General AnesthesiaNCT06673979
Risk Factors for Chronic Postoperative Pain After Elective Nephrectomy
An observational study of General Anesthesia and Chronic Pain, Postoperative, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
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]. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- General Anesthesia, Chronic Pain, Postoperative, Acute Pain, Postoperative
- What is being tested?
- Numeric Rating Scale
- How many people
- 204 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 24 Mar 2026
- How long will I take part?
- 1 Year
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18-90 years, ASA I-IV, undergoing elective nephrectomy under general anesthesia will be included in the study.
Who may be able to join
- ASA I-IV,
- undergoing elective nephrectomy under general anesthesia will be included in the study.
Who cannot join
- Patients who cannot be reached by phone and hose who die within the 1-year postoperative period will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
Patients gender, age, height(m), weight(kg), body mass index(kg/m2), diagnosis, smoking and alcohol history, comorbidities, surgical technique and duration, complications, lymph node dissection, thrombectomy, adrenalectomy, amount of bleeding(cc), need for blood transfusion, need for intensive care, analgesia technique used, amount of opioids and non-opioid analgesics used perioperatively, amount of vasopressors used, heart rate(bpm) and mean arterial pressure(mmHg) at induction, post-intubation, post-extubation, and 1 hour postoperatively, presence of postoperative pain, chronic analgesic use history(more than 3 uses per week), presence of fibromyalgia, frequent urinary tract infections, diagnosed with central sensitization disorders, bruxism, depression-panic attacks, allergic asthma, irritable bowel syndrome, and migraines will be recorded. The effects of these factors on NRS scores at 1 hour, 3 months, and 1 year postoperatively will be examined.
- Conditions
- General Anesthesia, Chronic Pain, Postoperative, Acute Pain, Postoperative, Surgery, Anesthesia, Chronic Pain
- Being tested
- Numeric Rating Scale
- Keywords
- chronic pain, nephrectomy, surgery, pain risk factors, acute pain, postoperative pain
- Medical subject headings
- Pain, Postoperative, Chronic Pain, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Numeric Rating ScaleDiagnostic test
The patients are asked to rate their pain according to the Numeric Rating Scale (0=no pain; 10=worse possible pain).
| Study group | Role | What they receive |
|---|---|---|
| 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". Receives: Diagnostic Test: Numeric Rating Scale | |
| 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". Receives: Diagnostic Test: Numeric Rating Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS 1 hour
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
Measured: 1 hour after the end of the surgery
NRS 3 months
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
Measured: 3 months after the surgery
NRS 1 year
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
Measured: 1 year after the surgery
Secondary outcomes (17)
age
Age of the patiens as years
Measured: At the time of preoperative assesment
height
Height of the patiens as meter
Measured: At the time of preoperative assesment
BMI
body mass index of the patiens as kg/m2
Measured: At the time of preoperative assesment
smoking
Data of the patient if they are smoking or not
Measured: At the time of preoperative assesment
Amount of opioid and non-opioid analgesics used perioperatively
Amount of opioid and non-opioid analgesics used perioperatively
Measured: At the time of perioperative assesment
Gender
Woman or man
Measured: At the time of preoperative assesment
Comorbidities
hipertension, diabetus mellitus, asthma or cardiac disease etc.
Measured: At the time of preoperative assesment
surgical technique
radical or partial nephrectomy and open or laparoscopic nephrectomy
Measured: At the time of perioperative assesment
surgical duration
How long does the surgery take in minutes?
Measured: The time recorded at the end of the surgery will be reported
additional procedures next to the nephrectomy
lymph node dissection, thrombectomy, adrenalectomy procedures used
Measured: At the time of perioperative assesment
need for blood transfusion
How many blood product tranfusions were required?
Measured: At the time of perioperative assesment
need for intensive care units
Whether there is a need for intensive care after surgery
Measured: At the time of postoperative assesment, the data evaluated at the end of the surgery will be reported
Analgesia technique
Epidural analgesia or intravenous analgesia was used as analgesic technique
Measured: At the time of perioperative assesment
Amount of vasopressors used
Amount of vasopressors used at the perioperative period
Measured: At the time of perioperative assesment
Value of postoperative acute pain score on NRS score
Value of postoperative acute pain score on NRS score(0:no pain, 10:the worst pain imaginable)
Measured: 1 hour postoperative period
Chronic analgesic use history
More than 3 uses per a week
Measured: 1 year before the operation
Clinical conditions that will be reported under the title of central sensitization disorder
Presence of fibromyalgia, frequent urinary tract infection, bruxism, diagnosed with depression-panic attack, allergic asthma, irritable bowel syndrome and migraines will be recorded.
Measured: At the time of preoperative assesment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start1 Aug 2025
- Primary completion24 Mar 2026
- Study completion24 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 204 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlayda Bilgili Altuntaş, Istanbul University - Cerrahpasa
- Investigators
- Aylin Nizamoglu, Doctor, Study director, Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of MedicineSafak E Erbabacan, associate professor, Study chair, Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of MedicineFatis Altindas, Professor, Study chair, Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of MedicineIlayda Bilgili Altuntas, Physician, Principal investigator, Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673979
- Sponsor's protocol ID
- E-83045809-604.01-1084787
- Status last verified
- Mar 2026
- First submitted
- 25 Sep 2024
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sharma LR, Schaldemose EL, Alaverdyan H, Nikolajsen L, Chen D, Bhanvadia S, Komen H, Yaeger L, Haroutounian S. Perioperative factors associated with persistent postsurgical pain after hysterectomy, cesarean section, prostatectomy, and donor nephrectomy: a systematic review and meta-analysis. Pain. 2022 Mar 1;163(3):425-435. doi: 10.1097/j.pain.0000000000002361.
PubMed 34121077
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors Affecting Chronic Postoperative Pain After Elective Nephrectomy
- ClinicalTrials.gov ID
- NCT06673979
- Acronym / sponsor ID
- E-83045809-604.01-1084787
- Conditions
- General Anesthesia, Chronic Pain, Postoperative, Acute Pain, Postoperative, Surgery, Anesthesia, Chronic Pain
- Keywords
- chronic pain, nephrectomy, surgery, pain risk factors, acute pain, postoperative pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 24 Mar 2026 (actual)
- Study completion
- 24 Mar 2026 (actual)
- First posted
- 5 Nov 2024 (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.
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.
Detailed description
Patients gender, age, height(m), weight(kg), body mass index(kg/m2), diagnosis, smoking and alcohol history, comorbidities, surgical technique and duration, complications, lymph node dissection, thrombectomy, adrenalectomy, amount of bleeding(cc), need for blood transfusion, need for intensive care, analgesia technique used, amount of opioids and non-opioid analgesics used perioperatively, amount of vasopressors used, heart rate(bpm) and mean arterial pressure(mmHg) at induction, post-intubation, post-extubation, and 1 hour postoperatively, presence of postoperative pain, chronic analgesic use history(more than 3 uses per week), presence of fibromyalgia, frequent urinary tract infections, diagnosed with central sensitization disorders, bruxism, depression-panic attacks, allergic asthma, irritable bowel syndrome, and migraines will be recorded. The effects of these factors on NRS scores at 1 hour, 3 months, and 1 year postoperatively will be examined.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Painfull: patients with Numeric Rating Score equal or higher than 4 | – | Diagnostic Test: Numeric Rating ScaleThe 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". |
| Pain-free: patients with Numeric Rating Score lower than 4 | – | Diagnostic Test: Numeric Rating ScaleThe 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". |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-90 years, ASA I-IV, undergoing elective nephrectomy under general anesthesia will be included in the study.
Key inclusion criteria (2 listed)
- ASA I-IV,
- undergoing elective nephrectomy under general anesthesia will be included in the study.
Key exclusion criteria (1 listed)
- Patients who cannot be reached by phone and hose who die within the 1-year postoperative period will be excluded from the study.
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 |
|---|---|---|
| Numeric Rating ScaleThe patients are asked to rate their pain according to the Numeric Rating Scale (0=no pain; 10=worse possible pain). | Diagnostic test | Pain-free: patients with Numeric Rating Score lower than 4, Painfull: patients with Numeric Rating Score equal or higher than 4 |
Primary outcome
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
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
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
17 secondary outcomes
age
Time frame: At the time of preoperative assesment
height
Time frame: At the time of preoperative assesment
BMI
Time frame: At the time of preoperative assesment
smoking
Time frame: At the time of preoperative assesment
Amount of opioid and non-opioid analgesics used perioperatively
Time frame: At the time of perioperative assesment
Gender
Time frame: At the time of preoperative assesment
Comorbidities
Time frame: At the time of preoperative assesment
surgical technique
Time frame: At the time of perioperative assesment
surgical duration
Time frame: 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
need for blood transfusion
Time frame: At the time of perioperative assesment
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
Analgesia technique
Time frame: At the time of perioperative assesment
Amount of vasopressors used
Time frame: At the time of perioperative assesment
Value of postoperative acute pain score on NRS score
Time frame: 1 hour postoperative period
Chronic analgesic use history
Time frame: 1 year before the operation
Clinical conditions that will be reported under the title of central sensitization disorder
Time frame: At the time of preoperative assesment
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 25 Mar 2026.
- Background: PubMed 34121077Sharma LR, Schaldemose EL, Alaverdyan H, Nikolajsen L, Chen D, Bhanvadia S, Komen H, Yaeger L, Haroutounian S. Perioperative factors associated with persistent postsurgical pain after hysterectomy, cesarean section, prostatectomy, and donor nephrectomy: a systematic review and meta-analysis. Pain. 2022 Mar 1;163(3):425-435. doi: 10.1097/j.pain.0000000000002361.
- Perioperative factors associated with persistent postsurgical pain after hysterectomy, cesarean section, prostatectomy, and donor nephrectomy: A systematic review and meta-analysisLink provided by the sponsor.
- 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.
Aylin Nizamoglu, Doctor study director
Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicine
Safak E Erbabacan, associate professor study chair
Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicine
Fatis Altindas, Professor study chair
Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Anesthesia and Chronic Pain, Postoperative, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 2 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 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
NRS 1 hour (time frame: 1 hour after the end of the surgery). The study lists 3 primary outcomes in all. 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 NCT06673979, which also lists 1 linked publication.
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 25 Mar 2026.