Diaphragm ParalysisNCT01429584
The Effect of Interscalene Peripheral Nerve Block With 0.25% Bupivacaine vs 0.125% Bupivacaine on Lung Function
A study testing interscalene nerve block with 0.25% bupivacaine and interscalene block with 0.125% bupivacaine in people with Diaphragm Paralysis, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diaphragm Paralysis
- What is being tested?
- interscalene nerve block with 0.25% bupivacaine and interscalene block with 0.125% bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Feb 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients presenting for outpatient rotator cuff repair
- adults
- English as the primary language
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Orthopaedics Center
Salt Lake City, Utah, 84108
About this study
Official title: Investigation Into the Effect of 0.25% Bupivacaine for Interscalene Peripheral Nerve Block vs 0.125% Bupivacaine on Pulmonary Function
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.
Read the 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.
- Conditions
- Diaphragm Paralysis
- Being tested
- interscalene nerve block with 0.25% bupivacaine, interscalene block with 0.125% bupivacaine
- Keywords
- bupivacaine concentration, interscalene nerve block, diaphragm function, diaphragm weakness
- Medical subject headings
- Respiratory Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interscalene nerve block with 0.25% bupivacaineDrug
interscalene nerve block performed with 20 ml of 0.25% bupivacaine
interscalene block with 0.125% bupivacaineDrug
interscalene block with 20 ml of 0.125% bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| 0.25% bupivacaine | Active comparator | interscalene nerve block with 0.25% bupivacaine Receives: Drug: interscalene block with 0.125% bupivacaine |
| 0.125% bupivacaine | Active comparator | interscalene nerve block with 0.125% bupivacaine Receives: Drug: interscalene nerve block with 0.25% bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At discharge from the post-anesthesia care unit, within 5 hours of the completion of surgery
Secondary outcomes (2)
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.
Measured: At discharge from the post-anesthesia care unit, 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.
Measured: Within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2011 (estimated)
- Study startMay 2008
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diaphragm ParalysisStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Thackeray, University of Utah
- Investigators
- Elizabeth Thackeray, MD, MPH, Principal investigator, University of UtahJeffrey Swenson, MD, Study director, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01429584
- Sponsor's protocol ID
- 00026846
- Status last verified
- Dec 2013
- First submitted
- 27 Aug 2011
- Last updated
- 19 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation Into the Effect of 0.25% Bupivacaine for Interscalene Peripheral Nerve Block vs 0.125% Bupivacaine on Pulmonary Function
- ClinicalTrials.gov ID
- NCT01429584
- Acronym / sponsor ID
- 00026846
- Conditions
- Diaphragm Paralysis
- Keywords
- bupivacaine concentration, interscalene nerve block, diaphragm function, diaphragm weakness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 7 Sep 2011 (estimated)
- Results
- Posted 19 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.25% bupivacaine | Active comparator | Drug: interscalene block with 0.125% bupivacaineinterscalene nerve block with 0.25% bupivacaine |
| 0.125% bupivacaine | Active comparator | Drug: interscalene nerve block with 0.25% bupivacaineinterscalene nerve block with 0.125% bupivacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients presenting for outpatient rotator cuff repair
- adults
- English as the primary language
Key exclusion criteria (6 listed)
- evidence of peripheral nerve damage on affected side
- refusal of peripheral nerve block
- pregnant women
- lung disease, including obstructive sleep apnea
- chronic opioid use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interscalene nerve block with 0.25% bupivacaineinterscalene nerve block performed with 20 ml of 0.25% bupivacaine | Drug | 0.125% bupivacaine |
| interscalene block with 0.125% bupivacaineinterscalene block with 20 ml of 0.125% bupivacaine | Drug | 0.25% bupivacaine |
Primary outcome
Abnormal Lung Function
Time frame: At discharge from the post-anesthesia care unit, within 5 hours of the completion of surgery
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.
2 secondary outcomes
Pain Relief
Time frame: At discharge from the post-anesthesia care unit, within 5 hours of the completion of surgery
Satisfaction With Pain Control
Time frame: Within 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Diaphragm Paralysis
Not yet recruiting
Impact of High Thoracic Paravertebral Block on Diaphragmatic Function: a Prospective Study
Breast Cancer Surgery, Breast Cancer Surgery Pain
Recruiting
Evaluation of Diaphragmatic Function After Interscalene Block With Liposomal Bupivacaine
Diaphragmatic Function, Metacarpal Fracture
Not yet recruitingPhase 4
Comparative Evaluation of Diaphragmatic Function Following Interscalene, Anterior Suprascapular, and Costoclavicular Nerve Blocks in Shoulder Surgery
Hemidiaphragmatic Paralysis, Postoperative Pain
Recruiting
Diaphragmatic Evaluation by Fluoroscopy to Identify Phrenic Nerve Dysfunction Related to Electroporation
Atrial Fibrillation
Enrolling by invitation
Transcutaneous Diaphragmatic Electrical Stimulation and Pulmonary Function in Non-Ambulatory Cerebral Palsy
Cerebral Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Thackeray, MD, MPH principal investigator
University of Utah
Jeffrey Swenson, MD study director
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interscalene nerve block with 0.25% bupivacaine and interscalene block with 0.125% bupivacaine in people with Diaphragm Paralysis, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abnormal Lung Function (time frame: At discharge from the post-anesthesia care unit, within 5 hours of the completion of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2013.