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Clinical Trials/CTRI/2025/10/096373
CTRI/2025/10/096373Not yet recruitingPhase 2

The Effect of Intra-operative Intravenous Vitamin C Supplementation on post-operative pain in patients undergoing Reconstructive Head and Neck Flap Surgeries: A Randomized Controlled Trial.

Christian Medical College Fluid Research Fund1 site in 1 country70 target enrollmentStarted: November 3, 2025Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
70
Locations
1
Primary Endpoint
To assess the effect of Vitamin C supplementation in postoperative pain (VAS score at 6 hours) in patients undergoing reconstructive Head and Neck flap surgeries (local and pedicled flap).

Study Overview

Brief Summary

Pain is defined by the International Association for the Study of Pain (IASP) as An unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage. It is a complex phenomenon that includes both sensory-discriminative and motivational-affective components. The sensory discriminative component of pain depends on ascending projections of tracts (Spinothalamic tracts) to the cerebral cortex. The motivational affective responses to painful stimuli include attention and arousal, somatic and autonomic reflexes, endocrine responses and emotional changes.

Postoperative pain is present in up to 80 percentage of patients undergoing surgery, and is of significant concern. It impairs the quality of life (such as sleep quality and level of activity) and impacts patient recovery, opioid consumption, and overall hospital stay and contributes to chronic postoperative pain.

The commonly used postoperative analgesic agents include opioids and nonsteroid anti inflammatory drugs (NSAIDs) are associated with untoward side effects including respiratory depression and other complications such as nausea or vomiting. In addition, NSAIDs, which are usual adjuvants to opioid-based regimens, are known to contribute to adverse gastrointestinal, renal side-effects and bleeding.

The goal of this study is to evaluate the effectiveness of intravenous Vitamin C in reducing pain. Vitamin C, the L enantiomer of ascorbate also known as ascorbic acid, is a water-soluble antioxidant ubiquitously present in a variety of fruits and vegetables. The importance of vitamin C in wound healing and hemostasis was first realized more than 260 years ago when it was found to be a cure for scurvy, a disease characterized by spontaneous bleeding, anemia, and gum ulceration. Besides its role in hemostasis, vitamin C is also known to exhibit analgesic functions. Recent evidence has attributed the antinociceptive action of Vitamin C to its antioxidant, neuroprotective, and neuro-modulatory properties. Vitamin C has been shown to reduce acute pain and the prevalence of complex regional pain syndromes (CRPS) with its antinociceptive effect. Considering that intravenous vitamin C can trigger oxidative hemolysis with glucose 6 phosphate dehydrogenase (G6PD) deficiency, we will be screening the patients for G6PD activity prior to their inclusion in the study.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
17.00 Year(s) to 64.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients who give consent for head and neck flap (local and pedicle) surgery and intravenous Vitamin C ASA 1 and ASA 2 G6PD normal patients Hemodynamically stable patients undergoing head and neck reconstructive flap surgeries.

Exclusion Criteria

  • Age below 17 years and above 65 years Patient who refuse to be a part of the study ASA 3 and above patients (cardiac and renal failure patients) Pregnant women G6PD deficient patients Patient with history of allergy to Vitamin C History of chronic opioid use.

Outcomes

Primary Outcomes

To assess the effect of Vitamin C supplementation in postoperative pain (VAS score at 6 hours) in patients undergoing reconstructive Head and Neck flap surgeries (local and pedicled flap).

Time Frame: 6 hours postoperatively

Secondary Outcomes

  • VAS score at 0,12 and 24 hours postoperatively(0,12 and 24 hours)
  • Time to rescue analgesic request(Till 24 hours postoperatively)
  • Measure the amount of postoperative analgesic requirement(Till 24 hours postoperatively)
  • To evaluate the length of hospital stay(Date of discharge)

Investigators

Sponsor
Christian Medical College Fluid Research Fund
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Jassica Charles

Christian Medical College Vellore

Study Sites (1)

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