- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06673979
Risk Factors for Chronic Postoperative Pain After Elective Nephrectomy
Risk Factors Affecting Chronic Postoperative Pain After Elective Nephrectomy
Chronic postoperative pain (CPP) is typically defined as pain persisting for 3 months or more after surgery[1]. CPP is a common and increasingly prevalent morbidity, leading to long-term psychological issues, reduced quality of life, and impaired functionality[2]. To reduce the incidence of CPP, high-risk patients are identified, and various surgical techniques, pharmacological agents, and regional anesthesia techniques are employed[3].
The primary aim of our study is to scale chronic pain at 1 hour, 3 months, and 1 year post-nephrectomy using the Numeric Rating Scale (NRS), ranging from 0 to 10. The secondary aim is to evaluate the effects of factors influencing chronic postoperative pain on the NRS scores.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Istanbul, Turkey (Türkiye)
- Istanbul University-Cerrahpasa
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria: -Patients aged 18-90 years,
- ASA I-IV,
- undergoing elective nephrectomy under general anesthesia will be included in the study.
Exclusion Criteria:
- Patients who cannot be reached by phone and hose who die within the 1-year postoperative period will be excluded from the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Painfull: patients with Numeric Rating Score equal or higher than 4
The patients are asked to rate their pain according to the Numeric Rating Scale (0=no pain; 10=worse possible pain), and patients with NRS equal or higher than 4 are defined as "painfull".
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The patients are asked to rate their pain according to the Numeric Rating Scale (0=no pain; 10=worse possible pain).
|
|
Pain-free: patients with Numeric Rating Score lower than 4
The patients are asked to rate their pain according to the Numeric Rating Scale (0=no pain; 10=worse possible pain), and patients with NRS lower than 4 are defined as "pain-free".
|
The patients are asked to rate their pain according to the Numeric Rating Scale (0=no pain; 10=worse possible pain).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NRS 1 hour
Time Frame: 1 hour after the end of the surgery
|
The patients are asked to rate their pain according to the Numeric Rating Scale (0=no pain; 10=worse possible pain).
Patients with NRS equal or higher than 4 are defined as painfull; and, patients with NRS lower than 4 are defined as pain-free
|
1 hour after the end of the surgery
|
|
NRS 3 months
Time Frame: 3 months after the surgery
|
The patients are asked to rate their pain according to the Numeric Rating Scale (0=no pain; 10=worse possible pain).
Patients with NRS equal or higher than 4 are defined as painfull; and, patients with NRS lower than 4 are defined as pain-free
|
3 months after the surgery
|
|
NRS 1 year
Time Frame: 1 year after the surgery
|
The patients are asked to rate their pain according to the Numeric Rating Scale (0=no pain; 10=worse possible pain).
Patients with NRS equal or higher than 4 are defined as painfull; and, patients with NRS lower than 4 are defined as pain-free
|
1 year after the surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
age
Time Frame: At the time of preoperative assesment
|
Age of the patiens as years
|
At the time of preoperative assesment
|
|
height
Time Frame: At the time of preoperative assesment
|
Height of the patiens as meter
|
At the time of preoperative assesment
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|
BMI
Time Frame: At the time of preoperative assesment
|
body mass index of the patiens as kg/m2
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At the time of preoperative assesment
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smoking
Time Frame: At the time of preoperative assesment
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Data of the patient if they are smoking or not
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At the time of preoperative assesment
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Amount of opioid and non-opioid analgesics used perioperatively
Time Frame: At the time of perioperative assesment
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Amount of opioid and non-opioid analgesics used perioperatively
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At the time of perioperative assesment
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|
Gender
Time Frame: At the time of preoperative assesment
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Woman or man
|
At the time of preoperative assesment
|
|
Comorbidities
Time Frame: At the time of preoperative assesment
|
hipertension, diabetus mellitus, asthma or cardiac disease etc.
|
At the time of preoperative assesment
|
|
surgical technique
Time Frame: At the time of perioperative assesment
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radical or partial nephrectomy and open or laparoscopic nephrectomy
|
At the time of perioperative assesment
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|
surgical duration
Time Frame: The time recorded at the end of the surgery will be reported
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How long does the surgery take in minutes?
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The time recorded at the end of the surgery will be reported
|
|
additional procedures next to the nephrectomy
Time Frame: At the time of perioperative assesment
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lymph node dissection, thrombectomy, adrenalectomy procedures used
|
At the time of perioperative assesment
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|
need for blood transfusion
Time Frame: At the time of perioperative assesment
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How many blood product tranfusions were required?
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At the time of perioperative assesment
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need for intensive care units
Time Frame: At the time of postoperative assesment, the data evaluated at the end of the surgery will be reported
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Whether there is a need for intensive care after surgery
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At the time of postoperative assesment, the data evaluated at the end of the surgery will be reported
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Analgesia technique
Time Frame: At the time of perioperative assesment
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Epidural analgesia or intravenous analgesia was used as analgesic technique
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At the time of perioperative assesment
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Amount of vasopressors used
Time Frame: At the time of perioperative assesment
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Amount of vasopressors used at the perioperative period
|
At the time of perioperative assesment
|
|
Value of postoperative acute pain score on NRS score
Time Frame: 1 hour postoperative period
|
Value of postoperative acute pain score on NRS score(0:no pain, 10:the worst pain imaginable)
|
1 hour postoperative period
|
|
Chronic analgesic use history
Time Frame: 1 year before the operation
|
More than 3 uses per a week
|
1 year before the operation
|
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Clinical conditions that will be reported under the title of central sensitization disorder
Time Frame: At the time of preoperative assesment
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Presence of fibromyalgia, frequent urinary tract infection, bruxism, diagnosed with depression-panic attack, allergic asthma, irritable bowel syndrome and migraines will be recorded.
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At the time of preoperative assesment
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Aylin Nizamoglu, Doctor, Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicine
- Study Chair: Safak E Erbabacan, associate professor, Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicine
- Study Chair: Fatis Altindas, Professor, Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicine
- Principal Investigator: İlayda Bilgili Altuntaş, Physician, Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-83045809-604.01-1084787
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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