Clinical trial NCT06673979: Risk Factors for Chronic Postoperative Pain After Elective Nephrectomy
Official title: Risk Factors Affecting Chronic Postoperative Pain After Elective Nephrectomy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: NRS 1 hour
timeFrame: 1 hour after the end of the surgery
measure: NRS 3 months
timeFrame: 3 months after the surgery
measure: NRS 1 year
timeFrame: 1 year after the surgery
Secondary outcomes:
measure: age
timeFrame: At the time of preoperative assesment
measure: height
timeFrame: At the time of preoperative assesment
measure: BMI
timeFrame: At the time of preoperative assesment
measure: smoking
timeFrame: At the time of preoperative assesment
measure: Amount of opioid and non-opioid analgesics used perioperatively
timeFrame: At the time of perioperative assesment
measure: Gender
timeFrame: At the time of preoperative assesment
measure: Comorbidities
timeFrame: At the time of preoperative assesment
measure: surgical technique
timeFrame: At the time of perioperative assesment
measure: surgical duration
timeFrame: The time recorded at the end of the surgery will be reported
measure: additional procedures next to the nephrectomy
timeFrame: At the time of perioperative assesment
measure: need for blood transfusion
timeFrame: At the time of perioperative assesment
measure: need for intensive care units
timeFrame: At the time of postoperative assesment, the data evaluated at the end of the surgery will be reported
measure: Analgesia technique
timeFrame: At the time of perioperative assesment
measure: Amount of vasopressors used
timeFrame: At the time of perioperative assesment
measure: Value of postoperative acute pain score on NRS score
timeFrame: 1 hour postoperative period
measure: Chronic analgesic use history
timeFrame: 1 year before the operation
measure: Clinical conditions that will be reported under the title of central sensitization disorder
timeFrame: At the time of preoperative assesment
Other outcomes:
Locations:
Study officials:
affiliation: Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicine
name: Aylin Nizamoglu, Doctor
role: STUDY_DIRECTOR
affiliation: Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicine
name: Safak E Erbabacan, associate professor
role: STUDY_CHAIR
affiliation: Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicine
name: Fatis Altindas, Professor
role: STUDY_CHAIR
affiliation: Istanbul Univerisity-Cerrahpasa Cerrahpasa Faculty of Medicine
name: Ilayda Bilgili Altuntas, Physician
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.