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Sphenopalatine Ganglion Block to Treat Shoulder Pain After Thoracotomy

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ClinicalTrials.gov Identifier: NCT02733393
Recruitment Status : Completed
First Posted : April 11, 2016
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ipsilateral Shoulder Pain Procedure: Sphenopalatine Ganglion (SPG) Block Drug: lidocaine Phase 1

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 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 After Thoracotomy- An Open Label Pilot Study
Study Start Date : September 2015
Actual Primary Completion Date : September 5, 2017
Actual Study Completion Date : September 5, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SPG Block Procedure: Sphenopalatine Ganglion (SPG) Block
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.

Drug: lidocaine



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02733393


Locations
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United States, New York
New York University Langone Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Gilbert Grant, MD NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02733393    
Other Study ID Numbers: 15-00618
First Posted: April 11, 2016    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by NYU Langone Health:
Thoracotomy
Postoperative
Lidocaine
Sphenopalatine Ganglion Block
Additional relevant MeSH terms:
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Ganglion Cysts
Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action