NCT03538847

Brief Summary

Postoperative pain (POP) is frequently underestimated in general and little data are available particularly for POP after vitreoretinal surgery (VRS). The investigators will conduct a 1-year retrospective study on patients undergoing VRS at "Careggi Hospital" . The aim of the study will be to observe the amount of POP, its time course, factors associated with its appearance and finally the efficacy of the pain protocol that is in use.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

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

January 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 29, 2018

Completed
Last Updated

May 29, 2018

Status Verified

May 1, 2018

Enrollment Period

1 year

First QC Date

May 4, 2018

Last Update Submit

May 24, 2018

Conditions

Keywords

postoperative paineye surgeryvitrectomypain control protocol

Outcome Measures

Primary Outcomes (1)

  • postoperative pain

    Numerical Rating Scale (NRS, a verbal numerical scale ranging from 0 to10, with 0 indicating no pain and 10 the maximal possible pain )

    first day following surgery

Secondary Outcomes (6)

  • age

    day of surgery

  • duration of surgery

    day of surgery

  • ASA (American Society of Anesthesiologists) PHYSICAL STATUS CLASSIFICATION SYSTEM I-IV (with I indicating a normal healthy patient and IV a patient with severe systemic disease that is a constant threat to life)

    day of surgery

  • comorbidities

    day of surgery

  • type of anesthesia

    day of surgery

  • +1 more secondary outcomes

Interventions

Measure of postoperative pain

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing vitreoretinal surgery under locoregional or general anesthesia

You may qualify if:

  • Vitreoretinal surgery

You may not qualify if:

  • ASA IV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Fekrat S, Marsh MJ, Elsing SH, Raja SC, de Juan E Jr, Campochiaro PA, Haller JA. Intraoperative ketorolac and eye pain after viteoretinal surgery: a prospective, randomized, placebo-controlled study. Retina. 2003 Feb;23(1):8-13. doi: 10.1097/00006982-200302000-00002.

    PMID: 12652225BACKGROUND
  • Lesin M, Dzaja Lozo M, Duplancic-Sundov Z, Dzaja I, Davidovic N, Banozic A, Puljak L. Risk factors associated with postoperative pain after ophthalmic surgery: a prospective study. Ther Clin Risk Manag. 2016 Jan 22;12:93-102. doi: 10.2147/TCRM.S97024. eCollection 2016.

    PMID: 26858525BACKGROUND
  • Ip HY, Abrishami A, Peng PW, Wong J, Chung F. Predictors of postoperative pain and analgesic consumption: a qualitative systematic review. Anesthesiology. 2009 Sep;111(3):657-77. doi: 10.1097/ALN.0b013e3181aae87a.

    PMID: 19672167BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeRetinal Detachment

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsRetinal DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 4, 2018

First Posted

May 29, 2018

Study Start

January 1, 2016

Primary Completion

January 1, 2017

Study Completion

February 1, 2017

Last Updated

May 29, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share