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

NCT06957158 | Recruiting DMC

• 1 other identifier: Serum calcium levels and pain
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain

Keywords

Serum calcium levels; Postoperative pain; Ionized calcium levels

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• The maximum incisional pain score at 0-12h postoperatively

  From the end of the surgery to 12 hours after surgery

• The maximum incisional pain score at 12-24h postoperatively

  From 12hours to 24 hours after surgery

• The maximum incisional pain score at 24-48h postoperatively

  From 24 hours to 48 hours after surgery

• The maximum visceral pain score at 0-12h postoperatively

  From the end of the surgery to 12 hours after surgery

• The maximum visceral pain score at 12-24h postoperatively

  From 12 hours to 24 hours after surgery

Interventions

Peripheral venous blood DIAGNOSTIC_TEST

Peripheral venous blood was collected before and after the surgery to measure the total serum calcium levels.

Arterial blood DIAGNOSTIC_TEST

Arterial blood was collected before anesthesia induction and after removal of the artificial airway to measure ionized calcium levels.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent elective abdominal surgery under general anesthesia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood and arterial blood were collected

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Arterial Pressure

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Pressure; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Guangyou Duan, PhD

CONTACT

+86 183 2337 6014; duangy@hospital.cqmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2025
• First Posted: May 4, 2025
• Study Start: July 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Five years after the study

Locations

CN (1)