PACU, within 5 hours of the completion of surgery.

  At discharge from the post-anesthesia care unit, within 5 hours of the completion of surgery

Secondary Outcomes (2)

• Pain Relief

  At discharge from the post-anesthesia care unit, within 5 hours of the completion of surgery

• Satisfaction With Pain Control

  Within 30 days

Study Arms (2)

0.25% bupivacaine

ACTIVE COMPARATOR

interscalene nerve block with 0.25% bupivacaine

Drug: interscalene block with 0.125% bupivacaine

0.125% bupivacaine

ACTIVE COMPARATOR

interscalene nerve block with 0.125% bupivacaine

Drug: interscalene nerve block with 0.25% bupivacaine

Interventions

interscalene nerve block with 0.25% bupivacaine DRUG

interscalene nerve block performed with 20 ml of 0.25% bupivacaine

0.125% bupivacaine

interscalene block with 0.125% bupivacaine DRUG

interscalene block with 20 ml of 0.125% bupivacaine

0.25% bupivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients presenting for outpatient rotator cuff repair
• adults
• English as the primary language

You may not qualify if:

• evidence of peripheral nerve damage on affected side
• refusal of peripheral nerve block
• pregnant women
• lung disease, including obstructive sleep apnea
• chronic opioid use
• mental handicap

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Orthopaedics Center

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Respiratory Paralysis

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Elizabeth Thackeray
• Organization: University of Utah Department of Anesthesiology

elizabeth.thackeray@hsc.utah.edu

(801) 581-6393

Study Officials

• Elizabeth Thackeray, MD, MPH

  University of Utah

  PRINCIPAL INVESTIGATOR

• Jeffrey Swenson, MD

  University of Utah

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: August 27, 2011
• First Posted: September 7, 2011
• Study Start: May 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: December 19, 2013
• Results First Posted: December 19, 2013

Record last verified: 2013-12

Locations

US (1)