Postoperative PainNCT06957158
The Effect of Serum Calcium Levels on Postoperative Pain: A Prospective Observational Study
An observational study of Postoperative Pain, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Peripheral venous blood and Arterial blood
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- Jul 2025to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent elective abdominal surgery under general anesthesia
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
Guangyou Duan, PhD, +86 183 2337 6014, duangy@hospital.cqmu.edu.cn
Guangyou Duan, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- Peripheral venous blood, Arterial blood
- Keywords
- Serum calcium levels, Postoperative pain, Ionized calcium levels
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral venous bloodDiagnostic test
Peripheral venous blood was collected before and after the surgery to measure the total serum calcium levels.
Arterial bloodDiagnostic test
Arterial blood was collected before anesthesia induction and after removal of the artificial airway to measure ionized calcium levels.
What is being measured
The primary outcome is the main question the study is designed to answer.
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）
Measured: From the end of the surgery to 48 hours after surgery
Secondary outcomes (8)
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）
Measured: 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）
Measured: 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）
Measured: 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）
Measured: 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）
Measured: 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）
Measured: 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
Measured: 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
Measured: From the end of the surgery to 24 hours and 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study startJul 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957158
- Sponsor's protocol ID
- Serum calcium levels and pain
- Status last verified
- Apr 2025
- First submitted
- 26 Apr 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data for this study is available from the sponsor on reasonable request through email
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Serum Calcium Levels on Postoperative Pain in Patients Undergoing Abdominal Surgery: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06957158
- Acronym / sponsor ID
- Serum calcium levels and pain
- Conditions
- Postoperative Pain
- Keywords
- Serum calcium levels, Postoperative pain, Ionized calcium levels
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 4 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent elective abdominal surgery under general anesthesia
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral venous bloodPeripheral venous blood was collected before and after the surgery to measure the total serum calcium levels. | Diagnostic test | – |
| Arterial bloodArterial blood was collected before anesthesia induction and after removal of the artificial airway to measure ionized calcium levels. | Diagnostic test | – |
Primary outcome
The incidence of pain NRS score ≥6 within 48 hours after surgery
Time frame: From the end of the surgery to 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）
8 secondary outcomes
The maximum incisional pain score at 0-12h postoperatively
Time frame: From the end of the surgery to 12 hours after surgery
The maximum incisional pain score at 12-24h postoperatively
Time frame: From 12hours to 24 hours after surgery
The maximum incisional pain score at 24-48h postoperatively
Time frame: From 24 hours to 48 hours after surgery
The maximum visceral pain score at 0-12h postoperatively
Time frame: From the end of the surgery to 12 hours after surgery
The maximum visceral pain score at 12-24h postoperatively
Time frame: From 12 hours to 24 hours after surgery
The maximum visceral pain score at 24-48h postoperatively
Time frame: From 24 hours to 48 hours after surgery
Whether additional analgesia was administered within 48 hours after surgery
Time frame: From the end of the surgery to 48 hours after surgery
Patient-controlled intravenous analgesia opioid consumption
Time frame: From the end of the surgery to 24 hours and 48 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Individual participant dataSharing planned: Yes. The individual participant data for this study is available from the sponsor on reasonable request through email
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guangyou Duan, PhD (+86 183 2337 6014, duangy@hospital.cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of pain NRS score ≥6 within 48 hours after surgery (time frame: From the end of the surgery to 48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.