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Completed

NCT Number: NCT06673979

Risk Factors for 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.

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Key information

Conditions

General Anesthesia Acute Pain Acute Pain, Postoperative Analgesic Drugs Anesthesia Chronic Pain Chronic Pain, Postoperative Epidural Analgesia Nephrectomy Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Surgery

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Numeric Rating Scale

Diagnostic Test

The patients are asked to rate their pain according to the Numeric Rating Scale (0=no pain; 10=worse possible pain).

Primary outcomes

  1. 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

  2. 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. 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

Secondary outcomes

  1. age

    Time frame: At the time of preoperative assesment

    Age of the patiens as years

  2. height

    Time frame: At the time of preoperative assesment

    Height of the patiens as meter

  3. BMI

    Time frame: At the time of preoperative assesment

    body mass index of the patiens as kg/m2

  4. smoking

    Time frame: At the time of preoperative assesment

    Data of the patient if they are smoking or not

  5. Amount of opioid and non-opioid analgesics used perioperatively

    Time frame: At the time of perioperative assesment

    Amount of opioid and non-opioid analgesics used perioperatively

  6. Gender

    Time frame: At the time of preoperative assesment

    Woman or man

  7. Comorbidities

    Time frame: At the time of preoperative assesment

    hipertension, diabetus mellitus, asthma or cardiac disease etc.

  8. surgical technique

    Time frame: At the time of perioperative assesment

    radical or partial nephrectomy and open or laparoscopic nephrectomy

  9. surgical duration

    Time frame: The time recorded at the end of the surgery will be reported

    How long does the surgery take in minutes?

  10. additional procedures next to the nephrectomy

    Time frame: At the time of perioperative assesment

    lymph node dissection, thrombectomy, adrenalectomy procedures used

  11. need for blood transfusion

    Time frame: At the time of perioperative assesment

    How many blood product tranfusions were required?

  12. 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

    Whether there is a need for intensive care after surgery

  13. Analgesia technique

    Time frame: At the time of perioperative assesment

    Epidural analgesia or intravenous analgesia was used as analgesic technique

  14. Amount of vasopressors used

    Time frame: At the time of perioperative assesment

    Amount of vasopressors used at the perioperative period

  15. 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)

  16. Chronic analgesic use history

    Time frame: 1 year before the operation

    More than 3 uses per a week

  17. Clinical conditions that will be reported under the title of central sensitization disorder

    Time frame: At the time of preoperative assesment

    Presence of fibromyalgia, frequent urinary tract infection, bruxism, diagnosed with depression-panic attack, allergic asthma, irritable bowel syndrome and migraines will be recorded.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

Risk Factors Affecting Chronic Postoperative Pain After Elective Nephrectomy

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 5, 2024
Registry last updated
Mar 25, 2026

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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