Postoperative PainNCT03538847
Postoperative Pain After Vitreoretinal Surgery
An observational study of Postoperative Pain and Retinal Detachment, run by University of Florence.
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" . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Retinal Detachment
- What is being tested?
- Numerical rating scale
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing vitreoretinal surgery under locoregional or general anesthesia
Who may be able to join
- Vitreoretinal surgery
Who cannot join
- ASA IV
About this study
Official title: Postoperative Pain After Vitreo-retinal Surgery is Influenced by Duration of Surgery and Anaesthesia Conduction: a 1-year Retrospective Study.
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.
Read the 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.
- Conditions
- Postoperative Pain, Retinal Detachment
- Being tested
- Numerical rating scale
- Keywords
- postoperative pain, eye surgery, vitrectomy, pain control protocol
- Medical subject headings
- Pain, Postoperative, Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Numerical rating scaleOther
Measure of postoperative pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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 )
Measured: first day following surgery
Secondary outcomes (6)
age
years
Measured: day of surgery
duration of surgery
minutes
Measured: day of surgery
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)
Measured: day of surgery
comorbidities
presence
Measured: day of surgery
type of anesthesia
general anesthesia
Measured: day of surgery
type of anesthesia
locoregional anesthesia
Measured: day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start1 Jan 2016
- Primary completion1 Jan 2017
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Chiara Adembri, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538847
- Sponsor's protocol ID
- POP in VRS
- Status last verified
- May 2018
- First submitted
- 4 May 2018
- Last updated
- 29 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12652225Lesin 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.
PubMed 26858525Ip 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.
PubMed 19672167
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain After Vitreo-retinal Surgery is Influenced by Duration of Surgery and Anaesthesia Conduction: a 1-year Retrospective Study.
- ClinicalTrials.gov ID
- NCT03538847
- Acronym / sponsor ID
- POP in VRS
- Conditions
- Postoperative Pain, Retinal Detachment
- Keywords
- postoperative pain, eye surgery, vitrectomy, pain control protocol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 29 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing vitreoretinal surgery under locoregional or general anesthesia
Key inclusion criteria (1 listed)
- Vitreoretinal surgery
Key exclusion criteria (1 listed)
- ASA IV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Numerical rating scaleMeasure of postoperative pain | Other | – |
Primary outcome
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 )
6 secondary outcomes
age
Time frame: day of surgery
duration of surgery
Time frame: day of surgery
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
comorbidities
Time frame: day of surgery
type of anesthesia
Time frame: day of surgery
type of anesthesia
Time frame: day of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2018.
- Background: PubMed 12652225Fekrat 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.
- Background: PubMed 26858525Lesin 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.
- Background: PubMed 19672167Ip 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain and Retinal Detachment, run by University of Florence.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain (time frame: first day following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03538847, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2018.