Sphenopalatine Ganglion Block to Treat Shoulder Pain After Thoracotomy

Ipsilateral Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02733393
• Other study ID #: 15-00618
• Status: Completed
• Phase: Phase 1
• First received: April 5, 2016
• Last updated: September 28, 2017
• Start date: September 2015
• Est. completion date: September 5, 2017

Study information

• Verified date: September 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: September 5, 2017
• Est. primary completion date: September 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ganglion Cysts
• Ipsilateral Shoulder Pain
• Shoulder Pain

Intervention

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

Locations

Country	Name	City	State
United States	New York University Langone Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	90 Minutes