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

December 12, 2017 updated by: NYU Langone Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

117

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Transnasal SPG block
Procedure: Transnasal SPG block

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2015

Primary Completion (ACTUAL)

December 12, 2017

Study Completion (ACTUAL)

December 12, 2017

Study Registration Dates

First Submitted

January 21, 2016

First Submitted That Met QC Criteria

January 27, 2016

First Posted (ESTIMATE)

February 1, 2016

Study Record Updates

Last Update Posted (ACTUAL)

December 14, 2017

Last Update Submitted That Met QC Criteria

December 12, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-00619

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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