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

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

Sponsors

Lead Sponsor: NYU Langone Health

Source 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.

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.

Overall Status Completed
Start Date November 2015
Completion Date December 12, 2017
Primary Completion Date December 12, 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Reduction of shoulder pain measured using Verbal Analog pain Scale (VAS) 90 Minutes
Enrollment 117
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Transnasal SPG block

Arm Group Label: Transnasal SPG block

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

Gender: Female

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Gilbert Grant Principal Investigator New York University Medical School
Location
Facility: New York University School of Medicine
Location Countries

United States

Verification Date

December 2017

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Transnasal SPG block

Type: Experimental

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov