Vitamin C Level Effect in Orthognathic Surgery

Maxillofacial Abnormalities Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04416386
• Other study ID #: Medipol Hospital 12
• Status: Completed
• Start date: June 13, 2020
• Est. completion date: March 30, 2022

Study information

• Verified date: July 2022
• Source: Medipol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 30, 2022
• Est. primary completion date: March 30, 2022
• Gender: All
• Age group: 19 Years to 38 Years

Eligibility

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

Related Conditions & MeSH terms

• Maxillofacial Abnormalities
• Maxillofacial Injuries
• Maxillofacial Trauma

Intervention

Other:
• Vitamin C
Pre and post-operative blood plasma levels of vitamin C will be investigated

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University Hospital	Istanbul	Bagcilar

Sponsors (1)

Lead Sponsor	Collaborator
Medipol University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. Review. — View 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. Epub 2016 Oct 30. — View Citation

Pirbudak L, Balat O, Cekmen M, Ugur MG, Aygün S, Oner U. Effect of ascorbic acid on surgical stress response in gynecologic surgery. Int J Clin Pract. 2004 Oct;58(10):928-31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood plasma levels of vitamin C	Pre and post-operative blood plasma levels of vitamin C	Change from baseline blood plasma levels of vitamin C at postoperative 1, 2, 4, 8, 16 hours
Secondary	Opioid consumption	Postoperative opioid consumption	Change from baseline opioid consumption levels at postoperative 1, 2, 4, 8, 16 hours