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

Ipsilateral Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02670057
• Other study ID #: 15-00619
• Status: Completed
• Phase: N/A
• First received: January 21, 2016
• Last updated: December 12, 2017
• Start date: November 2015
• Est. completion date: December 12, 2017

Study information

• Verified date: December 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: December 12, 2017
• Est. primary completion date: December 12, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ipsilateral Shoulder Pain
• Shoulder Pain

Intervention

Procedure:
• Transnasal SPG block

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of shoulder pain measured using Verbal Analog pain Scale (VAS)		90 Minutes