Postoperative Visceral PainNCT07048782
Development and Validation of a Risk Prediction Model for Postoperative Visceral Pain in Abdominal Surgery Patients
An observational study of Postoperative Visceral Pain, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
This study aims to investigate the factors influencing the risk of postoperative visceral pain in patients undergoing abdominal surgery. The goal is to develop and validate a predictive model for assessing the risk of postoperative visceral pain, in order to guide individualized preoperative interventions and pain… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Visceral Pain
- What is being tested?
- Observational assessment of clinical outcomes
- How many people
- 1,135 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 30 Jan 2026
- How long will I take part?
- 2 Days
- 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
- Adult, Older adult
Study population: Patients aged 18 to 70 years who are scheduled to undergo elective abdominal surgery under general anesthesia (including gynecological and general surgeries such as gastrointestinal and hepatobiliary procedures), with an ASA physical status of II to III, and an expected surgery duration of 2 hours or more.
Who may be able to join
- Patients undergoing elective abdominal surgery under general anesthesia (including gynecological procedures and general surgery such as gastrointestinal, hepatobiliary, etc.);
- Aged between 18 and 70 years;
- Classified as American Society of Anesthesiologists (ASA) physical status II-III;
- Expected surgery duration ≥ 2 hours.
Who cannot join
- History of previous abdominal surgery;
- Diagnosed with chronic pain;
- Long-term use of analgesics or other psychotropic medications;
- Preoperative emergency condition;
- Presence of severe comorbidities involving major organ systems;
- Failure to complete postoperative pain follow-up.
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
Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
Guangyou Duan, PhD, (+86)18323376014, duangy@hospital.cqmu.edu.cn
About this study
This study aims to investigate the factors influencing the risk of postoperative visceral pain in patients undergoing abdominal surgery. The goal is to develop and validate a predictive model for assessing the risk of postoperative visceral pain, in order to guide individualized preoperative interventions and pain management strategies.
- Conditions
- Postoperative Visceral Pain
- Being tested
- Observational assessment of clinical outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational assessment of clinical outcomesOther
This is a non-interventional observational study. No treatment or behavioral intervention is administered.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective Cohort | This cohort includes 1000 patients whose data were collected retrospectively from existing medical records. No additional follow-up is planned. Receives: Other: Observational assessment of clinical outcomes | |
| Prospective Cohort | This cohort includes 135 patients enrolled prospectively and followed for 2 days to collect outcomes and relevant clinical data. Receives: Other: Observational assessment of clinical outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity after surgery
Pain intensity will be recorded at 6, 12, 24, and 48 hours after surgery. At each time point, the Numerical Rating Scale (NRS) pain score will be assessed both at rest and during coughing. Pain intensity was assessed using number rating scale (0-10, higher score represents worse pain intensity)
Measured: From end of surgery to 48 hours postoperatively
Secondary outcomes (2)
Postoperative Length of Hospital Stay
The total time from the end of surgery to hospital discharge will be recorded for each patient. The duration will be measured in days (d) and used to assess postoperative recovery.
Measured: From end of surgery to hospital discharge (up to 30 days)
Postoperative Analgesic Use
Detailed records will be kept of the types of analgesics administered postoperatively, the total dosage of each drug, and the frequency of use per day. This measure will help assess pain management and medication requirements after surgery.
Measured: From end of surgery to hospital discharge (up to 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start1 Jul 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Visceral 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
- Cohort
- Time perspective
- Other
- Enrolment
- 1,135 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guangyou Duan, PhD, Principal investigator, The Second Affiliated Hospital, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048782
- Sponsor's protocol ID
- vpclinicaltrial1
- Status last verified
- Jun 2025
- First submitted
- 15 Jun 2025
- Last updated
- 2 Jul 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 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Risk Prediction Model for Postoperative Visceral Pain in Abdominal Surgery Patients
- ClinicalTrials.gov ID
- NCT07048782
- Acronym / sponsor ID
- vpclinicaltrial1
- Conditions
- Postoperative Visceral Pain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,135 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 2 Jul 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 study aims to investigate the factors influencing the risk of postoperative visceral pain in patients undergoing abdominal surgery. The goal is to develop and validate a predictive model for assessing the risk of postoperative visceral pain, in order to guide individualized preoperative interventions and pain management strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective Cohort | – | Other: Observational assessment of clinical outcomesThis cohort includes 1000 patients whose data were collected retrospectively from existing medical records. No additional follow-up is planned. |
| Prospective Cohort | – | Other: Observational assessment of clinical outcomesThis cohort includes 135 patients enrolled prospectively and followed for 2 days to collect outcomes and relevant clinical data. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 to 70 years who are scheduled to undergo elective abdominal surgery under general anesthesia (including gynecological and general surgeries such as gastrointestinal and hepatobiliary procedures), with an ASA physical status of II to III, and an expected surgery duration of 2 hours or more.
Key inclusion criteria (4 listed)
- Patients undergoing elective abdominal surgery under general anesthesia (including gynecological procedures and general surgery such as gastrointestinal, hepatobiliary, etc.);
- Aged between 18 and 70 years;
- Classified as American Society of Anesthesiologists (ASA) physical status II-III;
- Expected surgery duration ≥ 2 hours.
Key exclusion criteria (6 listed)
- History of previous abdominal surgery;
- Diagnosed with chronic pain;
- Long-term use of analgesics or other psychotropic medications;
- Preoperative emergency condition;
- Presence of severe comorbidities involving major organ systems;
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 |
|---|---|---|
| Observational assessment of clinical outcomesThis is a non-interventional observational study. No treatment or behavioral intervention is administered. | Other | Prospective Cohort, Retrospective Cohort |
Primary outcome
Pain intensity after surgery
Time frame: From end of surgery to 48 hours postoperatively
Pain intensity will be recorded at 6, 12, 24, and 48 hours after surgery. At each time point, the Numerical Rating Scale (NRS) pain score will be assessed both at rest and during coughing. Pain intensity was assessed using number rating scale (0-10, higher score represents worse pain intensity)
2 secondary outcomes
Postoperative Length of Hospital Stay
Time frame: From end of surgery to hospital discharge (up to 30 days)
Postoperative Analgesic Use
Time frame: From end of surgery to hospital discharge (up to 30 days)
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 2 Jul 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.
Guangyou Duan, PhD principal investigator
The Second Affiliated Hospital, Chongqing Medical University
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 Visceral 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: opening soon, as of the sponsor's last update on 2 Jul 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)18323376014, 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?
Pain intensity after surgery (time frame: From end of surgery to 48 hours postoperatively). 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 2 Jul 2025.