Serum Potassium as a Predictor of Clinical Outcomes in an Older Patient Cohort With Chronic Postsurgical Pain

Serum Potassium as a Predictor of Clinical Outcomes in an Older Patient Cohort With Chronic Postsurgical Pain: Retrospective Analysis of A Multi-Center Prospective Database in China

Perioperative serum potassium in patients over 65 impacts recovery, quality of life and physical functioning. While perioperative serum potassium is an important preoperative risk factor for poor surgical outcomes in older adults, the relationship between perioperative serum potassium and postsurgical pain in this population has not been investigated. The investigators hypothesized that preoperative serum potassium would be associated with greater odds of postsurgical chronic pain.

Study Overview

• Status: Completed
• Conditions: Potassium, Decreased Level; Postsurgical Pain, Chronic
• Intervention / Treatment: Other: NO intervention

Detailed Description

This study is a secondary interim analysis of 'Perioperative Database of Chinese Elderly Patients,' an ongoing prospective observational cohort study that began in 2020 at the muti-center in China with the primary aim of complications in older adults before and after surgery. The investigators described the demographics, comorbidities, and assessment scores as n (percentage) or mean (SD), as appropriate. Unadjusted bivariate analyses included t-test or χ2 test to compare differences between minimal pain and intrusive pain at 3 months after surgery based on demographics, preoperative status, baseline pain status and perioperative serum potassium. The investigators then created a logistic regression model with the outcome of persistent pain at 3 months after surgery and serum potassiumas the main predictor, adjusting for baseline pain, surgery type and surgery part and frailty status based on the hypothesis and association. The investigators also tested for the interaction between baseline pain and serum potassiumas.

• Study Type: Observational
• Enrollment (Actual): 3088

Contacts and Locations

Study Locations

• China
  • Beijing, Beijing, China
    • Beijing, Beijing, Beijing, China, China, 100853
      • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

hospital based group

Description

Inclusion Criteria:

• Geriatric surgical patients ≥65 years old
• Diagnosis of Chronic postsurgical pain (CPSP) CPSP was made based on the guidelines of the International Society for Pain (CPSP: ICD-11) as follows: Chronic postsurgical pain is chronic pain developing or increasing in intensity after a surgical procedure and persisting beyond the healing process, i.e. at least 3 months after surgery. The pain is either localised to the surgical field, projected to the innervation territory of a nerve situated in this area, or referred to a dermatome (after surgery/injury to deep somatic or visceral tissues). Other causes of pain including infection, malignancy etc. need to be excluded as well as pain continuing from a pre-existing pain problem. Dependent on type of surgery, chronic postsurgical pain often may be neuropathic pain.

Exclusion Criteria:

• Patients in the central nervous system group were excluded from cardiac and neurosurgery, patients in the heart injury group were excluded from cardiac surgery.
• patients who did not agree to participate in the study were excluded in all groups.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CPSP group; Patients who developed chronic pain 3 months after surgery	Other: NO intervention; NO intervention
UN-CPSP group; Patients who did not develop chronic pain 3 months after surgery	Other: NO intervention; NO intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain trajectories after surgery (Numerical Rating Scale)	Pain intensity was assessed using a numerical rating scale (NRS) from 0 to 10, with zero representing no pain and 10 representing worst imaginable pain. The worst pain intensity was then categorized into two groups: no or mild pain (NRS from 0 to 3) and moderate to severe pain (NRS from 4 to 10).	Up to 3 months postoperation
The Brief Pain Inventory-short form	It measured pain location in the body; pain intensity on an 11-point numerical rating scale (NRS; 0 represents "no pain" and 10 the "worst pain imaginable"); analgesic intake; perception of analgesic relief; and pain interference with daily life on an 11-point NRS (0 "does not interfere and 10"completely interferes") indistinct dimensions (general activity, mood, walking, work, relations with others, sleep, and enjoyment of life). Higher scores represent higher levels of pain interference.	Up to 3 months postoperation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The trajectories of health related quality of life(HRQoL)	The trajectory of HRQoL is the vector of Utility values measured with EuroQol five-dimensional questionnaire(EQ-5D-5L)taken over 3 months(days 1, 3, 7, 30, 90；Day 0 is the day of surgery). The EQ-5D-5L measures health on five domains (mobility, self-care, usual activities, pain discomfort, and anxiety-depression), and the scores will be combined using Chinese general population weights to generate a single utility or index score. Utility values for the EQ-5D range from 1.00 to -0.391, where a score of 0 and 1 are regarded as equivalent to death and 'perfect health', respectively, and a score < 0 is considered as health state that is 'worse than death'.	within 30 days prior to surgery , 1, 3, 7, 30, 90 days postoperation
Pain Catastrophizing Scale (PCS)	The PCS consists of 13 items, and each item is answered with a numeric value between 0 and 4; 0 corresponding to "not at all", and four corresponded to "all the time". Higher scores indicate a higher level of pain catastrophizing, the Chinese version of the PCS has demonstrated a good reliability and validity (Cronbach's alpha was 0.87 and the ICC was 0.97)	within 30 days prior to surgery ,Up to 3 months postoperation
The Frail Scale	Frailty was assessed prior to surgery using the Frail Scale assessment. The Frail Scale assessment is a validated 5-item scale comprising components from the Cardiovascular Health Frailty Index and Rockwood Scale. The five components measured include fatigue, resistance, ambulation, illness and loss of weight. For each item, choose "yes" and "no", "No" is assigned 0 points, "yes" is assigned 1 point.The total score of the five items is 0-5. (zero representing no frilty and 5 representing worst imaginable frilty.) Patients were classified as frail if they scored 3 or more on the 5-point scale and not frail if they scored below 3.	within 30 days prior to surgery ,Up to 3 months postoperation

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Collaborators: Peking University People's Hospital; Sun Yat-sen University; Fudan University; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; China-Japan Friendship Hospital; The Affiliated Hospital Of Guizhou Medical University; First Affiliated Hospital of Guangxi Medical University
• Investigators: Study Chair: Mi Weidong, PhD, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: May 15, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 23, 2022

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 22, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: elderly; risk factors; serum potassium; Chronic Postsurgical Pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Chronic Pain
• Other Study ID Numbers: PLAGH-CPSP-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No