Postoperative Pain After Vitreoretinal Surgery

Completed

• Conditions: Postoperative Pain; Retinal Detachment

• Registration Number: NCT03538847
• Lead Sponsor: University of Florence

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.

Detailed 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 Timeline

• Study Start: 2016-01-01
• Primary Completion: 2017-01-01
• Study Completion: 2017-02-01
• Status Verified: 2018-05
• Study First Submitted: 2018-05-04
• Study First Submitted QC: 2018-05-24
• Last Update Submitted: 2018-05-24
• Study First Posted: 2018-05-29
• Last Update Posted: 2018-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• Vitreoretinal surgery

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Exclusion Criteria

• ASA IV

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
postoperative pain	first day following surgery	Numerical Rating Scale (NRS, a verbal numerical scale ranging from 0 to10, with 0 indicating no pain and 10 the maximal possible pain )

Secondary Outcome Measures

Name	Time	Method
age	day of surgery	years
duration of surgery	day of surgery	minutes
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	I-IV (I : healthy patient; IV: worse state of health)
comorbidities	day of surgery	presence
type of anesthesia	day of surgery	locoregional anesthesia