Anesthesia, LocalNCT03677778
Interscalene Brachial Plexus Block Washout to Reverse Inadvertent Phrenic Nerve Blockade
A study testing Normal saline injected via interscalene nerve catheter in people with Anesthesia, Local and Phrenic Nerve Paralysis, run by Stanford University at 1 site in United States.
Trial summary
One of the most frequently performed peripheral nerve blocks (the injection of local anesthetic near nerves to block sensation/ movement to a specific part of the body) is the interscalene brachial plexus block for upper extremity surgeries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Local, Phrenic Nerve Paralysis, Upper Extremity Injury
- What is being tested?
- Normal saline injected via interscalene nerve catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2018to 7 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients (18 years and over) scheduled for surgery requiring a continuous interscalene brachial plexus nerve block catheter as part of their anesthetic care.
Who cannot join
- Concomitant life-threatening injuries and other concomitant injuries causing significant pain
- Pregnant
- Any condition impairing patient's ability to consent to participation in study, and an existing condition contraindicating a nerve block, i.e. nerve injury, existing bleeding disorder, infection in the vicinity of the block, and patient refusal.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Health Care (SHC)
Palo Alto, California, 94304
About this study
One of the most frequently performed peripheral nerve blocks (the injection of local anesthetic near nerves to block sensation/ movement to a specific part of the body) is the interscalene brachial plexus block for upper extremity surgeries. This type of block can unmask underlying respiratory issues such as shortness of breath due to a well-known and typically insignificant side effect of temporary diaphragmatic paralysis.
The nerve block may be able to use saline solution to wash out the local anesthetic and potentially reverse this respiratory side effect. Specifically, the goal of this study is to determine if the injection of saline through the nerve block catheter reverses blockade of the phrenic nerve supplying the diaphragm, without affecting the ability of the nerve block to provide pain control after surgery.
- Conditions
- Anesthesia, Local, Phrenic Nerve Paralysis, Upper Extremity Injury, Phrenic Nerve Palsy on the Left, Phrenic Nerve Palsy on the Right
- Being tested
- Normal saline injected via interscalene nerve catheter, Placebo
- Medical subject headings
- Arm Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal saline injected via interscalene nerve catheterProcedure or surgery
With the catheter covered, treatment group patients will receive a normal saline (NS) bolus regimen (30cc 0.9% NS) via their interscalene nerve block catheter.
PlaceboOther
With the catheter covered, placebo group patients will go through the same steps as the treatment group, but no solution will be injected into the interscalene nerve block catheter.
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | After surgery, in the post-operative recovery room, patients randomized to both the intervention and control groups will have 10cc 0.5% ropivacaine bolused via their nerve catheters. After 30 minutes, the following will be measured/assessed: spirometry data, pain scores (using the Numeric Rating Scale), and, if time is sufficient, bilateral diaphragmatic excursion via ultrasonography and brachial plexus motor and sensory exams. This control group will have no normal saline injected into their nerve catheter (no intervention). Then, both the control and treatment groups will have the following measured/assessed after 5, 15 and 30 minutes: spirometry data, pain scores (using the Numeric Rating Scale), and, if time is sufficient, bilateral diaphragmatic excursion via ultrasonography and brachial plexus motor and sensory exams. Investigators will be blinded to whether the patient is in the intervention or treatment group. Receives: Other: Placebo |
| Treatment group | Active comparator | After surgery, in the post-operative recovery room, patients randomized to both the intervention and control groups will have 10cc 0.5% ropivacaine bolused via their nerve catheters. After 30 minutes, the following will be measured/assessed: spirometry data, pain scores (using the Numeric Rating Scale), and, if time is sufficient, bilateral diaphragmatic excursion via ultrasonography and brachial plexus motor and sensory exams. This group will then have 30ml of normal saline injected into their nerve catheter. Then, both the control and treatment groups will have the following measured/assessed after 5, 15 and 30 minutes: spirometry data, pain scores (using the Numeric Rating Scale), and, if time is sufficient, bilateral diaphragmatic excursion via ultrasonography and brachial plexus motor and sensory exams. Investigators will be blinded to whether the patient is in the intervention or treatment group. Receives: Procedure: Normal saline injected via interscalene nerve catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in forced vital capacity (FVC)
Spirometry data will be collected using a digital spirometer before nerve block is placed, after surgery, and after receiving either the placebo or treatment.
Measured: Before the nerve block placement, within 1 hour after the surgery, then in 5, 15, and 30 minutes after the saline injection/placebo (1 minute each for a total of 5 assessments)
Change in peak expiratory flow (PEF)
Spirometry data will be collected using a digital spirometer before nerve block is placed, after surgery, and after receiving either the placebo or treatment.
Measured: Before the nerve block placement, within 1 hour after the surgery, then in 5, 15, and 30 minutes after the saline injection/placebo (1 minute each for a total of 5 assessments)
Change in forced expiratory volume in 1 second (FEV1)
Spirometry data will be collected using a digital spirometer before nerve block is placed, after surgery, and after receiving either the placebo or treatment.
Measured: Before the nerve block placement, within 1 hour after the surgery, then in 5, 15, and 30 minutes after the saline injection/placebo (1 minute each for a total of 5 assessments)
Secondary outcomes (3)
Diaphragmatic excursion
Diaphragmatic excursion will be assessed via ultrasound before nerve block is placed, after surgery, and while receiving either the placebo or treatment.
Measured: Before nerve block is placed, within 1 hour after the surgery, and while receiving either the placebo or treatment (5 minutes each for a total of 3 assessments.)
Brachial plexus sensory and motor exam
Brachial plexus sensory and motor exam changes will be assessed before nerve block is placed, after surgery, and while receiving either the placebo or treatment.
Measured: Before nerve block is placed, within 1 hour after the surgery, and while receiving either the placebo or treatment (2 minutes each for a total of 3 assessments).
Pain scores
The Numerical Pain Rating Scale is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). Pain scores will be assessed before nerve block is placed, after surgery, while receiving either the placebo or treatment.
Measured: Pain scores will be assessed before nerve block is placed, within 1 hour after the surgery, while receiving either the placebo or treatment. (1 minute each for a total of 3 assessments)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start22 Oct 2018
- Primary completion7 Jul 2022
- Study completion7 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi-Ho Ban Tsui, Stanford University
- Investigators
- Ban Tsui, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03677778
- Sponsor's protocol ID
- 46830
- Status last verified
- Jul 2022
- First submitted
- 18 Sep 2018
- Last updated
- 2 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. doi: 10.1213/00000539-199104000-00014.
PubMed 2006740Urmey WF, McDonald M. Hemidiaphragmatic paresis during interscalene brachial plexus block: effects on pulmonary function and chest wall mechanics. Anesth Analg. 1992 Mar;74(3):352-7. doi: 10.1213/00000539-199203000-00006.
PubMed 1539813Lenters TR, Davies J, Matsen FA 3rd. The types and severity of complications associated with interscalene brachial plexus block anesthesia: local and national evidence. J Shoulder Elbow Surg. 2007 Jul-Aug;16(4):379-87. doi: 10.1016/j.jse.2006.10.007. Epub 2007 Apr 19.
PubMed 17448698Zink W, Graf BM. Local anesthetic myotoxicity. Reg Anesth Pain Med. 2004 Jul-Aug;29(4):333-40. doi: 10.1016/j.rapm.2004.02.008.
PubMed 15305253Katircioglu K, Ozkalkanli MY, Kalfaoglu H, Sannav S, Ozgurbuz U, Savaci S. Reversal of prilocaine epidural anesthesia using epidural saline or ringer's lactate washout. Reg Anesth Pain Med. 2007 Sep-Oct;32(5):389-92. doi: 10.1016/j.rapm.2007.06.004.
PubMed 17961836Park EY, Kil HK, Park WS, Lee NH, Hong JY. Effect of epidural saline washout on regression of sensory and motor block after epidural anaesthesia with 2% lidocaine and fentanyl in elderly patients. Anaesthesia. 2009 Mar;64(3):273-6. doi: 10.1111/j.1365-2044.2008.05746.x.
PubMed 19302639Sitzman BT, DiFazio CA, Playfair PA, Stevens RA, Hanes CF, Herman TB, Yates HK, Leisure GS. Reversal of lidocaine with epinephrine epidural anesthesia using epidural saline washout. Reg Anesth Pain Med. 2001 May-Jun;26(3):246-51. doi: 10.1053/rapm.2001.22587.
PubMed 11359224Ip VH, Tsui BC. Continuous interscalene block: the good, the bad and the refined spread. Acta Anaesthesiol Scand. 2012 Apr;56(4):526-30. doi: 10.1111/j.1399-6576.2012.02650.x. Epub 2012 Feb 16.
PubMed 22338616Courtney KR, Kendig JJ, Cohen EN. Frequency-dependent conduction block: the role of nerve impulse pattern in local anesthetic potency. Anesthesiology. 1978 Feb;48(2):111-7. No abstract available.
PubMed 306789Gerber LN, Sun LY, Ma W, Basireddy S, Guo N, Costouros J, Cheung E, Boublik J, Horn JL, Tsui BC. Clinical effect of normal saline injectate into interscalene nerve block catheters given within one hour of local anesthetic bolus on analgesia and hemidiaphragmatic paralysis. Reg Anesth Pain Med. 2021 Feb;46(2):124-129. doi: 10.1136/rapm-2020-101922. Epub 2020 Nov 12.
PubMed 33184166
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interscalene Brachial Plexus Block Washout to Reverse Inadvertent Phrenic Nerve Blockade
- ClinicalTrials.gov ID
- NCT03677778
- Acronym / sponsor ID
- 46830
- Conditions
- Anesthesia, Local, Phrenic Nerve Paralysis, Upper Extremity Injury, Phrenic Nerve Palsy on the Left, Phrenic Nerve Palsy on the Right
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 19 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One of the most frequently performed peripheral nerve blocks (the injection of local anesthetic near nerves to block sensation/ movement to a specific part of the body) is the interscalene brachial plexus block for upper extremity surgeries. This type of block can unmask underlying respiratory issues such as shortness of breath due to a well-known and typically insignificant side effect of temporary diaphragmatic paralysis.
The nerve block may be able to use saline solution to wash out the local anesthetic and potentially reverse this respiratory side effect. Specifically, the goal of this study is to determine if the injection of saline through the nerve block catheter reverses blockade of the phrenic nerve supplying the diaphragm, without affecting the ability of the nerve block to provide pain control after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Other: PlaceboAfter surgery, in the post-operative recovery room, patients randomized to both the intervention and control groups will have 10cc 0.5% ropivacaine bolused via their nerve catheters. After 30 minutes, the following will be measured/assessed: spirometry data, pain scores (using the Numeric Rating Scale), and, if time is sufficient, bilateral diaphragmatic excursion via ultrasonography and brachial plexus motor and sensory exams. This control group will have no normal saline injected into their nerve catheter (no intervention). Then, both the control and treatment groups will have the following measured/assessed after 5, 15 and 30 minutes: spirometry data, pain scores (using the Numeric Rating Scale), and, if time is sufficient, bilateral diaphragmatic excursion via ultrasonography and brachial plexus motor and sensory exams. Investigators will be blinded to whether the patient is in the intervention or treatment group. |
| Treatment group | Active comparator | Procedure: Normal saline injected via interscalene nerve catheterAfter surgery, in the post-operative recovery room, patients randomized to both the intervention and control groups will have 10cc 0.5% ropivacaine bolused via their nerve catheters. After 30 minutes, the following will be measured/assessed: spirometry data, pain scores (using the Numeric Rating Scale), and, if time is sufficient, bilateral diaphragmatic excursion via ultrasonography and brachial plexus motor and sensory exams. This group will then have 30ml of normal saline injected into their nerve catheter. Then, both the control and treatment groups will have the following measured/assessed after 5, 15 and 30 minutes: spirometry data, pain scores (using the Numeric Rating Scale), and, if time is sufficient, bilateral diaphragmatic excursion via ultrasonography and brachial plexus motor and sensory exams. Investigators will be blinded to whether the patient is in the intervention or treatment group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients (18 years and over) scheduled for surgery requiring a continuous interscalene brachial plexus nerve block catheter as part of their anesthetic care.
Key exclusion criteria (3 listed)
- Concomitant life-threatening injuries and other concomitant injuries causing significant pain
- Pregnant
- Any condition impairing patient's ability to consent to participation in study, and an existing condition contraindicating a nerve block, i.e. nerve injury, existing bleeding disorder, infection in the vicinity of the block, and patient refusal.
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 |
|---|---|---|
| Normal saline injected via interscalene nerve catheterWith the catheter covered, treatment group patients will receive a normal saline (NS) bolus regimen (30cc 0.9% NS) via their interscalene nerve block catheter. | Procedure or surgery | Treatment group |
| PlaceboWith the catheter covered, placebo group patients will go through the same steps as the treatment group, but no solution will be injected into the interscalene nerve block catheter. | Other | Placebo group |
Primary outcome
Change in forced vital capacity (FVC)
Time frame: Before the nerve block placement, within 1 hour after the surgery, then in 5, 15, and 30 minutes after the saline injection/placebo (1 minute each for a total of 5 assessments)
Spirometry data will be collected using a digital spirometer before nerve block is placed, after surgery, and after receiving either the placebo or treatment.
Change in peak expiratory flow (PEF)
Time frame: Before the nerve block placement, within 1 hour after the surgery, then in 5, 15, and 30 minutes after the saline injection/placebo (1 minute each for a total of 5 assessments)
Spirometry data will be collected using a digital spirometer before nerve block is placed, after surgery, and after receiving either the placebo or treatment.
Change in forced expiratory volume in 1 second (FEV1)
Time frame: Before the nerve block placement, within 1 hour after the surgery, then in 5, 15, and 30 minutes after the saline injection/placebo (1 minute each for a total of 5 assessments)
Spirometry data will be collected using a digital spirometer before nerve block is placed, after surgery, and after receiving either the placebo or treatment.
3 secondary outcomes
Diaphragmatic excursion
Time frame: Before nerve block is placed, within 1 hour after the surgery, and while receiving either the placebo or treatment (5 minutes each for a total of 3 assessments.)
Brachial plexus sensory and motor exam
Time frame: Before nerve block is placed, within 1 hour after the surgery, and while receiving either the placebo or treatment (2 minutes each for a total of 3 assessments).
Pain scores
Time frame: Pain scores will be assessed before nerve block is placed, within 1 hour after the surgery, while receiving either the placebo or treatment. (1 minute each for a total of 3 assessments)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Background: PubMed 2006740Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. doi: 10.1213/00000539-199104000-00014.
- Background: PubMed 1539813Urmey WF, McDonald M. Hemidiaphragmatic paresis during interscalene brachial plexus block: effects on pulmonary function and chest wall mechanics. Anesth Analg. 1992 Mar;74(3):352-7. doi: 10.1213/00000539-199203000-00006.
- Background: PubMed 17448698Lenters TR, Davies J, Matsen FA 3rd. The types and severity of complications associated with interscalene brachial plexus block anesthesia: local and national evidence. J Shoulder Elbow Surg. 2007 Jul-Aug;16(4):379-87. doi: 10.1016/j.jse.2006.10.007. Epub 2007 Apr 19.
- Background: PubMed 15305253Zink W, Graf BM. Local anesthetic myotoxicity. Reg Anesth Pain Med. 2004 Jul-Aug;29(4):333-40. doi: 10.1016/j.rapm.2004.02.008.
- Background: PubMed 17961836Katircioglu K, Ozkalkanli MY, Kalfaoglu H, Sannav S, Ozgurbuz U, Savaci S. Reversal of prilocaine epidural anesthesia using epidural saline or ringer's lactate washout. Reg Anesth Pain Med. 2007 Sep-Oct;32(5):389-92. doi: 10.1016/j.rapm.2007.06.004.
- Background: PubMed 19302639Park EY, Kil HK, Park WS, Lee NH, Hong JY. Effect of epidural saline washout on regression of sensory and motor block after epidural anaesthesia with 2% lidocaine and fentanyl in elderly patients. Anaesthesia. 2009 Mar;64(3):273-6. doi: 10.1111/j.1365-2044.2008.05746.x.
- Background: PubMed 11359224Sitzman BT, DiFazio CA, Playfair PA, Stevens RA, Hanes CF, Herman TB, Yates HK, Leisure GS. Reversal of lidocaine with epinephrine epidural anesthesia using epidural saline washout. Reg Anesth Pain Med. 2001 May-Jun;26(3):246-51. doi: 10.1053/rapm.2001.22587.
- Background: PubMed 22338616Ip VH, Tsui BC. Continuous interscalene block: the good, the bad and the refined spread. Acta Anaesthesiol Scand. 2012 Apr;56(4):526-30. doi: 10.1111/j.1399-6576.2012.02650.x. Epub 2012 Feb 16.
- Background: PubMed 306789Courtney KR, Kendig JJ, Cohen EN. Frequency-dependent conduction block: the role of nerve impulse pattern in local anesthetic potency. Anesthesiology. 1978 Feb;48(2):111-7. No abstract available.
- Derived from this study: PubMed 33184166Gerber LN, Sun LY, Ma W, Basireddy S, Guo N, Costouros J, Cheung E, Boublik J, Horn JL, Tsui BC. Clinical effect of normal saline injectate into interscalene nerve block catheters given within one hour of local anesthetic bolus on analgesia and hemidiaphragmatic paralysis. Reg Anesth Pain Med. 2021 Feb;46(2):124-129. doi: 10.1136/rapm-2020-101922. Epub 2020 Nov 12.
- Individual participant dataSharing planned: No
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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.
Ban Tsui, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal saline injected via interscalene nerve catheter in people with Anesthesia, Local and Phrenic Nerve Paralysis, run by Stanford University 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 1 inclusion and 3 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 2 Aug 2022. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in forced vital capacity (FVC) (time frame: Before the nerve block placement, within 1 hour after the surgery, then in 5, 15, and 30 minutes after the saline injection/placebo (1 minute each for a total of 5 assessments)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03677778, which also lists 10 linked publications.
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 2 Aug 2022.