Sphenopalatine Ganglion Block to Treat Shoulder Pain After Thoracotomy

Phase 1

Completed

• Conditions: Ipsilateral Shoulder Pain
• Interventions: Procedure: Sphenopalatine Ganglion (SPG) Block; Drug: lidocaine

• Registration Number: NCT02733393
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2016-04-05
• Study First Submitted QC: 2016-04-08
• Study First Posted: 2016-04-11
• Status Verified: 2017-09
• Primary Completion: 2017-09-05
• Study Completion: 2017-09-05
• Last Update Submitted: 2017-09-28
• Last Update Posted: 2017-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SPG Block	Sphenopalatine Ganglion (SPG) Block	-
SPG Block	lidocaine	-

Primary Outcome Measures

Name	Time	Method
Shoulder Pain Reduction	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.

Trial Locations

Locations (1)

New York University Langone Medical Center; 🇺🇸 New York, New York, United States