Clinical trial NCT05865366: Pain Trajectories and Predictors After Noncardiac Surgery in Elderly Patients
Official title: Pain Trajectories and Predictors After Noncardiac Surgery in Elderly Patients: a Prospective and Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Postoperative Pain
Trajectory
Keywords: acute postoperative pain, pain trajectory, chronic pain, elderly patient
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: elderly patients scheduled for thoracic, urologic, gastrointestinal, gynecological, liver, biliary/pancreatic, and major orthopedic surgeries under general anesthesia

Brief summary: This study will use group-based trajectory modeling to identify the different postoperative pain trajectory groups that exist in a mixed surgical population (non-cardiac surgery) of elderly patients during the first seven days after surgery. The aim of this study is to explore the diversity in the development of postoperative pain among elderly patients and to identify the risk factors for acute pain trajectory after surgery by investigating demographic, psychological, and clinical variables. The predictive effect of different trajectories of early postoperative acute pain on postoperative chronic pain will also be explored.


Eligibility criteria: Inclusion Criteria:

1. Scheduled for thoracic, urologic, gastrointestinal, gynecological, liver, biliary/pancreatic, or major orthopedic surgery under general anesthesia
2. Age ≥ 65 years
3. The American Society of Anaesthesiologists(ASA) I to III
4. Duration of hospitalization ≥ 72 hours

Exclusion Criteria:

1. Language disorder;
2. Hearing impairment;
3. Visual impairment;
4. The expected postoperative intubation time is more than 24 hours;
5. Critical events occurred during the perioperative period.

Primary outcomes:
measure: Acute pain trajectories after surgery
timeFrame: Seven days after surgery.
measure: Presence of pain 3 months after surgery assessed using the Brief Pain Inventory.
timeFrame: 3 months after surgery
measure: Presence of pain 6 months after surgery assessed using the Brief Pain Inventory.
timeFrame: 6 months after surgery
Secondary outcomes:
measure: consumption of analgesic drugs
timeFrame: Seven days after surgery
measure: cumulative illness rating scale for geriatrics，CIR S-G
timeFrame: day1 before surgery
measure: The FRAIL Scale(Fatigue, Resistance, Ambulation, Illness and Loss of Weight Index，FRAIL)
timeFrame: day1 before surgery
measure: The douleur neuropathique 4 questionnaire(DN4)
timeFrame: day1 before surgery
measure: Mini-cog
timeFrame: day1 before surgery
measure: The anxiety score assessed using Amsterdam preoperative anxiety and information scale
timeFrame: day1 before surgery
measure: Geriatrie depression scale，GDS-15
timeFrame: day1 before surgery
measure: Complications within 7 days after surgery
timeFrame: Seven days after surgery
measure: Presence of pain before surgery assessed using the Brief Pain Inventory.
timeFrame: day1 before surgery
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
References: