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Completed

NCT Number: NCT04416386

Vitamin C Level Effect in Orthognathic Surgery

Comparing the pre and post-operative blood plasma levels of vitamin C according to oxidative stress and investigate the correlation between post-operative analgesia requirement and vitamin C levels following orthognathic surgery.

Completed

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Key information

About this study

Vitamin C (ascorbic acid) is a water-soluble vitamin that has many functions include antioxidant, neuroprotective, neuromodulator and co-factor for various enzymes or chemical reactions. Primarily ascorbic acid is the most potent non-enzymatic antioxidant agent in an extracellular fluid which is crucial for defense against oxidative stress. Recent clinical studies have shown that trauma or surgery may lead to oxidative stress and plasma vitamin C level decreases due to body demand that most likely caused by oxidative stress.

Pain is defined as an unpleasant sensory and emotional experience associated with actual or potential tissue damage. One of the major purposes in the management of post-operative pain is to minimize the dose of medications to reduce side effects while providing adequate analgesia.

In orthopedic surgery and management of postherpetic neuralgia oral vitamin C supplementation significantly reduced pain. However, the decrease in vitamin C concentration,the effects on antinociception and postoperative pain are not fully understood.

In this study, investigators aimed to compare pre and post-operative blood plasma levels of vitamin C after orthognathic surgery and investigate a correlation between post-operative analgesia requirement and vitamin C levels without vitamin C administration.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Society of Anesthesiologists (ASA) classification I-II
  • Scheduled for orthognatic surgery under general anesthesia

Exclusion criteria

  • history of bleeding diathesis,
  • receiving anticoagulant treatment,
  • known local anesthetics and opioid allergy,
  • infection of the skin at the site of the needle puncture,
  • pregnancy or lactation,
  • patients who do not accept the procedure

Treatment and study plan

Vitamin C

Other

Pre and post-operative blood plasma levels of vitamin C will be investigated

Primary outcomes

  1. Blood plasma levels of vitamin C

    Time frame: Change from baseline blood plasma levels of vitamin C at postoperative 1, 2, 4, 8, 16 hours

    Pre and post-operative blood plasma levels of vitamin C

Secondary outcomes

  1. Opioid consumption

    Time frame: Change from baseline opioid consumption levels at postoperative 1, 2, 4, 8, 16 hours

    Postoperative opioid consumption

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

Does Vitamin C Level Effect Postoperative Analgesia in Orthognathic Surgery: a Preliminary Study?

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 4, 2020
Registry last updated
Jul 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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