Ipsilateral Shoulder PainPhase 1NCT02733393
Sphenopalatine Ganglion Block to Treat Shoulder Pain After Thoracotomy
A Phase 1 study testing Sphenopalatine Ganglion (SPG) Block and lidocaine in people with Ipsilateral Shoulder Pain, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this pilot study is to evaluate the utility of sphenopalatine ganglion (SPG) block to manage ipsilateral shoulder pain (ISP) after thoracotomy. This will be an open label preliminary pilot study to determine if SPG block has potential utility to manage ISP in post-thoracotomy patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ipsilateral Shoulder Pain
- What is being tested?
- Sphenopalatine Ganglion (SPG) Block and lidocaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to 5 Sep 2017
- Phase
- Phase 1
- 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
- Any type of open thoracotomy or video-assisted thoracoscopic surgery (VATS)
- Presence of post-operative ISP, VAS>5/10
- American Society of Anesthesiologists Class 1 - 4
- No allergy to lidocaine
Who cannot join
- American Society of Anesthesiologists Class 5
- Allergy to lidocaine
- Nasal pathology (e.g., deviated septum)
- Bleeding diathesis
- Any patient who the PI feels will be unable to comply with all protocol related procedures
- Shoulder pain prior to thoracotomy
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University Langone Medical Center
New York, New York, 10016
About this study
Official title: Sphenopalatine Ganglion Block to Treat Shoulder Pain After Thoracotomy- An Open Label Pilot Study
The purpose of this pilot study is to evaluate the utility of sphenopalatine ganglion (SPG) block to manage ipsilateral shoulder pain (ISP) after thoracotomy. This will be an open label preliminary pilot study to determine if SPG block has potential utility to manage ISP in post-thoracotomy patients. The primary outcome variable will be reduction of shoulder pain.
Read the detailed description
This is an open label preliminary pilot study which will evaluate the utility of sphenopalatine ganglion (SPG) block to manage ipsilateral shoulder pain (ISP). It will determine if SPG block has potential utility to manage ISP in post-thoracotomy patients One hundred (100) patients will initially be consented in this study. Patients have to develop ISP and have a pain VAS >= 5. The study is seeking ten (10) eligible participants.
Patients will be followed after the SPG block(s), and the duration of pain relief will be monitored by serial assessments of the VAS. This assessment will occur for the initial SPG block and for all follow-up blocks, if performed. The follow-up assessments will only involve having the patient rate the ISP using a verbal VAS; This will take less than a minute of patients time. In addition, all patients will have PRN access to standard systemic analgesics as routinely ordered by the surgical service Safety assessments will be performed on all subjects. Blood pressure, heart rate and respiratory rate will be obtained every 15 minutes after each SPG block for 90 minutes. Dr. Grant will monitor the subjects for 90 minutes after each SPG block.
- Conditions
- Ipsilateral Shoulder Pain
- Being tested
- Sphenopalatine Ganglion (SPG) Block, lidocaine
- Keywords
- Thoracotomy, Postoperative, Lidocaine, Sphenopalatine Ganglion Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sphenopalatine Ganglion (SPG) BlockProcedure or surgery
Patients who are undergoing a thoracotomy will be informed that they may develop moderate to severe postoperative ISP and may have the option to receive an SPG block. The SPG block will be performed every three minutes for 20 minutes, 0.1mL of the 4% lidocaine will be administered through. After 20 minutes and various intervals thereafter the patient will be asked to rate their shoulder pain.
lidocaineDrug
| Study group | Role | What they receive |
|---|---|---|
| SPG Block | Experimental | Not described Receives: Procedure: Sphenopalatine Ganglion (SPG) Block; Drug: lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain Reduction
Patients will be followed after the SPG block(s) and the duration of pain relief will be monitored by serial assessments of the VAS. This assessment will occur for the initial SPG block and for all follow-up blocks, if performed.
Measured: 90 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study startSep 2015
- Primary completion5 Sep 2017
- Study completion5 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ipsilateral Shoulder PainStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilbert Grant, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733393
- Sponsor's protocol ID
- 15-00618
- Status last verified
- Sep 2017
- First submitted
- 5 Apr 2016
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sphenopalatine Ganglion Block to Treat Shoulder Pain After Thoracotomy- An Open Label Pilot Study
- ClinicalTrials.gov ID
- NCT02733393
- Acronym / sponsor ID
- 15-00618
- Conditions
- Ipsilateral Shoulder Pain
- Keywords
- Thoracotomy, Postoperative, Lidocaine, Sphenopalatine Ganglion Block
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- 5 Sep 2017 (actual)
- Study completion
- 5 Sep 2017 (actual)
- First posted
- 11 Apr 2016 (estimated)
- 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.
The purpose of this pilot study is to evaluate the utility of sphenopalatine ganglion (SPG) block to manage ipsilateral shoulder pain (ISP) after thoracotomy. This will be an open label preliminary pilot study to determine if SPG block has potential utility to manage ISP in post-thoracotomy patients. The primary outcome variable will be reduction of shoulder pain.
Detailed description
This is an open label preliminary pilot study which will evaluate the utility of sphenopalatine ganglion (SPG) block to manage ipsilateral shoulder pain (ISP). It will determine if SPG block has potential utility to manage ISP in post-thoracotomy patients One hundred (100) patients will initially be consented in this study. Patients have to develop ISP and have a pain VAS >= 5. The study is seeking ten (10) eligible participants.
Patients will be followed after the SPG block(s), and the duration of pain relief will be monitored by serial assessments of the VAS. This assessment will occur for the initial SPG block and for all follow-up blocks, if performed. The follow-up assessments will only involve having the patient rate the ISP using a verbal VAS; This will take less than a minute of patients time. In addition, all patients will have PRN access to standard systemic analgesics as routinely ordered by the surgical service Safety assessments will be performed on all subjects. Blood pressure, heart rate and respiratory rate will be obtained every 15 minutes after each SPG block for 90 minutes. Dr. Grant will monitor the subjects for 90 minutes after each SPG block.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPG Block | Experimental | Procedure: Sphenopalatine Ganglion (SPG) Block, Drug: lidocaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Any type of open thoracotomy or video-assisted thoracoscopic surgery (VATS)
- Presence of post-operative ISP, VAS>5/10
- American Society of Anesthesiologists Class 1 - 4
- No allergy to lidocaine
Key exclusion criteria (6 listed)
- American Society of Anesthesiologists Class 5
- Allergy to lidocaine
- Nasal pathology (e.g., deviated septum)
- Bleeding diathesis
- Any patient who the PI feels will be unable to comply with all protocol related procedures
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 |
|---|---|---|
| Sphenopalatine Ganglion (SPG) BlockPatients who are undergoing a thoracotomy will be informed that they may develop moderate to severe postoperative ISP and may have the option to receive an SPG block. The SPG block will be performed every three minutes for 20 minutes, 0.1mL of the 4% lidocaine will be administered through. After 20 minutes and various intervals thereafter the patient will be asked to rate their shoulder pain. | Procedure or surgery | SPG Block |
| lidocaine | Drug | SPG Block |
Primary outcome
Shoulder Pain Reduction
Time frame: 90 Minutes
Patients will be followed after the SPG block(s) and the duration of pain relief will be monitored by serial assessments of the VAS. This assessment will occur for the initial SPG block and for all follow-up blocks, if performed.
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 Oct 2017.
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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.
Gilbert Grant, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sphenopalatine Ganglion (SPG) Block and lidocaine in people with Ipsilateral Shoulder Pain, run by NYU Langone Health 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 4 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 2 Oct 2017. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Shoulder Pain Reduction (time frame: 90 Minutes). 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 2 Oct 2017.