Sphenopalatine Ganglion Block to Treat Shoulder Pain Duri... | NCT02670057

Studies
Sphenopalatine Ganglion Block to Treat Shoulder Pain During and/or After Cesarean

NCT02670057

Sponsor

NYU Langone Health

Status

Completed

Last Update Posted

Dec 14, 2017Actual

Enrollment

117Actual

Phase

Not Applicable

Conditions

Ipsilateral Shoulder Pain

Interventions

Transnasal SPG block

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2015Actual

Primary Completion Date

Dec 12, 2017Actual

Completion Date

Dec 12, 2017Actual

First Submitted Date

Jan 21, 2016

First Submission Date that Met QC Criteria

Jan 27, 2016

First Posted Date

Feb 1, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2017

Last Update Posted Date

Dec 14, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

117Actual

Label	Type	Description	Intervention Names
Transnasal SPG block	Experimental		Procedure: Transnasal SPG block

Name	Type	Description	Arm Group Labels	Other Names
Transnasal SPG block	Procedure		Transnasal SPG block

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction of shoulder pain measured using Verbal Analog pain Scale (VAS)		90 Minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cesarean
Presence of post-operative ISP, VAS >5/10
American Society of Anesthesiologists Class 1 - 3.
No allergy to lidocaine

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gilbert Grant	New York University Medical School	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New York University School of Medicine		New York	New York	10016	United States