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Completed

NCT Number: NCT02733393

Sphenopalatine Ganglion Block to Treat Shoulder Pain After Thoracotomy

The purpose of this pilot study is to evaluate the utility of sphenopalatine ganglion (SPG) block to manage ipsilateral shoulder pain (ISP) after thoracotomy. This will be an open label preliminary pilot study to determine if SPG block has potential utility to manage ISP in post-thoracotomy patients. The primary outcome variable will be reduction of shoulder pain.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

New York University Langone Medical Center

New York, 10016, United States

About this study

This is an open label preliminary pilot study which will evaluate the utility of sphenopalatine ganglion (SPG) block to manage ipsilateral shoulder pain (ISP). It will determine if SPG block has potential utility to manage ISP in post-thoracotomy patients One hundred (100) patients will initially be consented in this study. Patients have to develop ISP and have a pain VAS >= 5. The study is seeking ten (10) eligible participants.

Patients will be followed after the SPG block(s), and the duration of pain relief will be monitored by serial assessments of the VAS. This assessment will occur for the initial SPG block and for all follow-up blocks, if performed. The follow-up assessments will only involve having the patient rate the ISP using a verbal VAS; This will take less than a minute of patients time. In addition, all patients will have PRN access to standard systemic analgesics as routinely ordered by the surgical service Safety assessments will be performed on all subjects. Blood pressure, heart rate and respiratory rate will be obtained every 15 minutes after each SPG block for 90 minutes. Dr. Grant will monitor the subjects for 90 minutes after each SPG block.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Any type of open thoracotomy or video-assisted thoracoscopic surgery (VATS)
  • Presence of post-operative ISP, VAS>5/10
  • American Society of Anesthesiologists Class 1 - 4
  • No allergy to lidocaine

Exclusion criteria

  • American Society of Anesthesiologists Class 5
  • Allergy to lidocaine
  • Nasal pathology (e.g., deviated septum)
  • Bleeding diathesis
  • Any patient who the PI feels will be unable to comply with all protocol related procedures
  • Shoulder pain prior to thoracotomy

Treatment and study plan

Sphenopalatine Ganglion (SPG) Block

Procedure

Patients who are undergoing a thoracotomy will be informed that they may develop moderate to severe postoperative ISP and may have the option to receive an SPG block. The SPG block will be performed every three minutes for 20 minutes, 0.1mL of the 4% lidocaine will be administered through. After 20 minutes and various intervals thereafter the patient will be asked to rate their shoulder pain.

Lidocaine

Drug

Primary outcomes

  1. Shoulder Pain Reduction

    Time frame: 90 Minutes

    Patients will be followed after the SPG block(s) and the duration of pain relief will be monitored by serial assessments of the VAS. This assessment will occur for the initial SPG block and for all follow-up blocks, if performed.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Sphenopalatine Ganglion Block to Treat Shoulder Pain After Thoracotomy- An Open Label Pilot Study

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 11, 2016
Registry last updated
Oct 2, 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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