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Clinical Trials/NCT06673979
NCT06673979
Recruiting
Not Applicable

Risk Factors Affecting Chronic Postoperative Pain After Elective Nephrectomy

Istanbul University - Cerrahpasa1 site in 1 country220 target enrollmentAugust 1, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
General Anesthesia
Sponsor
Istanbul University - Cerrahpasa
Enrollment
220
Locations
1
Primary Endpoint
NRS 1 hour
Status
Recruiting
Last Updated
9 months ago

Overview

Brief 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]. 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.

Registry
clinicaltrials.gov
Start Date
August 1, 2025
End Date
September 30, 2025
Last Updated
9 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Istanbul University - Cerrahpasa
Responsible Party
Principal Investigator
Principal Investigator

İlayda Bilgili Altuntaş

Principal investigator, Anesthesiology and Reanimation, Physician

Istanbul University - Cerrahpasa

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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 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

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

Secondary Outcomes

  • age(At the time of preoperative assesment)
  • height(At the time of preoperative assesment)
  • BMI(At the time of preoperative assesment)
  • smoking(At the time of preoperative assesment)
  • Amount of opioid and non-opioid analgesics used perioperatively(At the time of perioperative assesment)
  • Gender(At the time of preoperative assesment)
  • surgical technique(At the time of perioperative assesment)
  • surgical duration(The time recorded at the end of the surgery will be reported)
  • Value of postoperative acute pain score on NRS score(1 hour postoperative period)
  • Comorbidities(At the time of preoperative assesment)
  • additional procedures next to the nephrectomy(At the time of perioperative assesment)
  • need for blood transfusion(At the time of perioperative assesment)
  • need for intensive care units(At the time of postoperative assesment, the data evaluated at the end of the surgery will be reported)
  • Analgesia technique(At the time of perioperative assesment)
  • Amount of vasopressors used(At the time of perioperative assesment)
  • Chronic analgesic use history(1 year before the operation)
  • Clinical conditions that will be reported under the title of central sensitization disorder(At the time of preoperative assesment)

Study Sites (1)

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