| CTRI Number |
CTRI/2025/10/096373 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Studying how Vitamin C affects post-surgical pain in patients having Head and Neck Surgery. |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jassica Charles |
| Designation |
Postgraduate Registrar |
| Affiliation |
Christian Medical College Vellore |
| Address |
Department of Anaesthesia,
Christian Medical College Vellore
Vellore TAMIL NADU 632004 India |
| Phone |
9988106054 |
| Fax |
|
| Email |
jassica1997@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Serina Ruth Salins |
| Designation |
Professor |
| Affiliation |
Christian Medical College Vellore |
| Address |
Department of Anaesthesia,
Christian Medical College Vellore
Vellore TAMIL NADU 632004 India |
| Phone |
9442307738 |
| Fax |
|
| Email |
serina.ruth@cmcvellore.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Serina Ruth Salins |
| Designation |
Professor |
| Affiliation |
Christian Medical College Vellore |
| Address |
Department of Anaesthesia,
Christian Medical College Vellore
Vellore TAMIL NADU 632004 India |
| Phone |
9442307738 |
| Fax |
|
| Email |
serina.ruth@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| Internal Fluid Research Grant
Christian Medical College Vellore
Vellore
Tamil Nadu 632002
India |
|
|
Primary Sponsor
|
| Name |
Christian Medical College Fluid Research Fund |
| Address |
Office of Research
Christian Medical College
Vellore
Tamil Nadu 632002
India
|
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jassica Charles |
Christian Medical College |
Operation Rooms Christian Medical College Vellore Vellore TAMIL NADU |
9988106054
jassica1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Christian Medical College, Vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Dose of Placebo 100ml Normal saline
Frequency Once
Route of administration Intravenous
Total duration of this intervention 20 minutes
All the patients in this arm will be given Injection Normal Saline solution total of 100ml intravenously over 20 minutes post induction of anaesthesia as a single dose |
| Intervention |
Vitamin C |
Dose of Vitamin C 3g (30ml)
Frequency Once
Route of administration Intravenous
Total duration of this intervention 20 minutes
All the patients in this arm will be given Injection Vitamin C 3g (30ml) in 70 ml of Normal Saline solution (Total of 100ml) intravenously over 20 minutes post induction of anaesthesia as a single dose |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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). |
6 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
03/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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.
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