Chronic Postsurgical PainPhase 4ISPAINNCT06374849
Intraoperative Sufentanil and Chronic Postsurgical Pain in Non-major Scheduled Abdominal Surgery
A Phase 4 study testing phone interview in people with Chronic Postsurgical Pain and Chronic Pain, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Several risk factors for chronic postoperative pain have been identified. A series of studies have shown that administrating intraoperatively a high dose of Remifentanil is associated with an increased incidence of CPSP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Postsurgical Pain, Chronic Pain, Abdominal Surgery
- What is being tested?
- phone interview
- How many people
- 855 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jun 2024to Jul 2026
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old.
- Non-major scheduled abdominal surgery.
- Patient will receive Sufentanil intraoperatively for induction and maintenance of general anesthesia
- Written or oral informed consent to participate in the study.
Who cannot join
- Intraoperative complications that are life-threatening or require the surgical procedure to be discontinued.
- Repeat surgery at the same surgical site in less than 3 months.
- Pregnancy.
- Ambulatory surgery.
- Endoscopic surgery.
- Surgery with loco-regional or perimedullary anesthesia without general anesthesia
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- Intraoperative use of an opioid other than Sufentanil.
- Hypersensitivity to sufentanil
- Legally protected patients (under judicial protection, guardianship, curatorship).
- Patients suffering from psychiatric pathologies.
- Patients suffering from neurodegenerative pathologies.
- Patients for whom self-assessment of pain using an numerical rating scale (0-10) is not feasible (language barrier, etc…)
Trial locations and contacts
1 site in 1 country.
About this study
Several risk factors for chronic postoperative pain have been identified. A series of studies have shown that administrating intraoperatively a high dose of Remifentanil is associated with an increased incidence of CPSP. These findings highlight a risk factor for CPSP that the anaesthetist can influence on, but they however remain limited to remifentanil. To this day, no study have attempted to evaluate the existence of such an association between the incidence of CPSP and the intraoperative administration of sufentanil doses. Improved knowledge of the long-term nociceptive impact of intraoperative sufentanil administration would enable better therapeutic adaptation according to each patient's risk.
In the field of CPSP, non-major abdominal surgeries remain poorly studied. This is due to their lower risk of CPSP than other surgeries such as orthopaedic, mammary or thoracic surgery. Nevertheless, they constitute a large number of daily surgical procedures. The estimated incidence of CPSP in non-major abdominal surgery appears in several studies to be between 15 and 20% The aim of this study is to evaluate the correlation between the intraoperative administration of sufentanil doses and the incidence of CPSP at 3 months in patients undergoing non-major scheduled abdominal surgery.
- Being tested
- phone interview
- Keywords
- Chronic Postsurgical Pain, Chronic pain, Abdominal surgery, Sufentanil, Risk factors
- Medical subject headings
- Pain, Postoperative, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phone interviewOther
Patient's phone interview 3 months after operating room discharge. The interview consisting of 3 questionnaires to detect the presence of CPSP, its intensity, its characteristics and its related analgesic consumption.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of CPSP
Incidence of CPSP at 3 months after non-major scheduled abdominal surgery
Measured: at 3 months
Secondary outcomes (2)
Post-operative pain intensity
Post-operative pain intensity assessed by NRS of 11 points at 24 hours after operating room discharge
Measured: at 24 hours
Post-operative pain intensity
Post-operative pain intensity assessed by NRS of 11 points at 48 hours after operating room discharge
Measured: at 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start24 Jun 2024
- Primary completion1 Apr 2025
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Postsurgical PainStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 855 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374849
- Sponsor's protocol ID
- PI2023_843_0173
- Acronym
- ISPAIN
- Status last verified
- Nov 2025
- First submitted
- 16 Apr 2024
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Sufentanil and Chronic Postsurgical Pain in Non-major Scheduled Abdominal Surgery
- ClinicalTrials.gov ID
- NCT06374849
- Acronym / sponsor ID
- ISPAIN / PI2023_843_0173
- Keywords
- Chronic Postsurgical Pain, Chronic pain, Abdominal surgery, Sufentanil, Risk factors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 855 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- Jul 2026 (estimated)
- First posted
- 19 Apr 2024 (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.
Several risk factors for chronic postoperative pain have been identified. A series of studies have shown that administrating intraoperatively a high dose of Remifentanil is associated with an increased incidence of CPSP. These findings highlight a risk factor for CPSP that the anaesthetist can influence on, but they however remain limited to remifentanil. To this day, no study have attempted to evaluate the existence of such an association between the incidence of CPSP and the intraoperative administration of sufentanil doses. Improved knowledge of the long-term nociceptive impact of intraoperative sufentanil administration would enable better therapeutic adaptation according to each patient's risk.
In the field of CPSP, non-major abdominal surgeries remain poorly studied. This is due to their lower risk of CPSP than other surgeries such as orthopaedic, mammary or thoracic surgery. Nevertheless, they constitute a large number of daily surgical procedures. The estimated incidence of CPSP in non-major abdominal surgery appears in several studies to be between 15 and 20% The aim of this study is to evaluate the correlation between the intraoperative administration of sufentanil doses and the incidence of CPSP at 3 months in patients undergoing non-major scheduled abdominal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years old.
- Non-major scheduled abdominal surgery.
- Patient will receive Sufentanil intraoperatively for induction and maintenance of general anesthesia
- Written or oral informed consent to participate in the study.
Key exclusion criteria (12 listed)
- Intraoperative complications that are life-threatening or require the surgical procedure to be discontinued.
- Repeat surgery at the same surgical site in less than 3 months.
- Pregnancy.
- Ambulatory surgery.
- Endoscopic 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 |
|---|---|---|
| phone interviewPatient's phone interview 3 months after operating room discharge. The interview consisting of 3 questionnaires to detect the presence of CPSP, its intensity, its characteristics and its related analgesic consumption. | Other | – |
Primary outcome
Incidence of CPSP
Time frame: at 3 months
Incidence of CPSP at 3 months after non-major scheduled abdominal surgery
2 secondary outcomes
Post-operative pain intensity
Time frame: at 24 hours
Post-operative pain intensity
Time frame: at 48 hours
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 19 Nov 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing phone interview in people with Chronic Postsurgical Pain and Chronic Pain, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 12 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: under way, not looking for participants, as of the sponsor's last update on 19 Nov 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 France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of CPSP (time frame: at 3 months). 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 19 Nov 2025.