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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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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