Study on the Effect of Vitamin C and Microcrystalline Cellulose on Reducing Complex Regional Pain Syndrome in Patients Undergoing Upper Limb Surgery

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What is this study about?

This clinical trial is focused on studying the effects of Complex Regional Pain Syndrome Type I (CRPS Type I), a condition that can cause severe and long-lasting pain, usually in an arm or leg, following surgery or injury. The study is particularly interested in patients undergoing major surgery on the upper limb, such as the arm or shoulder. The main goal is to see if taking Vitamin C during the time around surgery can significantly reduce the chances of developing CRPS Type I.

Participants in the study will be given either L-Ascorbic Acid, which is another name for Vitamin C, or a placebo. The Vitamin C will be provided in capsule form, and the study will monitor the participants for up to six months after their surgery to check for any signs of CRPS Type I. The study will also look at how well participants tolerate Vitamin C and how closely they follow the treatment plan.

In addition to the main focus on CRPS Type I, the study will gather information about the population affected by this condition and will continue to observe participants for up to twelve months after surgery. This will help researchers understand more about the long-term effects of Vitamin C on CRPS Type I and its potential benefits in preventing this painful condition.

1 joining the study

Upon joining the study, you will be informed about the purpose and procedures involved. You will need to provide your consent to participate, confirming that you understand the study and agree to follow the treatment and monitoring protocol.

2 pre-surgery preparation

Before your upper limb surgery, you will begin taking the study medication. This involves taking l-ascorbic acid, commonly known as vitamin C, orally. The dosage and frequency will be explained to you by the study team.

3 surgery

You will undergo the planned major surgery of the upper limb. The study aims to assess the effect of vitamin C on reducing the risk of developing complex regional pain syndrome (CRPS) after surgery.

4 post-surgery medication

After your surgery, you will continue taking l-ascorbic acid as directed. The study medication is intended to be taken for a total of six months, starting from the perioperative period, which includes the time before, during, and after your surgery.

5 follow-up assessments

Throughout the study, you will have regular follow-up assessments to monitor your health and the effects of the medication. These assessments will help determine if you develop any symptoms of complex regional pain syndrome (CRPS) within six months after surgery.

6 end of study participation

Your participation in the study will conclude after the final assessment, which occurs 12 months after your surgery. This assessment will evaluate the long-term effects of the medication and your overall health status.

Who Can Join the Study?

Patients must be over 18 years old.
Patients must be undergoing major surgery of the upper limb (such as the arm or hand).
Patients must be able to give their consent to follow the treatment and monitoring plan. Consent means agreeing to participate after understanding the study details.
Patients must have social security coverage.

Who Cannot Join the Study?

Patients who are not within the specified age range for the study.
Patients who are not undergoing upper limb surgery.
Patients who do not have CRPS type 1 (a condition also known as algoneurodystrophy).
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 Rouen	Rouen	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	18.07.2016

Trial locations

Investigated drugs:

Vitamin C is a nutrient that is important for maintaining healthy skin, blood vessels, bones, and cartilage. It also helps in healing wounds. In this clinical trial, Vitamin C is being studied to see if it can help reduce the risk of developing a condition called Complex Regional Pain Syndrome Type I (CRPS 1) after surgery on the upper limb. CRPS 1 is a painful condition that can occur after an injury or surgery, and the trial aims to find out if taking Vitamin C around the time of surgery can lower the chances of getting this condition.

Investigated diseases:

Complex regional pain syndrome

Complex Regional Pain Syndrome Type 1 – Complex Regional Pain Syndrome Type 1, also known as CRPS Type 1, is a chronic pain condition that typically affects a limb after an injury or surgery. It is characterized by prolonged or excessive pain and changes in skin color, temperature, and swelling in the affected area. The exact cause of CRPS Type 1 is not well understood, but it is believed to involve abnormal responses of the nervous system. The condition progresses through stages, starting with acute symptoms such as burning pain and swelling, followed by dystrophic changes like skin and nail alterations. In the later stages, atrophy may occur, leading to decreased movement and function of the affected limb. The progression and severity of symptoms can vary widely among individuals.

Trial ID:

2024-518310-28-00

Protocol code:

PI2015_843_0001

NCT ID:

NCT02390505

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effect of Vitamin C and Microcrystalline Cellulose on Reducing Complex Regional Pain Syndrome in Patients Undergoing Upper Limb Surgery

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?