NCT02733393

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 11, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2017

Completed
Last Updated

October 2, 2017

Status Verified

September 1, 2017

Enrollment Period

2 years

First QC Date

April 5, 2016

Last Update Submit

September 28, 2017

Conditions

Ipsilateral Shoulder Pain

Keywords

ThoracotomyPostoperativeLidocaineSphenopalatine Ganglion Block

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

SPG Block

EXPERIMENTAL
Procedure: Sphenopalatine Ganglion (SPG) BlockDrug: lidocaine

Interventions

Sphenopalatine Ganglion (SPG) BlockPROCEDURE

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.

SPG Block
lidocaineDRUG
SPG Block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

spirogermaniumDental OcclusionLidocaine

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Gilbert Grant, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2016

First Posted

April 11, 2016

Study Start

September 1, 2015

Primary Completion

September 5, 2017

Study Completion

September 5, 2017

Last Updated

October 2, 2017

Record last verified: 2017-09

Locations

US(1)