Postoperative Pain After Vitreoretinal Surgery

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03538847
Study type	Observational
Source	University of Florence
Contact
Status	Completed
Phase
Start date	January 1, 2016
Completion date	February 1, 2017

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.