Clinical trial NCT04416386: Vitamin C Level Effect in Orthognathic Surgery
Official title: Does Vitamin C Level Effect Postoperative Analgesia in Orthognathic Surgery: a Preliminary Study?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Maxillofacial Abnormalities
Maxillofacial Injuries
Maxillofacial Trauma
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 38
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Orthognathic surgery patients aged between 19-38 years (mean age 27.17) with ASA I and ASA II status will be included in this randomized prospective study.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood plasma levels of vitamin C
timeFrame: Change from baseline blood plasma levels of vitamin C at postoperative 1, 2, 4, 8, 16 hours
Secondary outcomes:
measure: Opioid consumption
timeFrame: Change from baseline opioid consumption levels at postoperative 1, 2, 4, 8, 16 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University Hospital
state: Bagcilar
Study officials:
References:
citation: Fukushima R, Yamazaki E. Vitamin C requirement in surgical patients. Curr Opin Clin Nutr Metab Care. 2010 Nov;13(6):669-76. doi: 10.1097/MCO.0b013e32833e05bc.
citation: Jeon Y, Park JS, Moon S, Yeo J. Effect of Intravenous High Dose Vitamin C on Postoperative Pain and Morphine Use after Laparoscopic Colectomy: A Randomized Controlled Trial. Pain Res Manag. 2016;2016:9147279. doi: 10.1155/2016/9147279. Epub 2016 Oct 30.
citation: Pirbudak L, Balat O, Cekmen M, Ugur MG, Aygun S, Oner U. Effect of ascorbic acid on surgical stress response in gynecologic surgery. Int J Clin Pract. 2004 Oct;58(10):928-31. doi: 10.1111/j.1742-1241.2004.00022.x.