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OpenTrials
Completed

NCT Number: NCT02670057

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

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.

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Key information

Conditions

Ipsilateral Shoulder Pain

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transnasal SPG block

Procedure

Primary outcomes

  1. Reduction of shoulder pain measured using Verbal Analog pain Scale (VAS)

    Time frame: 90 Minutes

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 1, 2016
Registry last updated
Dec 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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