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Completed

NCT Number: NCT03538847

Postoperative Pain After Vitreoretinal Surgery

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Vitreoretinal surgery

Exclusion criteria

  • ASA IV

Treatment and study plan

numerical rating scale

Other

Measure of postoperative pain

Primary outcomes

  1. postoperative pain

    Time frame: 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 outcomes

  1. age

    Time frame: day of surgery

    years

  2. duration of surgery

    Time frame: day of surgery

    minutes

  3. 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)

    Time frame: day of surgery

    I-IV (I : healthy patient; IV: worse state of health)

  4. comorbidities

    Time frame: day of surgery

    presence

  5. type of anesthesia

    Time frame: day of surgery

    general anesthesia

  6. type of anesthesia

    Time frame: day of surgery

    locoregional anesthesia

Sponsors and collaborators

Lead sponsor

University of Florence

Other

Registry information

Official study title

Postoperative Pain After Vitreo-retinal Surgery is Influenced by Duration of Surgery and Anaesthesia Conduction: a 1-year Retrospective Study.

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 29, 2018
Registry last updated
May 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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