The Effect of Serum Calcium Levels on Postoperative Pain: A Prospective Observational Study

The Effect of Serum Calcium Levels on Postoperative Pain in Patients Undergoing Abdominal Surgery: A Prospective Observational Study

This is a prospective observational study. To investigate the effect of serum calcium levels on postoperative pain in patients undergoing abdominal surgery, and to determine whether changes in serum calcium levels are a risk factor for postoperative pain.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Diagnostic test: Peripheral venous blood; Diagnostic test: Arterial blood

Detailed Description

This study aimed to measure the total serum calcium and ionized calcium levels both before and after surgery. Additionally, NRS scores were recorded at different time points.

• Study Type: Observational
• Enrollment (Estimated): 350

Contacts and Locations

• Study Contact: Name: Guangyou Duan, PhD; Phone Number: +86 183 2337 6014; Email: duangy@hospital.cqmu.edu.cn

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400010
      • Recruiting
      • The Second Affiliated Hospital of Chongqing Medical University
      • Contact: Guangyou Duan, PhD; Phone Number: +86 183 2337 6014; Email: duangy@hospital.cqmu.edu.cn
      • Principal Investigator: Guangyou Duan, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent elective abdominal surgery under general anesthesia

Description

Inclusion Criteria:

• Aged 18-70 years old
• American Society of Anesthesiologists Classification I-III
• Patients undergoing elective abdominal surgery under general anesthesia
• Patients participate voluntarily and sign an informed consent form

Exclusion Criteria:

• Patients with a history of severe disease
• Patients with chronic preoperative pain and/or long-term analgesic use
• Patients with hearing disorders or verbal communication difficulties
• Patients with psychiatric disorders or cognitive dysfunction
• Patients requiring mechanical ventilation or ICU admission after surgery
• Patients with a history of substance or alcohol abuse Patients who could not cooperate with the study for any reason

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of pain NRS score ≥6 within 48 hours after surgery	NRS score: pain was assessed using a 10-point NRS (range: 0-10, 0 and 10 indicate no pain and the most extreme pain imaginable, respectively）	From the end of the surgery to 48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The maximum incisional pain score at 0-12h postoperatively	NRS score: pain was assessed using a 10-point NRS (range: 0-10, 0 and 10 indicate no pain and the most extreme pain imaginable, respectively）	From the end of the surgery to 12 hours after surgery
The maximum incisional pain score at 12-24h postoperatively	NRS score: pain was assessed using a 10-point NRS (range: 0-10, 0 and 10 indicate no pain and the most extreme pain imaginable, respectively）	From 12hours to 24 hours after surgery
The maximum incisional pain score at 24-48h postoperatively	NRS score: pain was assessed using a 10-point NRS (range: 0-10, 0 and 10 indicate no pain and the most extreme pain imaginable, respectively）	From 24 hours to 48 hours after surgery
The maximum visceral pain score at 0-12h postoperatively	NRS score: pain was assessed using a 10-point NRS (range: 0-10, 0 and 10 indicate no pain and the most extreme pain imaginable, respectively）	From the end of the surgery to 12 hours after surgery
The maximum visceral pain score at 12-24h postoperatively	NRS score: pain was assessed using a 10-point NRS (range: 0-10, 0 and 10 indicate no pain and the most extreme pain imaginable, respectively）	From 12 hours to 24 hours after surgery
The maximum visceral pain score at 24-48h postoperatively	NRS score: pain was assessed using a 10-point NRS (range: 0-10, 0 and 10 indicate no pain and the most extreme pain imaginable, respectively）	From 24 hours to 48 hours after surgery
Whether additional analgesia was administered within 48 hours after surgery	The proportion of patients who received additional analgesia out of the total patient group	From the end of the surgery to 48 hours after surgery
Patient-controlled intravenous analgesia opioid consumption	PCIA opioid consumption was assessed by checking the PCIA electronic system	From the end of the surgery to 24 hours and 48 hours after surgery

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: April 26, 2025
• First Submitted That Met QC Criteria: April 26, 2025
• First Posted (Actual): May 4, 2025

Study Record Updates

• Last Update Posted (Actual): June 27, 2025
• Last Update Submitted That Met QC Criteria: June 24, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Postoperative pain; Serum calcium levels; Ionized calcium levels
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative
• Other Study ID Numbers: Serum calcium levels and pain

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The individual participant data for this study is available from the sponsor on reasonable request through email
• IPD Sharing Time Frame: Five years after the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

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