Ipsilateral Shoulder PainNCT02670057
Sphenopalatine Ganglion Block to Treat Shoulder Pain During and/or After Cesarean
A study testing Transnasal SPG block in people with Ipsilateral Shoulder Pain, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this open label pilot study is to evaluate the utility of sphenopalatine ganglion (SPG) block to manage ipsilateral shoulder pain (ISP) during and/or after cesarean. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ipsilateral Shoulder Pain
- What is being tested?
- Transnasal SPG block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 12 Dec 2017
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cesarean
- Presence of post-operative ISP, VAS >5/10
- American Society of Anesthesiologists Class 1 - 3.
- No allergy to lidocaine
Who cannot join
- American Society of Anesthesiologists Class 4 or 5.
- Allergy to lidocaine
- Nasal pathology (e.g., deviated septum)
- Patients who receive sedatives during cesarean
- Bleeding diathesis
- Any patient who the PI feels will be unable to comply with all protocol related procedures
- Shoulder pain prior to cesarean
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
The purpose of this open label pilot study is to evaluate the utility of sphenopalatine ganglion (SPG) block to manage ipsilateral shoulder pain (ISP) during and/or after cesarean.
Read the detailed description
Shoulder pain thought to be caused by blood and amniotic fluid irritation of the diaphragm and nerves that supply the shoulder, can occur during and/or after a cesarean. Investigators will consent 100 patients, and will enroll 10 patients who develop ISP and have a score of is >5/10 on the Verbal Analog pain Scale (VAS). Patients will be their own controls. Transnasal SPG block will be performed after childbirth, and and beginning at 20 minutes post treatment, the patient will be asked to rate their shoulder pain using the VAS a number of times.
- Conditions
- Ipsilateral Shoulder Pain
- Being tested
- Transnasal SPG block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transnasal SPG blockProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Transnasal SPG block | Experimental | Not described Receives: Procedure: Transnasal SPG block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of shoulder pain measured using Verbal Analog pain Scale (VAS)
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 posted1 Feb 2016 (estimated)
- Study startNov 2015
- Primary completion12 Dec 2017
- Study completion12 Dec 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilbert Grant, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670057
- Sponsor's protocol ID
- 15-00619
- Status last verified
- Dec 2017
- First submitted
- 21 Jan 2016
- Last updated
- 14 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sphenopalatine Ganglion Block to Treat Shoulder Pain During and/or After Cesarean
- ClinicalTrials.gov ID
- NCT02670057
- Acronym / sponsor ID
- 15-00619
- Conditions
- Ipsilateral Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- 12 Dec 2017 (actual)
- Study completion
- 12 Dec 2017 (actual)
- First posted
- 1 Feb 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 open label pilot study is to evaluate the utility of sphenopalatine ganglion (SPG) block to manage ipsilateral shoulder pain (ISP) during and/or after cesarean.
Detailed description
Shoulder pain thought to be caused by blood and amniotic fluid irritation of the diaphragm and nerves that supply the shoulder, can occur during and/or after a cesarean. Investigators will consent 100 patients, and will enroll 10 patients who develop ISP and have a score of is >5/10 on the Verbal Analog pain Scale (VAS). Patients will be their own controls. Transnasal SPG block will be performed after childbirth, and and beginning at 20 minutes post treatment, the patient will be asked to rate their shoulder pain using the VAS a number of times.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transnasal SPG block | Experimental | Procedure: Transnasal SPG block |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cesarean
- Presence of post-operative ISP, VAS >5/10
- American Society of Anesthesiologists Class 1 - 3.
- No allergy to lidocaine
Key exclusion criteria (7 listed)
- American Society of Anesthesiologists Class 4 or 5.
- Allergy to lidocaine
- Nasal pathology (e.g., deviated septum)
- Patients who receive sedatives during cesarean
- Bleeding diathesis
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 |
|---|---|---|
| Transnasal SPG block | Procedure or surgery | Transnasal SPG block |
Primary outcome
Reduction of shoulder pain measured using Verbal Analog pain Scale (VAS)
Time frame: 90 Minutes
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 14 Dec 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 principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transnasal SPG block 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 7 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 14 Dec 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.
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?
Reduction of shoulder pain measured using Verbal Analog pain Scale (VAS) (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 14 Dec 2017.