NCT03252301

Brief Summary

The trial will estimate post-operative pain management in elective surgical patients using the PMD-200 device. The device measures physiological parameters by placing a non-invasive sensor on a fingertip and displays an objective pain level in a 0-100 scale. The pain level will be estimated before surgery (baseline), after surgery and during administration of parenteral analgesia. Treatment and analgesia will be given according to clinical considerations and standard ward protocols. The device measurements won't influence the treatment.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

August 11, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 17, 2017

Completed
15 days until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

August 21, 2017

Status Verified

August 1, 2017

Enrollment Period

10 months

First QC Date

August 11, 2017

Last Update Submit

August 16, 2017

Conditions

Pain, Postoperative

Keywords

painpost operativesurgeryobjective

Outcome Measures

Primary Outcomes (1)

  • pain level estimation by 1-100 scale by non invasive finger sensor

    a finger sensor will estimate the pain by a numerical scale of 1-100 in which 1 stand for no pain and 100 stand for severe pain.

    up to 7 months

Interventions

PMD 200DEVICE

finger sensor which estimate objectively the pain level

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-100
  • Elective patient for laparoscopic cholecystectomy
  • Absence of acute or chronic pain

You may not qualify if:

  • Pregnancy
  • Dementia and mental retardation
  • Drugs that influence the autonomic system as beta blocker
  • Arrhythmia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, PostoperativePain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • haim Paran, MD

    clalit

    STUDY CHAIR

Central Study Contacts

Guy Elad, MD

CONTACT

972543977953dr.guyelad@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 11, 2017

First Posted

August 17, 2017

Study Start

September 1, 2017

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

August 21, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share