Postoperative Pain After Vitreoretinal Surgery

NCT ID: NCT03538847

Last Updated: 2018-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2017-02-01

Brief Summary

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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.

Detailed Description

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Post-operative pain (POP) is frequently underestimated, mostly after eye surgery, a type of surgery in which trauma is limited and pain is not investigated as patients are often discharged from the hospital within a few hours. Good POP management can improve clinical outcome and patients' satisfaction and constitutes essential criteria for hospital discharge after day-case or ambulatory surgery. 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" , a teaching University Hospital in Italy. The aim of the study will be to observe the amount of POP after VRS, its time course, factors associated with its appearance and finally the efficacy of the pain protocol that is in use.

Pain will be evaluated according to the "Numerical Rating Scale" (NRS), a 11-point numeric scale ranging from '0' which represents "no pain" and '10' which represents extreme pain at several intervals after surgery. Analgesic consumption (in terms of type and amount of analgesics) and the efficacy of the analgesic protocol in use will also be recorded.

Factors possibly associated with POP (such as duration of surgery, presence of comorbidities, ASA physical status, age, type of anesthesia (locoregional or general anesthesia)) will be analyzed.

The associations between the principal outcome (amount of POP) and risk factors will be evaluated using a simple and multiple logistic regression model.

Conditions

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Postoperative Pain Retinal Detachment

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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Numerical rating scale

Measure of postoperative pain

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Vitreoretinal surgery

Exclusion Criteria

* ASA IV
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florence

OTHER

Sponsor Role lead

Responsible Party

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Dr. Chiara Adembri

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 12652225 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26858525 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19672167 (View on PubMed)

Other Identifiers

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POP in VRS

Identifier Type: -

Identifier Source: org_study_id

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