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

Primary Purpose

Diaphragm Paralysis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
interscalene nerve block with 0.25% bupivacaine
interscalene block with 0.125% bupivacaine
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diaphragm Paralysis focused on measuring bupivacaine concentration, interscalene nerve block, diaphragm function, diaphragm weakness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Utah Orthopaedics Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

0.25% bupivacaine

0.125% bupivacaine

Arm Description

interscalene nerve block with 0.25% bupivacaine

interscalene nerve block with 0.125% bupivacaine

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pain Relief
Pain relief was assessed by recording the amount of opioid administered intraoperatively and in the PACU. The Visual Analogue Score of pain scores (0-10, with 0 being no pain and 10 being the worst pain imaginable) were recorded at the time of discharge from the PACU, within 5 hours of the completion of surgery.
Satisfaction With Pain Control
A follow-up phone call was made to patients within 30 days of surgery to assess the presence of any complications related to the block and overall satisfaction with pain control. Overall satisfaction was assessed on a 7-point Likert scale of 1-not at all satisfied with pain control 2-mostly unsatisfied with pain control 3-slightly unsatisfied with pain control 4-no opinion 5-slightly satisfied with pain control 6-mostly satisfied with pain control 7-completely satisfied with pain control.

Full Information

First Posted
August 27, 2011
Last Updated
December 9, 2013
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT01429584
Brief Title
The Effect of Interscalene Peripheral Nerve Block With 0.25% Bupivacaine vs 0.125% Bupivacaine on Lung Function
Official Title
Investigation Into the Effect of 0.25% Bupivacaine for Interscalene Peripheral Nerve Block vs 0.125% Bupivacaine on Pulmonary Function
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Prior to placement of interscalene brachial plexus peripheral nerve block (ISPNB), diaphragm function was assessed using ultrasound as normal, no movement, or paradoxical. Room air pulse oximetry (SpO2) was recorded. Patients were randomized to receive either 0.25% bupivacaine or 0.125% bupivacaine. ISPNB was performed using a coded syringe of the study drug, so that the anesthesiologists performing the nerve block, the patient, and the nurses assessing the patient were blinded as to the concentration. Patients were given a general endotracheal anesthesia for rotator cuff repair, and opioids were administered at the discretion of the attending anesthesiologist. When patients met criteria for PACU discharge, diaphragm function was again assessed using ultrasound and room air SpO2 was recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diaphragm Paralysis
Keywords
bupivacaine concentration, interscalene nerve block, diaphragm function, diaphragm weakness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.25% bupivacaine
Arm Type
Active Comparator
Arm Description
interscalene nerve block with 0.25% bupivacaine
Arm Title
0.125% bupivacaine
Arm Type
Active Comparator
Arm Description
interscalene nerve block with 0.125% bupivacaine
Intervention Type
Drug
Intervention Name(s)
interscalene nerve block with 0.25% bupivacaine
Intervention Description
interscalene nerve block performed with 20 ml of 0.25% bupivacaine
Intervention Type
Drug
Intervention Name(s)
interscalene block with 0.125% bupivacaine
Intervention Description
interscalene block with 20 ml of 0.125% bupivacaine
Primary Outcome Measure Information:
Title
Abnormal Lung Function
Description
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.
Time Frame
At discharge from the post-anesthesia care unit, within 5 hours of the completion of surgery
Secondary Outcome Measure Information:
Title
Pain Relief
Description
Pain relief was assessed by recording the amount of opioid administered intraoperatively and in the PACU. The Visual Analogue Score of pain scores (0-10, with 0 being no pain and 10 being the worst pain imaginable) were recorded at the time of discharge from the PACU, within 5 hours of the completion of surgery.
Time Frame
At discharge from the post-anesthesia care unit, within 5 hours of the completion of surgery
Title
Satisfaction With Pain Control
Description
A follow-up phone call was made to patients within 30 days of surgery to assess the presence of any complications related to the block and overall satisfaction with pain control. Overall satisfaction was assessed on a 7-point Likert scale of 1-not at all satisfied with pain control 2-mostly unsatisfied with pain control 3-slightly unsatisfied with pain control 4-no opinion 5-slightly satisfied with pain control 6-mostly satisfied with pain control 7-completely satisfied with pain control.
Time Frame
Within 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients presenting for outpatient rotator cuff repair adults English as the primary language Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Thackeray, MD, MPH
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey Swenson, MD
Organizational Affiliation
University of Utah
Official's Role
Study Director
Facility Information:
Facility Name
University of Utah Orthopaedics Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States

12. IPD Sharing Statement

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

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