NCT02670057

Brief Summary

The purpose of this open label pilot study is to evaluate the utility of sphenopalatine ganglion (SPG) block to manage ipsilateral shoulder pain (ISP) during and/or after cesarean.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2017

Completed
Last Updated

December 14, 2017

Status Verified

December 1, 2017

Enrollment Period

2.1 years

First QC Date

January 21, 2016

Last Update Submit

December 12, 2017

Conditions

Ipsilateral Shoulder Pain

Outcome Measures

Primary Outcomes (1)

  • Reduction of shoulder pain measured using Verbal Analog pain Scale (VAS)

    90 Minutes

Study Arms (1)

Transnasal SPG block

EXPERIMENTAL
Procedure: Transnasal SPG block

Interventions

Transnasal SPG blockPROCEDURE
Transnasal SPG block

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cesarean
  • Presence of post-operative ISP, VAS \>5/10
  • American Society of Anesthesiologists Class 1 - 3.
  • No allergy to lidocaine

You may not qualify if:

  • American Society of Anesthesiologists Class 4 or 5.
  • Allergy to lidocaine
  • Nasal pathology (e.g., deviated septum)
  • Patients who receive sedatives during cesarean
  • Bleeding diathesis
  • Any patient who the PI feels will be unable to comply with all protocol related procedures
  • Shoulder pain prior to cesarean

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Study Officials

  • Gilbert Grant

    New York University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2016

First Posted

February 1, 2016

Study Start

November 1, 2015

Primary Completion

December 12, 2017

Study Completion

December 12, 2017

Last Updated

December 14, 2017

Record last verified: 2017-12

Locations

US(1)