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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02670057
Recruitment Status : Completed
First Posted : February 1, 2016
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
Ipsilateral Shoulder Pain Procedure: Transnasal SPG block Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sphenopalatine Ganglion Block to Treat Shoulder Pain During and/or After Cesarean
Actual Study Start Date : November 2015
Actual Primary Completion Date : December 12, 2017
Actual Study Completion Date : December 12, 2017

Arm Intervention/treatment
Experimental: Transnasal SPG block Procedure: Transnasal SPG block



Primary Outcome Measures :
  1. Reduction of shoulder pain measured using Verbal Analog pain Scale (VAS) [ Time Frame: 90 Minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670057


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Gilbert Grant New York University Medical School
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02670057    
Other Study ID Numbers: 15-00619
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms