Pain Trajectories and Predictors After Noncardiac Surgery in Elderly Patients

Acute Postoperative Pain Clinical Trial

Official title:

Pain Trajectories and Predictors After Noncardiac Surgery in Elderly Patients: a Prospective and Observational Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05865366
• Other study ID #: TJ-IRB202303136
• Status: Not yet recruiting
• Start date: June 1, 2023
• Est. completion date: June 25, 2024

Study information

• Verified date: May 2023
• Source: Tongji Hospital
• Contact: Gao Feng, Doctor
• Phone: 13971587381
• Email: fgao[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: June 25, 2024
• Est. primary completion date: June 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Postoperative Pain
• Pain, Postoperative

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Feng Gao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute pain trajectories after surgery	The acute pain trajectories are vectors of 7 numerical pain scores (ranging from 0 ,which indicates "no pain," to 10 , which indicates "pain as bad as you can imagine") taken over 7 days (days 1, 2, 3, 4, 5, 6, 7).	Seven days after surgery.
Primary	Presence of pain 3 months after surgery assessed using the Brief Pain Inventory.	Yes/No	3 months after surgery
Primary	Presence of pain 6 months after surgery assessed using the Brief Pain Inventory.	Yes/No	6 months after surgery
Secondary	consumption of analgesic drugs	the amount of analgesic drugs will be recorded	Seven days after surgery
Secondary	cumulative illness rating scale for geriatrics,CIR S-G	The Cumulative Illness Rating Scale (CIRS) is utilized to assess comorbidities and comprises of 14 components, each with a severity score ranging from 0 to 4. A score of 0 indicates no damage, while a score of 1 denotes minor damage that does not impede normal activity and has a positive prognosis without treatment. A score of 2 indicates moderate damage, while a score of 3 denotes severe damage that may result in disability and necessitates immediate treatment with a poor prognosis. A score of 4 indicates fatal damage that requires urgent treatment and has a severe prognosis.	day1 before surgery
Secondary	The FRAIL Scale(Fatigue, Resistance, Ambulation, Illness and Loss of Weight Index,FRAIL)	The scale includes fatigue, resistance, ability to walk a block, concomitant illness, and weight loss. Frailty is defined by the presence of three or more of the criteria.	day1 before surgery
Secondary	The douleur neuropathique 4 questionnaire(DN4)	This questionnaire serves as a diagnostic tool for identifying neuropathic pain. It comprises 10 options, consisting of 7 self-assessment items that evaluate symptoms. The total score is 10 points, and a score of = 4 indicates the possibility of neuropathic pain, while a score < 4 rules out neuropathic pain.	day1 before surgery
Secondary	Mini-cog	The Mini-Cog uses recall and clock-drawing tests to determine whether patients have cognitive impairments. A score of 0-2 indicates a positive dementia screening, while a score of 3-5 implies a negative screening, necessitating further evaluation.	day1 before surgery
Secondary	The anxiety score assessed using Amsterdam preoperative anxiety and information scale	The Amsterdam preoperative anxiety and information scale is a tool utilized to assess the level of anxiety and the amount of information patients possess before undergoing surgery.The items can be categorized into three groups - anesthesia-related anxiety score (item 1+item 2), surgery-related anxiety score (item 3+item 4), and information needs score (item 5+item 6).; The total anxiety score is the sum of the scores for anesthesia-related anxiety and surgery-related anxiety, with higher scores indicating greater levels of anxiety.	day1 before surgery
Secondary	Geriatrie depression scale,GDS-15	This scale serves as a diagnostic tool to screen for depression in the elderly population. A rating of 0 to 5 is within the normal range, while a score of 5 or above is indicative of a possible depression. If the total score exceeds 10, it may be appropriate to refer the individual to a psychiatric specialist for further assessment and diagnosis.	day1 before surgery
Secondary	Complications within 7 days after surgery	Complications will be recorded.	Seven days after surgery
Secondary	Presence of pain before surgery assessed using the Brief Pain Inventory.	Yes/No	day1 before surgery