Sphenopalatine Ganglion Block to Treat Shoulder Pain After Thoracotomy

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02733393

Enrollment

Registered

2016-04-11

Start date

2015-09-30

Completion date

2017-09-05

Last updated

2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ipsilateral Shoulder Pain

Keywords

Thoracotomy, Postoperative, Lidocaine, Sphenopalatine Ganglion Block

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.

Interventions

PROCEDURESphenopalatine 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.

DRUGlidocaine

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026