Risk Factors for Chronic Postoperative Pain After Elective Nephrectomy

NCT06673979 | Completed DMC

• 1 other identifier: E-83045809-604.01-1084787
• Study Type: observational
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

General Anesthesia; Chronic Pain, Postoperative; Acute Pain, Postoperative; Surgery; Anesthesia; Chronic Pain; Analgesic Drugs; Epidural Analgesia; Nephrectomy

Keywords

chronic pain; nephrectomy; surgery; pain risk factors; acute pain; postoperative pain

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  1 year after the surgery

Secondary Outcomes (17)

• 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

Study Arms (2)

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".

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".

Diagnostic Test: Numeric Rating Scale

Interventions

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).

Pain-free: patients with Numeric Rating Score lower than 4; Painfull: patients with Numeric Rating Score equal or higher than 4

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged 18-90 years, ASA I-IV, undergoing elective nephrectomy under general anesthesia will be included in the study.

You may qualify if:

• ASA I-IV,
• undergoing elective nephrectomy under general anesthesia will be included in the study.

You may not qualify if:

• Patients who cannot be reached by phone and hose who die within the 1-year postoperative period will be excluded from the study.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 34121077 BACKGROUND

Related Links

• Perioperative factors associated with persistent postsurgical pain after hysterectomy, cesarean section, prostatectomy, and donor nephrectomy: A systematic review and meta-analysis

MeSH Terms

Conditions

Pain, Postoperative; Chronic Pain; Acute Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Aylin Nizamoglu, Doctor

  Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicine

  STUDY DIRECTOR

• Safak E Erbabacan, associate professor

  Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicine

  STUDY CHAIR

• Fatis Altindas, Professor

  Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicine

  STUDY CHAIR

• Ilayda Bilgili Altuntas, Physician

  Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Anesthesiology and Reanimation, Physician

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: November 5, 2024
• Study Start: August 1, 2025
• Primary Completion: March 24, 2026
• Study Completion: March 24, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)