Risk Factors for Chronic Postoperative Pain After Elective Nephrectomy

NCT ID: NCT06673979

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 220 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2025-09-30

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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".

Numeric Rating Scale

Intervention Type: 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

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".

Numeric Rating Scale

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Numeric Rating Scale

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

İlayda Bilgili Altuntaş

Principal investigator, Anesthesiology and Reanimation, Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aylin Nizamoglu, Doctor

Role: STUDY_DIRECTOR

Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicine

Safak E Erbabacan, associate professor

Role: STUDY_CHAIR

Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicine

Fatis Altindas, Professor

Role: STUDY_CHAIR

Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicine

Ilayda Bilgili Altuntas, Physician

Role: PRINCIPAL_INVESTIGATOR

Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicine

Locations

Istanbul University-Cerrahpasa

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Ilayda Bilgili Altuntas, Physician

Role: CONTACT

bilgiliilayda@gmail.com

+905453771001

Facility Contacts

Ilayda Bilgili Altuntas

Role: primary

bilgiliilayda@gmail.com

00905453771001

References

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.

Reference Type: BACKGROUND

PMID: 34121077 (View on PubMed)

Related Links

https://profiles.wustl.edu/en/publications/perioperative-factors-associated-with-persistent-postsurgical-pai

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

Other Identifiers

E-83045809-604.01-1084787

Identifier Type: -

Identifier Source: org_study_id