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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elizabeth Thackeray, University of Utah
ClinicalTrials.gov Identifier:
NCT01429584
First received: August 27, 2011
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Diaphragm Paralysis
Drug: interscalene nerve block with 0.25% bupivacaine
Drug: interscalene block with 0.125% bupivacaine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigation Into the Effect of 0.25% Bupivacaine for Interscalene Peripheral Nerve Block vs 0.125% Bupivacaine on Pulmonary Function

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Abnormal Lung Function [ Time Frame: At discharge from the post-anesthesia care unit, within 5 hours of the completion of surgery ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: At discharge from the post-anesthesia care unit, within 5 hours of the completion of surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: Within 30 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 30
Study Start Date: May 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 0.25% bupivacaine
interscalene nerve block with 0.25% bupivacaine
Drug: interscalene block with 0.125% bupivacaine
interscalene block with 20 ml of 0.125% bupivacaine
Active Comparator: 0.125% bupivacaine
interscalene nerve block with 0.125% bupivacaine
Drug: interscalene nerve block with 0.25% bupivacaine
interscalene nerve block performed with 20 ml of 0.25% 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01429584

Locations
United States, Utah
University of Utah Orthopaedics Center
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Elizabeth Thackeray, MD, MPH University of Utah
Study Director: Jeffrey Swenson, MD University of Utah
  More Information

No publications provided

Responsible Party: Elizabeth Thackeray, Assistant Professor of Anesthesiology, University of Utah
ClinicalTrials.gov Identifier: NCT01429584     History of Changes
Other Study ID Numbers: 00026846
Study First Received: August 27, 2011
Results First Received: June 16, 2012
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
bupivacaine concentration
interscalene nerve block
diaphragm function
diaphragm weakness

Additional relevant MeSH terms:
Respiratory Paralysis
Nervous System Diseases
Neurologic Manifestations
Paralysis
Respiration Disorders
Respiratory Insufficiency
Respiratory Tract Diseases
Signs and Symptoms
Bupivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014