The Effect of Interscalene Peripheral Nerve Block With 0.25% Bupivacaine vs 0.125% Bupivacaine on Lung Function
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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 |
| 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 |
- 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 room air oxygen saturation. Both 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.
- 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. Pain scores 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.
| 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 nerve block
interscalene nerve block performed with 20 ml of either 0.25% or 0.125% bupivacaine
|
|
Active Comparator: 0.125% bupivacaine
interscalene nerve block with 0.125% bupivacaine
|
Drug: interscalene nerve block
interscalene nerve block performed with 20 ml of either 0.25% 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 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 |
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| United States, Utah | |
| University of Utah Orthopaedics Center | |
| Salt Lake City, Utah, United States, 84108 | |
| 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: | 0.25% vs 0.125% bupivacaine |
| Study First Received: | August 27, 2011 |
| Last Updated: | September 6, 2011 |
| 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 Paralysis Respiratory Insufficiency Respiration Disorders Respiratory Tract Diseases Neurologic Manifestations Nervous System Diseases Signs and Symptoms Bupivacaine |
Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013