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

Primary Purpose

Ipsilateral Shoulder Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Transnasal SPG block

About this trial

This is an interventional treatment trial for Ipsilateral Shoulder Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

New York University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transnasal SPG block

Arm Description

Outcomes

Primary Outcome Measures

Reduction of shoulder pain measured using Verbal Analog pain Scale (VAS)

Secondary Outcome Measures

Full Information

NCT ID

NCT02670057

First Posted

January 21, 2016

Last Updated

December 12, 2017

Sponsor

NYU Langone Health

1. Study Identification

Unique Protocol Identification Number

NCT02670057

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

November 2015 (Actual)

Primary Completion Date

December 12, 2017 (Actual)

Study Completion Date

December 12, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ipsilateral Shoulder Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

117 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Transnasal SPG block

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Transnasal SPG block

Primary Outcome Measure Information:

Title

Reduction of shoulder pain measured using Verbal Analog pain Scale (VAS)

Time Frame

90 Minutes

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gilbert Grant

Organizational Affiliation

New York University Medical School

Official's Role

Principal Investigator

Facility Information:

Facility Name

New York University School of Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

12. IPD Sharing Statement

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

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