Vitamin C Level Effect in Orthognathic Surgery

July 25, 2022 updated by: Bahadir Ciftci, Medipol University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Bagcilar
      • Istanbul, Bagcilar, Turkey, 34070
        • Istanbul Medipol University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 38 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline blood plasma levels of vitamin C at postoperative 1, 2, 4, 8, 16 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption
Time Frame: Change from baseline opioid consumption levels at postoperative 1, 2, 4, 8, 16 hours
Postoperative opioid consumption
Change from baseline opioid consumption levels at postoperative 1, 2, 4, 8, 16 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medipol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2020

Primary Completion (Actual)

March 30, 2022

Study Completion (Actual)

March 30, 2022

Study Registration Dates

First Submitted

June 2, 2020

First Submitted That Met QC Criteria

June 2, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

July 26, 2022

Last Update Submitted That Met QC Criteria

July 25, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Medipol Hospital 12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

We will not plan to share IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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