Study on Sufentanil’s Effect on Chronic Pain After Non-Major Abdominal Surgery for Patients

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What is this study about?

This clinical trial is focused on studying the effects of the medication sufentanil during surgery and its relationship with chronic postsurgical pain in patients undergoing non-major scheduled abdominal surgery. Sufentanil is a strong pain-relief medication given as a solution for injection during surgery. The purpose of the study is to understand how the doses of sufentanil given during surgery might affect the occurrence of chronic pain three months after the surgery.

Participants in the study will receive sufentanil during their surgery, and the study will monitor their pain levels at different times: 24 hours, 48 hours, and three months after the surgery. The study will also look at how much pain medication is needed after surgery and how intense the pain is at three months. This will help researchers learn more about how to manage pain after surgery and improve recovery for future patients.

The study will take place over a period of time, with the aim of gathering information on how sufentanil affects pain management in abdominal surgeries that are not considered major. By understanding the connection between sufentanil use and chronic pain, the study hopes to find better ways to prevent long-term pain after surgery.

1 joining the trial

Eligibility is determined based on age (over 18 years) and the type of surgery (non-major scheduled abdominal surgery).

Consent is required to participate in the trial.

2 pre-surgery preparation

Preparation for surgery includes standard pre-operative procedures.

No specific trial-related activities occur at this stage.

3 surgery and medication administration

During surgery, the medication sufentanil is administered via infusion.

The objective is to evaluate the correlation between the doses of sufentanil given during surgery and the incidence of chronic postsurgical pain (CPSP) at 3 months.

4 post-operative monitoring

Pain intensity is assessed using a numerical rating scale (NRS) of 11 points at 24 hours and 48 hours after discharge from the operating room.

The time taken until the use of third-step pain relief medications is recorded.

5 follow-up assessments

Consumption of opioid derivatives and opioids is monitored at 24 hours, 48 hours, and 3 months after surgery.

The intensity of CPSP and the incidence of neuropathic pain are evaluated at 3 months.

Who Can Join the Study?

Must be over 18 years old.
Scheduled to have a non-major abdominal surgery. This means a planned surgery on the belly area that is not considered very complex or risky.
Must give informed consent to participate. This means you agree to join the study after being told all the important details about it, either by signing a form or saying yes.

Who Cannot Join the Study?

Patients who are not scheduled for non-major abdominal surgery.
Patients who do not have chronic pain after surgery.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	17.03.2024

Trial locations

Investigated drugs:

Sufentanil

Sufentanil is a medication used during surgery to help manage pain. In this clinical trial, it is given to patients during their abdominal surgery to see if it affects the development of chronic pain three months after the operation. The study aims to understand if the amount of Sufentanil given during surgery has any impact on long-term pain outcomes for patients.

Investigated diseases:

Procedural pain

Chronic Postsurgical Pain – This condition occurs when pain persists for more than three months following surgery, in this case, after non-major scheduled abdominal surgery. It is characterized by pain that continues beyond the normal healing period and is not due to other causes such as infection or a recurrence of the original problem. The pain can vary in intensity and may be accompanied by sensations such as burning or tingling. It can affect the quality of life and may interfere with daily activities. The exact cause is not always clear, but it may involve nerve damage or changes in the nervous system.

Trial ID:

2023-510140-21-00

Protocol code:

PI2023_843_0173

Trial Phase:

Therapeutic confirmatory (Phase III)

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