Postoperative Pain After Vitreoretinal Surgery

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03538847
• Other study ID #: POP in VRS
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: February 1, 2017

Study information

• Verified date: May 2018
• Source: University of Florence
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: February 1, 2017
• Est. primary completion date: January 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Vitreoretinal surgery

Exclusion Criteria:

• ASA IV

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Retinal Detachment

Intervention

Other:
• Numerical rating scale
Measure of postoperative pain

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Florence

References & 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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	age	years	day of surgery
Secondary	duration of surgery	minutes	day of surgery
Secondary	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)	I-IV (I : healthy patient; IV: worse state of health)	day of surgery
Secondary	comorbidities	presence	day of surgery
Secondary	type of anesthesia	general anesthesia	day of surgery
Secondary	type of anesthesia	locoregional anesthesia	day of surgery