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

NCT ID: NCT02670057

Last Updated: 2017-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-12-12

Brief Summary

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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

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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

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Ipsilateral Shoulder Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transnasal SPG block

Group Type EXPERIMENTAL

Transnasal SPG block

Intervention Type PROCEDURE

Interventions

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Transnasal SPG block

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilbert Grant

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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15-00619

Identifier Type: -

Identifier Source: org_study_id