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Sphenopalatine Ganglion Block to Treat Shoulder Pain After Thoracotomy

Primary Purpose

Ipsilateral Shoulder Pain

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sphenopalatine Ganglion (SPG) Block
lidocaine
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ipsilateral Shoulder Pain focused on measuring Thoracotomy, Postoperative, Lidocaine, Sphenopalatine Ganglion Block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York University Langone Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SPG Block

Arm Description

Outcomes

Primary Outcome Measures

Shoulder Pain Reduction
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.

Secondary Outcome Measures

Full Information

First Posted
April 5, 2016
Last Updated
September 28, 2017
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT02733393
Brief Title
Sphenopalatine Ganglion Block to Treat Shoulder Pain After Thoracotomy
Official Title
Sphenopalatine Ganglion Block to Treat Shoulder Pain After Thoracotomy- An Open Label Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
September 5, 2017 (Actual)
Study Completion Date
September 5, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ipsilateral Shoulder Pain
Keywords
Thoracotomy, Postoperative, Lidocaine, Sphenopalatine Ganglion Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPG Block
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Sphenopalatine Ganglion (SPG) Block
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
lidocaine
Primary Outcome Measure Information:
Title
Shoulder Pain Reduction
Description
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.
Time Frame
90 Minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilbert Grant, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

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Sphenopalatine Ganglion Block to Treat Shoulder Pain After Thoracotomy

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